Get the brand new NDC Express mobile application by downloading it now! With our brand-new mobile app, searching the NDC Directory is now both quicker and less difficult. Download NDC Express Directorio de Códigos Nacionales de Medicamentos (Spanish Version) Information on completed drug products, unfinished pharmaceuticals, and compounded drug products may be found in the National Drug Code (NDC) Directory that is maintained by the FDA.
- trong Completed pharmaceutical products The Food and Drug Administration (FDA) requires that drug establishments furnish a current list of all pharmaceuticals that are made, prepared, propagated, compounded, or processed at their facilities for sale in the United States;
The National Drug Code, or NDC for short, is a three-segmented, one-of-a-kind number that is used to identify pharmaceuticals and report them to the FDA. This number acts as the FDA’s identifier for drugs. The NDC Directory, which is maintained by the FDA and updated on a daily basis, is where the mentioned NDC numbers may be found.
- Information about active and certified finished and unfinished medications that have been submitted to the FDA by labelers in the form of electronic listing files using the structured product labeling (SPL) format may be found in the NDC Directory;
A manufacturer, including a repackager or relabeler, or the business listed on the product label might be considered to be the product’s labeler. The NDC Directory provides product listing data that has been filed for all completed pharmaceuticals. This includes prescription and over-the-counter drugs, drugs that have been authorized and drugs that have not been approved, as well as drugs that have been repackaged and relabeled.
- Unfinished medication A current list of all drugs that are manufactured, prepared, propagated, compounded, or processed in commercial distribution in the United States at the drug establishments that produce active pharmaceutical ingredients must be provided to the FDA by the drug establishments that produce active pharmaceutical ingredients;
The National Drug Code (NDC) unfinished medicines database provides product listing data that was filed for all unfinished medications. This includes active pharmaceutical components, drugs that are intended for additional processing, and bulk drug substances that are intended for compounding.
Drug items that have been compounded Information on final compounded human medicine products that have been created by outsourcing facilities that have made the decision to assign NDCs to their goods is also included in the NDC Directory.
Outsourcing facilities, which are a type of drug compounding facility regulated under Section 503B of the FD&C Act, may be eligible for exemptions from the requirements for drug registration and listing if they satisfy the conditions outlined in Section 503B.
However, this only applies if the outsourcing facility is also a drug compounding facility. It is possible for outsourcing facilities to issue NDCs to the completed compounded human medicine products that they produce, but this is not a requirement for them.
Upon initial registration, as well as between June and December of each year afterwards, outsourcing facilities are obligated to supply the FDA with a list of the pharmaceuticals that they have compounded during the most recent preceding six-month period.
The information contained in these product reports is incorporated into the NDC Directory. Only compounded drug goods that have been issued an NDC and have been reported as falling under the marketing category “Outsourcing Facility Compounded Human Drug Product (Exempt from Approval Requirements)” are included in the NDC Database.
Information that has been reported to FDA during the past two years will be included in the search results (last four reporting periods). * * Beginning with the 2021-2 reporting period, i. e., June 1, 2021, through November 30, 2021, the inclusion of compounded drugs in the NDC Database will coincide with the use of the marketing category “Outsourcing Facility Compounded Human Drug Product (Exempt from Approval Requirements).” This will allow compounded drugs to be sold without having to go through the approval process. Important things to keep in mind with regard to the NDC Directory
The inclusion of a product in the NDC Directory does not imply that the FDA has validated the information that was supplied or that the product has been authorized by the FDA. The labeler who sends in the SPL file is the one who is responsible for the information that is included in each NDC Directory item. The distribution of a product’s NDC number does not in any way signify that the product has been approved by the FDA. Any portrayal of a product that gives the idea that it has been approved by the FDA just because it has an NDC number is deceptive and in violation of federal law.
Inclusion in the NDC Directory or receipt of an NDC number does not indicate that a product fulfills the requirements for classification as a drug under federal law. Simply because a product is included in the NDC Directory does not mean that it is covered by Medicare, Medicaid, or any other payer, nor does it mean that it is eligible for reimbursement.
It is against the rules to provide an NDC number to something that isn’t a drug. The NDC Directory does not include all of the medications that are mentioned. It does not include medicines derived from animals, blood products, medicines produced under contract, or medicines that are sold exclusively as part of a kit, combination product, or as an inner layer of a multi-level packaged product and are not sold separately.
