What Does Ndc Stand For Pharmacy?

What Does Ndc Stand For Pharmacy
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.

  1. trong Completed pharmaceutical products The Food and Drug Administration (FDA) requires drug establishments to furnish a current list of all pharmaceuticals that are made, prepared, propagated, compounded, or processed at their facilities and intended for sale in the United States.
  2. 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.

  1. However, this only applies if the outsourcing facility is also a drug compounding facility.
  2. 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.
  3. 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.

  1. The distribution of a product’s NDC number does not in any way signify that the product has been approved by the FDA.
  2. 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.
  3. 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).

  1. 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.
  2. 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.

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What does an NDC tell you?

Search NDC – What Is the National Drug Code Directory and What Is the NDC Number? A registered drug establishment is required to provide the Food and Drug Administration (FDA) with an up-to-date list of all of the drugs that it has manufactured, prepared, propagated, compounded, or processed for commercial distribution in accordance with Section 510 of the Federal Food, Drug, and Cosmetic Act (Act), which can be found in 21 United States Code Section 360.

The Food and Drug Administration Amendments Act of 2007 (Public Law 110-85) (FDAAA) brought about changes to the Act that require information regarding drug establishment registration and drug listing to be submitted electronically, unless a waiver is granted. The FDAAA was passed as Public Law 110-85 in 2007.

A three-segmented, one-of-a-kind number that is used to identify and report drug items is known as the National Drug Code (NDC). This number serves as a universal product identification for medications intended for human consumption. In order to complete the listing process, the FDA enters the whole NDC number as well as the information that was provided into a database known as the Drug Registration and Listing System (DRLS).

  • This database is now being converted into an electronic system (eDRLS).
  • The information that is given as part of the listing procedure, including the NDC number, DRLS, eDRLS, and the NDC Directory, is utilized in the process of putting the Act into effect and enforcing it.
  • In accordance with section 207.30 of Title 21 of the Code of Federal Regulations, a registered establishment is required to conduct a drug listing data update twice yearly, in the months of June and December, in order to identify drugs that had not been previously listed or when a change takes place.

Before updating the NDC Directory, in certain instances FDA might not have been aware of recent changes. The FDA takes every effort to ensure that the data in the NDC Directory are free of errors and inconsistencies. Food and Drug Administration Office of Compliance New Hampshire Ave.

Silver Spring, Maryland 20903 Internet email: [email protected] hhs. gov Users are asked to notify the Food and Drug Administration if they find any problems on the website. Which items may be found in the NDC Directory’s database? The current version of the NDC Directory is restricted to prescription drugs, over-the-counter drugs, and insulin products that have been manufactured, prepared, propagated, compounded, or processed for commercial distribution by registered establishments.

This includes drugs that are available with or without a doctor’s prescription. The provisions of the Drug Listing Act and regulatory provisions for the submission of drug product information to FDA have been adhered to in order for the items to be included on the list.

Why aren’t some pharmaceutical goods listed in the NDC Directory? It’s possible for a drug product to be absent from the NDC Directory for a variety of reasons, including the following: The company has informed the FDA that the product is no longer being marketed; the company has not complied fully with its listing obligations, and as a result, its product is not included until complete information is provided.

the product may not be a prescription drug, an over-the-counter drug, or an insulin product; the company has informed the FDA that the product is no longer being marketed. INCLUSION OF A COMPANY OR ITS PRODUCTS IN THE NDC DIRECTORY DOES NOT INDICATE APPROVAL BY THE FDA OF THE COMPANY OR ANY OF ITS MARKETED PRODUCTS, NOR DOES IT INDICATE A DETERMINATION THAT A PRODUCT IS A DRUG AS DEFINED BY THE ACT, NOR DOES IT INDICATE THAT A PRODUCT IS COVERED BY OR ELIG How are the Listings in the NDC Directory Arranged? 1.

Brand Name of the Product or Its Catalogue Name According to the requirements of the Act, the manufacturer is the one who, in most cases, supplies the names of the products that are used in the NDC Directory. Manufacturers are also referred to as “labelers” or “firms” for the purposes of listing. The NDC Directory places a maximum character count of 100 on any and all product names that appear in the directory.

Modifications of a less significant editorial nature were made in several instances when information that is typically provided with the name appeared elsewhere in the product description. For instance, in situations in which the term “strength” would typically be included as a component of the product name, but would also exist in other data fields, the term “strength” may have been omitted from the product name.

  • It’s possible that the labels “United States Pharmacopeia” (USP) and “National Formulary” (NF) have been removed from product names as well.
  • But it’s possible that the phrases “not NF” and “not USP” were left in there as a component of the name.
  • Because of the capability of the computer input, any symbols that indicated registered or trademarked items were likewise left out.

However, the intention of these deletions is not to violate any laws or regulations pertaining to copyright, patents, trademarks, or registrations.2. National Medication Code Each every drug product on the National Drug Code is given its own own 10-digit, 3-segment code.

  1. This number, which is referred to as the National Drug Code (NDC), is used to identify the labeler, product, and trade package size.
  2. The Food and Drug Administration will provide you with the first part, which is the labeler code.
  3. A company is considered to be a labeler if it either manufactures the medicine (which includes repackers and relabelers) or distributes it (under its own name).

The second piece of information, known as the product code, identifies a particular company’s product in terms of its dosage form, formulation, and strength. The third section, known as the package code, is responsible for identifying the various sizes and types of packages.

The company is responsible for assigning the codes for the goods as well as the packaging. The NDC will either be in the following configurations or one of its own: 4-4-2, 5-3-2, or 5-4-1. Due to the fact that the NDC may only have a maximum of 10 digits, a company that has a labeler code with only 5 digits is required to choose between having a product code with 3 digits and a package code with 2 digits, or having a product code with 4 digits and a package code with 1 digit.

Therefore, the three parts of the NDC can be organized in either a 5-4-1 or a 5-3-2 format, depending on your preference. Many applications may pad the product code or package code portions of the NDC with a leading zero rather than the asterisk since this conflicts with the HIPAA requirement of an 11-digit NDC.

Because a zero is considered to be a legitimate digit in the NDC, this might cause difficulties when trying to reassemble the NDC according to the FDA standard. For example, the 11-digit number 12345-0678-09 might be written as either 12345-678-09 or 12345-0678-9, depending on the setting of the company.3.

Dosage Form The full list of dosage form codes may be found in the downloaded file called TBLDOSAG.TXT, which can be seen below.4. The Different Methods of Administration The full set of codes for the various routes of administration may be found in the downloaded file that can be found below.

  1. TBLROUTE. TXT.5.
  2. The Ingredient in Question (s) FORMULAT.
  3. TXT is a distinct file that contains a listing of the active components.
  4. This file is related to LISTINGS.
  5. TXT by the LISTINGS SEQ NO field, which is present in both files.6.
  6. Strength After the name of the active component, the strength of the medicine is listed.
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The potency that is stated for items that include chemicals that are comparable to one another is that of the equivalent. When it comes to some combination goods, the strength is the one that is generally accepted for the composition in question. Additionally, there is a strength or unit associated with the product itself.

  1. When referring to a product that contains only one active component, the given strength refers to the concentration of that single component.
  2. When referring to items that include more than one active component, the strength designation will either be “COMBO” or a concatenation of the several strengths.7.

Unit TBLUNIT.TXT contains the comprehensive collection of acronyms for units together with their respective meanings.8. Package Size and Type The company submitted the packaging sizes and kinds, therefore those details are included in the NDC Directory.9.

  1. Principal Types of Drugs These codes for the Major and Minor Drug Class are no longer accessible through this website.
  2. The FDA has it on their agenda to investigate the use of the AMA DRUG Evaluation Subscription categorization system.
  3. This categorization method has not been revised since 1976, and as a result, many new molecular entities have not been accounted for in this review.

As a result of this, this review is essential.10. the application number that has been authorized by the FDA A number in this field is the NDA/ANDA number, which indicates that this product has been approved by the FDA for marketing based upon a review of the safety and effectiveness of the drug, including review of 1) whether adequate and well-controlled investigations show that this drug is safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling; 2) the methods used in, and the facilities and controls used for, the manufacture, production, and distribution of the product; and 3) the facilities and controls used for the manufacture Look at section 505 of the Act or section 355 of the 21st United States Code for further information on the approval of NDAs and ANDAs.

  • You can have access to further information about drug items and application holders by utilizing the NDA/ANDA number.
  • This information is contained within the FDA Orange Book.
  • ‘OTHER’ in this field indicates that this product may not be approved for both safety and efficacy under an NDA or ANDA, may be subject to the Drug Efficacy Study Implementation (DESI), and/or may be one for which the FDA currently lacks sufficient data to provide information.

In addition, this product may be one for which the FDA currently lacks sufficient data to provide information. DESI is a retrospective examination of the efficacy of medications that had been authorized on safety grounds alone between 1938 and 1962, as well as pharmaceuticals that are same, related, or similar to those drugs.