- There are product entries in the NDC Directory that have achieved their marketing start date, but have not yet reached their marketing end date, if that information was supplied;
- The day when the labeler declares that the product has commenced commercial distribution is referred to as the marketing start date;
A non-disclosure agreement (NDC) will not be able to be publicized until the specified future date has passed. At the time of delisting, the labeler will specify a “marketing end date” in order to indicate when the product will be removed from circulation in the marketplace.
- The presence of a future marketing end date indicates that the product has been delisted; nonetheless, the NDC will continue to be active until the date in question is reached;
- The NDC Directory includes compounded drug goods that have been reported during the past two years using the marketing category “Outsourcing Facility Compounded Human Drug Product (Exempt from Approval Requirements)” and the allocated NDC (last four reporting periods).
Adding to, fixing errors in, or otherwise modernizing the NDC Directory Regarding both finished pharmaceuticals and unfinished pharmaceutical products: It is possible to add, edit, or update product listing information in the NDC Directory by submitting a new or revised product listing using SPL;
The Food and Drug Administration (FDA) does not submit or change any registration or listing data. The firm that is providing the information to the FDA is responsible for ensuring that the data on the listing are accurate. Through the use of its compliance procedures, the organization ensures the correctness and integrity of the data.
For further information, please refer to the DRLS guidelines. Regarding compounded medications: Facilities that outsource their compounding activities are required to provide product reports for compounded pharmaceuticals twice yearly and have the ability to amend this information at any time.
In order to add, amend, or update product reporting information that is shown in the NDC Directory, outsourcing facilities should submit new or updated product reporting information using SPL (see FDA guidance document on product reporting for outsourcing facilities).
Questions Check out the many points of contact for registration and listing of drugs. [email protected] is the email address to use if you need help with medication preparation. Other Citations and References
Carry out a search through the National Drug Code Directory.
The text version of the NDC database file (zip format) NDC database file – Excel version (zip format) NDC file for the database of unfinished medications (zip format) Compounding medicines included in the NDC database file (zip format) Drugs database file was not included in the NDC database (zip format) NDC product file definitions The definitions of the NDC package files Application Programming Interface for NDC (NDC API) (Firefox and Chrome recommended).
Is NDC the same as Rx?
The assignment of a National Drug Code is part of the obligation for the Food and Drug Administration (FDA) to electronically list drug items (including prescription and over-the-counter varieties), as mandated by the Drug Listing Act of 1972. (NDC). An NDC is a ten-digit number that identifies a drug product in a way that is both unique and universal. This number is created by connecting together three different code segments using hyphens. Once upon a time, certain configurations of the NDC would be denoted with an asterisk; however, this practice is no longer followed.
- A full NDC has dashes between each segment and consists of a labeler code, a product code, and a packaging code segment;
- The segments are separated by the labeler code;
- The NDC Directory does not include all of the mentioned pharmaceuticals, but it will include all over-the-counter (OTC), prescription, and insulin packages that are sold in the United States of America;
The directory will not include pharmaceuticals intended for animals, blood products, or human beings that are not yet in their final form to be sold. Having a National Drug Code (NDC), on the other hand, does not guarantee clearance from the FDA. Code Configurations The forms 5-3-2 and 5-4-1 are the two ways that NDCs can be constructed.
- Even though 5-3-2 is the style that labelers use the vast majority of the time, there are certain businesses who discover that 5-4-1 works better for them;
- This is due to the fact that 5-4-1 provides for ten times the amount of product codes than 5-3-2 does;
However, 5-4-1 imposes a cap of ten on the total number of package codes that can be used for each product (0-9). It is essential to keep in mind that a labeler must choose and adhere to one of these forms as their standard, and not both. The Food and Drug Administration does not let manufacturers to choose between 5-3-2 and 5-4-1 based on which method is most practical for their products.
When deciding on a format, labelers should give serious consideration not only to the product portfolios and package configurations of their existing products, but also to any plans they have for the future product offerings.