  1. This study was conducted by the Drug Evaluation and Safety Initiative (DESI).
  2. In 1962, revisions were made to the FD&C Act, which introduced the need that a medicine be examined for efficacy in order for the FDA to approve it.
  3. These amendments made it necessary for this evaluation to take place because of this requirement.

Requests for information that is more specific should be made in writing and sent to the Food and Drug Administration’s Freedom of Information Staff at the following address: Food and Drug Administration Freedom of Information Office, New Hampshire Ave.

National Drug Code Directory Support Files
Filename Description
tbldosag. txt tblroute. txt tblunit. txt The Directory contains 3 tables that list descriptors and codes describing the data. They are: Dosage Forms, Routes of administration, and Unit Codes.

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National Drug Code Directory ASCII Data Files The 11 data files contain the product and firm data. The files have one or both linking elements: LISTING_SEQ_NO NOT NULL NUM(7) FDA generated unique identification number for each product. Only used in information systems to link tables together; not used publicly. LBLCODE NOT NULL NUM(7) FDA generated identification number for each firm. Used as the first segment in the NDC and can be used to link tables together based on Firm. Filename Description 1. LISTINGS DATA EACH PRODUCT HAS A UNIQUE LISTING SEQ NO; EACH FIRM SEQ NO CAN HAVE MULTIPLE LISTING SEQ NO’S. Each line in this file represents a product for an individual firm. The listing includes such information as the product’s name, firm’s seq number, dose form(s), and Rx/OTC. LISTING_SEQ_NO NOT NULL NUM(7) COL: 1-7 FDA generated unique identification number for each product. LBLCODE NOT NULL CHAR(6) COL: 9-14 Labeler code portion of NDC; assigned by FDA to firm. The labeler code is the first segment of the National Drug Code. While always displayed as 6 digits in this file; for labeler codes 2 through 9999, some systems display it as 4 digits; for labeler codes 10,000 through 99,999 it is 5 digits. Can be used to link to the FIRMS. TXT file to obtain firm name. PRODCODE NOT NULL CHAR(4) COL: 16-19 Product code assigned by firm. The prodcode is the second segment of the National Drug Code. It may be a 3-digit or 4-digit code depending upon the NDC configuration selected by the firm. STRENGTH NULL CHAR(10) COL: 21-30 For single entity products, this is the potency of the active ingredient. For combination products, it may be null or a number or combination of numbers, e.g. , Inderide 40/25. UNIT NULL CHAR(10) COL: 32-41 Unit of measure corresponding to strength. This non-mandatory field contains the unit code for a single entity product, e.g. , MG, %VV. RX_OTC NOT NULL CHAR(1) COL: 43 Indicates whether product is labeled for Rx or OTC use (R/O). TRADENAME NOT NULL CHAR(100) COL: 45-144 Product’s name as it appears on the labeling. 2. PACKAGES DATA MAY OCCUR MULTIPLE TIMES PER LISTING SEQ NO Stores packages for an individual listing. The packages table includes all packages for a corresponding listing. The PKGCODE field contains the last one or two digit segment of the NDC. LISTING_SEQ_NO NOT NULL NUM(7) COL: 1-7 Linking field to LISTINGS. PKGCODE NULL CHAR(2) COL: 9-10 The package code portion of NDC code. The package code is the last segment of the NDC. PACKSIZE NOT NULL CHAR(25) COL: 12-36 The unit or number of units which make up a package. PACKTYPE NOT NULL CHAR(25) COL: 38-62 Package type, i.e. , box, bottle, vial, plastic, or glass. 3. FORMULATIONS DATA MAY OCCUR MULTIPLE TIMES PER LISTING SEQ NO. Lists active ingredients contained in product’s formulation. LISTING_SEQ_NO NOT NULL NUM(7) COL: 1-7 Linking field to LISTINGS. STRENGTH NULL CHAR(10) COL: 9-18 This is the potency of the active ingredient. UNIT NULL CHAR(5) COL: 20-24 Unit of measure corresponding to strength. INGREDIENT_NAME NOT NULL CHAR(100) COL: 26-125 Truncated preferred term for the active ingredient. 4. NEW DRUG APPLICATION DATA MAY OCCUR MORE THAN ONCE PER LISTING SEQ NO. LISTING_SEQ_NO NOT NULL NUM(7) COL:1-7 Linking field to LISTINGS. APPL_NO NULL CHAR(6) COL:9-14 Number of New Drug Application if applicable. If none has been provided by the firm then the value ‘Other’ is used. PROD_NO NULL CHAR(3) COL:16-18 Number used to identify the products of a New Drug Application. 5. FIRM NAME DATA EACH FIRM HAS A UNIQUE FIRM SEQ NO WHICH CAN OCCUR MULTIPLE TIMES IN THE LISTINGS FILE. Contains the firm’s full name, and compliance address. The compliance address is the mailing address where the FDA sends listing information to the firm. LBLCODE NOT NULL NUM(6) COL:1-6 FDA generated identification number for each firm. The number is padded to the left with zeroes to fill out to length 6. FIRM_NAME NOT NULL CHAR(65) COL:8-72 Firm name as reported by the firm. ADDR_HEADER NULL CHAR(40) COL:74-113 Address Heading as reported by the firm. STREET NULL CHAR(40) COL:115-154 Street Address as reported by firm. PO_BOX NULL CHAR(9) COL:156-164 Post office box number as reported by firm. FOREIGN_ADDR NULL CHAR(40) COL:166-205 Address information report by firm for foreign countries that does not fit the U.S. Postal service configuration. CITY NULL CHAR(30) COL:207-236 STATE NULL CHAR(2) COL:238-239 ZIP NULL CHAR(9) COL:241-249 USPS Zip code. PROVINCE NULL CHAR(30) COL:251-280 Province of Foreign country if appropriate. COUNTRY_NAME NOT NULL CHAR(40) COL:282-321 6. ROUTE OF ADMINISTRATION DATA LISTING_SEQ_NO NOT NULL NUM(7) COL:1-7 Linking field to LISTINGS. ROUTE_CODE NULL CHAR(3) COL:9-11 The code for the route of administration. File will allow all assigned values for this element. ROUTE_NAME NULL CHAR(240) COL:13-252 The translation for the route of administration code. 7. DOSAGE FORM MAY OCCUR MULTIPLE TIMES PER LISTING SEQ NO. LISTING_SEQ_NO NOT NULL NUM(7) COL:1-7 Linking field to LISTINGS. DOSEFORM NULL CHAR(3) COL:9-11 The code for the route of administration. File will allow all assigned values for this element. DOSAGE_NAME NULL CHAR(240) COL:13-252 The translation for the route of administration code. 8. TBLDOSAG. TXT THIS FILE CONTAINS A COMPLETE LIST OF THE DOSAGEFORM CODES USED IN THE DIRECTORY DOSEFORM CHAR(3) COL:1-3 The code for the dosage form. TRANSLATION CHAR(100) COL:5-104 The translation for the DOSAGE FORM code. 9. TBLROUTE. TXT THIS FILE CONTAINS A COMPLETE LIST OF THE ROUTE CODES USED IN THE DIRECTORY ROUTE CHAR(3) COL:1-3 The code for the ROUTE OF ADMINISTRATION. TRANSLATION CHAR(100) COL:5-104 The translation for the ROUTE code. 10. TBLUNIT. txt THIS FILE CONTAINS A COMPLETE LIST OF THE POTENCY UNIT ABBREVIATIONS USED IN THE DIRECTORY. UNIT CHAR(15) COL:1-15 The potency unit abbreviations used in the directory. TRANSLATION CHAR(100) COL:17-115 The translation for the UNIT abbreviations. 11. REG_SITES. txt This file contains a list of all currently active and registered domestic manufacturing facilities. UNLIKE THE FILES ABOVE, IT IS A TAB DELIMITED FILE, WITH THE FIRST LINE CONTAINING THE COLUMN HEADERS. The data elements are: FEI: Unique ID number LAST_REG_YEAR: Last year the annual registration obligation was fulfilled. Some older, inactive sites may be on the list. The records need to be updated by the firm and/or FDA. NAME: Registered firm name STREET: street address CITY: name of city STATE: name of state ISO_COUNTRY_CODE: identifies the country. Currently only U.S. sites are included. COUNTRY_NAME: translation of country code. 12. SCHEDULE. txt This file identifies those listed products in the directory which have a DEA schedule designation. LISTING_SEQ_NO NOT NULL NUM(7) COL:1-7 Linking field to LISTINGS. SCHEDULE NOT NULL NUM(1) COL:9 13. ZIPPED NDC DIRECTORY DATA NDC text data files
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How do I find the NDC number for a drug?

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. You could also see anything that says “NDC Item Code (source)” within the results of your search. This is a reference to the NDC code that was printed on the product’s original packaging.

How long is an NDC number?

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).

How many unique 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 codes 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).

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