First Segment – The Labeler Code The NDC Labeler Code is the initial part of the NDC, making up the entirety of the first segment. The firm that is accountable for the distribution of the goods throughout the United States is identified by a Labeler Code, which consists of five digits (with certain exceptions for older codes, which may only be four).
The FDA is solely responsible for allocating one component of the NDC, and that is the Labeler Code. The labeler firm is responsible for the assignment of the remaining components, which are then registered with the FDA through the electronic drug listing process.
This gives those responsible for labeling the ability to select between the 5-3-2 or the 5-4-1 set up. You are required to provide the Food and Drug Administration (FDA) with an electronic NDC Labeler Code Request in order to get a labeler code. In the hypothetical instance of the NDC that we looked at before, the labeler code was 12345.
- In the database maintained by the FDA, the code would be linked to the name of the labeler; for example, “Acme Medicine Company.” After the Food and Drug Administration (FDA) has issued a labeler code, that code will be used as the starting point for all of that labeler’s goods;
For example, the National Drug Code (NDC) for every Acme product would start with the code 12345. The Product Code is the Subject of the Second Part The product in issue may be pinpointed using the product code portion of the segment. For instance, a tablet with a coating of 200 milligrams of ibuprofen that was manufactured by the same labeler would have the same product code in all of its many package configurations.
Therefore, in the above illustration, NDC 12345-123 can refer to an ibuprofen tablet with a coating of 200 milligrams that is marketed by Acme Medicine. If Acme sold a variant of this product that included a distinguishing quality—for instance, an ibuprofen liquid capsule containing 200 milligrams—it would be assigned a unique product code (e.
, 12345-124). The Third Part Is Known As The Package Code The package code is the very last part of a National Distribution Code. The package code identifies the many configurations in which the product is made available for purchase. For example, the National Drug Code (NDC) 12345-123-01 may be used to identify a film-coated tablet containing 200 milligrams of ibuprofen that Acme sells in bottles of 25 tablets.
It’s possible that the NDC 12345-123-02 refers to a container containing 100 of the identical pills. Each NDC code, once registered, serves as a representation of the product and is linked to any information that is relevant inside the NDC directory.
These details include the brand name, the non-brand name (often known as the generic name), the dose, the mode of administration, and the kind of product, such as over-the-counter or prescription. The 11-digit code used for billing conversion Instead of the 10 digit National Drug Code that is written on labels, proper billing of a National Drug Code requires an 11 digit NDC, formatted in the following way: 5-4-2.
The 10 digit code may be quickly transformed to an 11 digit code by placing a ‘0’ in a specific position at the beginning of whatever segment in the 10 digit number is not long enough for the 5-4-2 format.
This conversion can be done in a matter of seconds. Taking a look back at our earlier illustration, the NDC 12345-123-01 may identify Acme’s film-coated ibuprofen tablet with 200 milligrams, which is sold in a container containing 25 tablets; but, in order to be used for invoicing, it will need to be transformed to 11 digits.
This conversion may be done by looking at the current number, which is formatted in the 5-3-2 manner, and determining where adding a zero would alter the format to the 5-4-2 manner. In this scenario, the middle segment will be affected, resulting in a change to the billing code to NDC 12345-0123-01.
This 11-digit number can also be utilized for reasons other than billing by a variety of government organizations or commercial companies. Questions? Despite the significance they hold, NDCs are only a minor part of the electronic medication listing procedure utilized by the FDA.
Although the material presented above covers the fundamentals, you may still have numerous concerns regarding the process of assigning NDCs to your medicinal items, electronically listing them, and updating the data on drugs already listed.
Ever from the beginning of electronic medication listing, Reed Tech has been there to support the producers and labelers of pharmaceutical products. Please do not hesitate to get in touch with us, and one of our seasoned professionals will be happy to assist you.
What is the NDC used for?
The National Drug Code, often known as the NDC, is a ten-digit number that is broken up into three segments. In the United States, it serves as a universal product identification for all human pharmaceuticals. The code may be found on the packaging and the inserts of all over-the-counter (OTC) and prescription medications sold in the United States.
How many NDC codes are there?
Distribution: Approximately sixty percent of the codes were in the form 5-3-2. Roughly 10% of the total population had the form 4-4-2, whereas the remaining 90% had the form 5-4-1. There was a total of 252,355 NDC codes, and there were a total of 6,532 distinct labelers (companies).
Are all NDC numbers 11 digits?
It is important to take note that the majority of National Drug Codes (NDC) are printed in a 10-digit format on the packaging of drugs. An 11-digit number organized in the style of 5-4-2 is required for accurate billing of a National Drug Code (NDC).
Where is the NDC number on a prescription bottle?
- On all drug-related medical claims, the National Drug Code (NDC), NDC units, and NDC unit qualifier are required to be included as per the current standard practice in the industry. The National Drug Code (NDC) is a 12-digit number that may be used to separate and identify pharmaceuticals that have the same Healthcare Common Procedure Coding System (HCPCS) code for drug preferences. It can also assist uncover billing problems and enhance payment procedures.
- In accordance with the standards outlined by the Centers for Medicare & Medicaid Services (CMS), we suggest that the following information be provided in the appropriate areas on medical claims pertaining to prescription drugs: Please be aware that this does not affect the inpatient claims processed by hospitals or other facilities;
Why do we ask for the NDC, NDC units, and NDC unit qualifiers on claims for drug-related medical services rendered by providers and outpatients? NDCs, which are the industry standard for identifying medications, provide for complete openness regarding the prescription that is being prescribed. They include precise information on the manufacturer, the name of the medicine, the dose, the strength, the package size, and the amount.
- Should NDC and NDC units be included in the billing for pharmaceuticals that are purchased through an outpatient department of a hospital? Yes. The NDC would apply to hospital outpatient claims in order to ensure consistency in the criteria for the invoicing of claims.
- What specific NDC information needs to be provided on the claims? The following items of information need to be included in claims:
- Valid 11-digit NDC number
- a unit of measurement known as the NDC (F2, GR, ML, or UN)
- NDC units dispensed/administered (must be greater than 0)
Where exactly can one find the NDC? The NDC may be found on the label of the container containing the prescribed medication (e. , vial, bottle, or tube). The National Medication Code, or NDC, is a number that may be used to identify any drug or drug-related item. The National Distribution Control Number (NDC) is a string of 11 numbers that are broken up into three parts by hyphens and organized in the manner 5-4-2.
(e. , 12345-1234-12). The Food and Drug Administration of the United States assigns the first five digits of the drug’s identification number, which are used to identify the drug’s producer (FDA). The remaining numbers are given by the manufacturer, who uses them to identify the particular product as well as the size of the packaging.
If the NDC that is printed on the label does not contain a complete sequence of 11 digits, you will need to add a leading zero to the relevant area in order to make a 5-4-2 arrangement. On the claim, the NDC numbers should not include any spaces or hyphens at any point. For several instances, please see the table that follows:
|NDC on label||NDC with addition of leading zero to total 11 digits||Final NDC format to submit on medical claim|
- In what other kinds of places might information concerning NDCs be found? Information about the NDC may be found in the package insert that the FDA provides for medications. At www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory, the FDA also provides a National Drug Code Directory that may be browsed and searched online, in addition to an NDC Database file that can be downloaded. An NDC-to-HCPCS crosswalk is available online at www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/2019ASPFiles.html from the Centers for Medicare & Medicaid Services (CMS). This crosswalk may be found in the 2019 ASP Drug Pricing Files.
- Are NDC units different from HCPCS and CPT code units? Yes. It’s important to note that NDC units are not the same as HCPCS or CPT code units. You must continue to send in your HCPCS codes and service units since they are the factors that are utilized to calculate compensation. The numeric quantity that was given to the patient as well as the unit of measure are used to determine an NDC unit’s value (UOM). For further clarification, please refer to the table below:
|UOM *||Description||General guidelines|
|F2||International Unit||International units will be used when billing.|
|GR||Gram||Grams are usually used when an ointment, cream, inhaler or bulk powder jar are dispensed. It is not typically used for physician-administered drug billing.|
|ML||Milliliter||If a drug is supplied in a vial in liquid form, bill in millimeters.|
|UN||Unit||If a drug is supplied in a vial in powder form, bill each vial used.|
*Note: The ME billing qualifier is also recognized and can be used to specify milligrams as the NDC unit of measure. However, medication prices are typically determined at the ML or UN level. It is advised that the milligrams be invoiced in an equal decimal format of grams if the medicinal product in question is billed using milligrams as the unit of measurement. NDC units On the claim, you will need to provide both the exact decimal quantity that was administered and the units of measurement. 5 if three 0.5 ml vials are issued),
- GR 0. 045
- ML 1. 5
- UN 2
The amount can have a maximum of eight digits before the decimal point and a maximum of three digits after the decimal point in terms of its total number of digits. You should not use a decimal if you are inputting a full number. Leave the remaining fields blank, and do not use commas or fill in zeros for any of the numbers. For further clarification, please consider the following examples:
- 1234. 56
- 12345678. 123
What are the requirements for submitting a Not Otherwise Classified Drug (NOC)? One of the following is an example of a medicine that does not require a NOC in box 24G:
- Put in the exact same amount of HCPCS units as you did for the NDC units.
- Enter 1 as a default
What should be done in the event that a single HCPCS code has several NDCs? If there is more than one NDC used inside an HCPCS code (i.e. when there are several medication strengths used), then each appropriate NDC should be submitted as a distinct claim line. On each claim line, there has to be a corresponding NDC, NDC unit, and NDC unit qualifier for every medication code that has been filed. When more than one NDC has to be billed for a service code, standard HCPCS or CPT code billing allows for the inclusion of the following modifiers to determine the total amount due: Paper claims
- KP — First drug of a multiple drug unit dosage formulation
- KQ refers to the second or subsequent medication in a multiple drug unit dosage formulation.
- KO – Single medication unit dosage formulation
- Electronic claims In order to properly report the compound medication, you will need to iterate both the LIN and CPT segments contained inside the 2410 identification loop.
- Should I use the NDC information that is printed on the box if the drug arrives in a box with numerous vials, or should I use the NDC information that is printed on each individual vial? The NDC information that is being sought can be found on the vial that was used to give the medication to the patient, together with the relevant unit of measure and the NDC quantity that was used.
- How should the non-disclosure agreement (NDC), the unit of measure, and the amount be submitted? Please follow these instructions to submit the NDC along with the unit of measure and quantity: Forms CMS-1500 for making claims (paper) Enter the National Drug Code (NDC) in the shaded region of the service lines in field 24A of the paper CMS-1500 claim form. This will allow you to submit the NDC, as well as the unit of measure and amount.
- In order to provide room for the provision of supplementary information to support the billed service, the six service lines in section 24 have been separated horizontally. The highlighted region at the very top of each of the six service lines serves as the spot where supplementary information should be reported.
- It is required that the qualifier N4 come before the NDC, which is then immediately followed by the 11-digit NDC number (e. N412345678901).
Add the following sequence in this order when inputting additional information for NDC: N4 qualifier, 11-digit National Drug Code, one space, two-character unit/basis of measurement qualifier, if appropriate (i.e., units “UN,” international units “F2,” gram “GR,” or milliliter “ML”), and amount. On the claim, you will need to provide both the exact decimal quantity that was administered and the units of measurement. If you are reporting a partial unit, use a decimal point (i. , if three 0. 5 ml vials are distributed, record ML 1. 5). (i. , if three 0. 5 ml vials are dispensed, report ML 1.
If reporting a partial unit, use a decimal point. (that is, you should report ML 1. Represent each NDC on a claim line using the relevant drug code if the medication that is being given to the patient is made up of more than one component (for example, if the medication is a compound or the same medicine but in various dosage strengths).
5). For more illustration, kindly refer to the following:
- GR 0. 045
- ML 1. 5
- UN 2
The amount can have a maximum of eight digits before the decimal point and a maximum of three digits after the decimal point in terms of its total number of digits. You should not use a decimal if you are inputting a full number. Leave all of the remaining fields blank, and do not use commas or fill in zeros for the numbers. For further clarification, please consider the following examples:
- 1234. 56
- 12345678. 123
Forms UB-04 for making claims (paper) Please input the following information for each field in order to submit the National Drug Code (NDC), the unit of measure, and the amount for paper UB-04 claim forms:
- Revenue code can be found in field 42.
- NDC 11-digit number, unit of measurement qualifier, and unit quantity are all included in Field 43.
- HCPCS code is located in field 44.
EDI requirements: Professional claims (837 Professional) The identifying loop number should be 2410 when submitting the NDC, as well as the unit of measure and the amount, for professional claims, and:
In the LIN section, both the NDC qualifier N4 and the NDC code are sent.
- LIN02 – NDC Qualifier
- LIN03 – NDC Code
The CTP section is where the quantity as well as the unit of measure are sent.
- CTP04 is the Quantity
- CTP05-1: The Measurement System Exam
The patient’s identification number, often known as the link sequence number (to report components for a compound drug)
- The Link Sequence Number is denoted by REF01, while the Prescription Number is denoted by XZ.
- Link Sequence Number or Prescription Number, This Is REF02
For specific instances, kindly refer to the table that is provided below: Extra details may be found here. Please contact Cigna Customer Service at the following number: 1. 800. 88Cigna if you have any queries or require any further information (882. 4462).
Are NDC numbers required?
|[Code of Federal Regulations]|
|[Title 21, Volume 4]|
|[CITE: 21CFR201. 2]|
|CHAPTER I–FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES|
|SUBCHAPTER C – DRUGS: GENERAL|
What do the first 5 digits of an NDC number represent?
These files contain this variable in their respective entirety: A code in the format of the National Drug Code (NDC) that identifies the medication, medical equipment, or supply that is covered by this claim. Comments The NDC is reported using a format that has 11 digits and is broken up into three portions.
The first five digits indicate the manufacturer or the labeler; the following four digits identify the substance; the fifth and sixth digits show the strength; the seventh and eighth numerals indicate the dosage form; and the eighth and ninth digits indicate the packaging.
The FDA is in charge of assigning the manufacturer section of the code, while the manufacturer is responsible for providing the remaining information. The first five positions are numerical. Positions 6-9 are made up of alphabetic characters. Positions 10 and 11 might be either alphabetic or blank. ORIGIN: Claims found in the T-MSIS Analytic File (TAF).
|Null/missing||source value is missing or unknown|
Do NDC codes expire?
When billing using NDCs on professional/ancillary/facility electronic (837P or 837l) or paper (CMS-1500) claims, it is necessary to make sure that the NDC that is being utilized is still valid for the date that the service was rendered. This is due to the fact that NDCs can become outdated or be altered.
What is RX number?
RXSchool Episode 5 – National Drug Code (NDC)
Number of the Prescription (Rx being an abbreviation for prescription ). This number is uniquely associated with YOUR prescription. The order in which prescriptions are filled at the pharmacy determines the sequence in which the numbers are assigned. If you provide the pharmacy personnel this number when you call for a refill, they will be able to quickly identify your prescription.
What is the NDC number for b12 injection?
Can the same drug have different NDC?
What does an NDC code stand for? – A one-of-a-kind number consisting of 10 digits and three segments is allotted to every medication product that is listed. This number, which is referred to as the National Drug Code (NDC), is used to identify the labeler, product, and trade package size.
The Food and Drug Administration will provide you with the first part, which is the labeler code. The National Drug Code (NDC) is printed anywhere on the product’s outside package. You can search for the medicine using this number to discover one that is a precise match.
For instance, one and the same medication may be manufactured by a variety of companies, or one and the same medication may have many dosing options. The NDC code would be different for each one of them, which would make it possible for you to differentiate between the various outcomes.
What is an Rx number?
Number of the Prescription (Rx being an abbreviation for prescription). This number is uniquely associated with YOUR prescription. The order in which prescriptions are filled at the pharmacy determines the sequence in which the numbers are assigned. If you provide the pharmacy personnel this number when you call for a refill, they will be able to quickly identify your prescription.
What does NDC mean on prescription bottle?
The abbreviation “NDC” refers to the National Drug Code. It is a three-segment numeric identification that is specific to each drug that is listed in accordance with Section 510 of the Federal Food, Drug, and Cosmetic Act of the United States of America.
Where does the NDC number go on a claim?
Valid 11-digit NDC number. The National Drug Code (NDC) has to be placed into either the 24D field of the CMS-1500 form or the LIN03 section of the HIPAA 837 Professional Electronic form. NDC is the unit of measure used (F2, GR, ML, UN). NDC units dispensed (must be greater than 0).