National Drug Codes Explained: What You Need to Know (2024)

Medically reviewed by Leigh Ann Anderson, PharmD. Last updated on June 12, 2024.

What is a National Drug Code (NDC)?

The NDC, or National Drug Code, is a unique 10-digit or 11-digit, 3-segment number, and a universal product identifier for human drugs in the United States.

The 3 segments of the NDC identify: the labeler, the product, and the commercial package size.

  • The first set of numbers in the NDC identifies the labeler, such as the drug manufacturer, repackager, or distributer.
  • The second set of numbers is the product code, which identifies the specific strength, dosage form (i.e, capsule, tablet, liquid) and formulation of a drug for a specific labeler.
  • The third set of numbers is the package code, which identifies package sizes and types.

The labeler code is assigned by the U.S. Food and Drug Administration (FDA), while the product and package code are assigned by the labeler. For billing or other purposes, such as with the Centers for Medicare & Medicaid Services (CMS), an NDC may also be arranged in an 11-digit format with leading zeros, if needed.

The NDC Directory contains information on all finished and unfinished prescription medications, over-the-counter (OTC) medicationsand compounded drug products in the U.S. FDA publishes the listed 10-digit NDC numbers and the information submitted as part of the listing information in the NDC Directory which is updated daily.

As of June 1, 2011, only drugs for which electronic listings (Structured Product Labeling or SPL) have been submitted to FDA are included in the NDC Directory. Animal drugs, blood products, or human drugs, among others, that are not in final marketed form are not included in the NDC directory.

How is the NDC formatted?

The 10-digit NDC will be in one of the following configurations: 4-4-2, 5-3-2, or 5-4-1, meaning that there are 4 or 5 digits for the labeler code, 4 or 3 digits for the product code and 2 or 1 digit(s) for the package code.

Example NDC

National Drug Codes Explained: What You Need to Know (1)

For example, the NDC for a 100-count bottle of Prozac 20 mg is 0777-3105-02.

The first segment identifies the labeler (the labeler code "0777" is for Dista Products Co., the labeler of Prozac).

The second segment, the product code, identifies the strength, dosage form (i.e, capsule, tablet, liquid) and drug formulation for a specific labeler ("3105" identifies that this dosage form is a capsule).

The third segment is the package code, and it identifies package sizes and types. The package code "02" for this bottle of Prozac identifies that 100 capsules are in the bottle.

Where can I find an NDC number for a drug?

  • You can easily use the Drugs.com Pill Identification Wizard to identify medications by NDC number. You can also access NDC numbers via the free Drugs.com Medication Guide App.
  • The FDA also maintains a searchable database of NDC codes on their website. NDC numbers can also be found in the drug product labeling (for example, the package insert) as well as on the package itself.

Why are some drug products not in the NDC Directory?

According to the FDA, reasons why a drug product may not appear in the NDC Directory, include:

  • the product may not be a prescription drug, OTC, or an insulin product.
  • the firm has notified the FDA that the product is no longer commercially available and marketed.
  • The manufacturer has not provided a complete listing of the drug product.

The FDA requires that drug establishment registration and drug listing information be submitted electronically unless a waiver is granted.

Outsourcing facilities (a type of drug compounding facility) may, but are not required to, assign NDCs to their finished compounded human drug products. Instead, they provide FDA with a list of compounded drugs twice per year.

Why do some NDC numbers have 11 digits?

For certain purposes, including the proper billing of drug products, an 11-digit NDC may be required. The Centers for Medicare & Medicaid Services (CMS) and other government entities require an NDC as part of their billing claim form. Some government agencies, including HIPAA, may require the NDC in an 11-digit format (a 5-4-2 format) with leading zeros. Increasingly, private payors are requiring the 11-digit code, but rules can vary greatly.

  • The CMS NDC identifier is formatted as 11 digits with no spaces, hyphens or other characters.
  • If the NDC Package code is less than 11 digits (for example, a 4-4-2 structure) the code must be padded with leading zeros.
  • The leading zero is added to the needed section to create a 5-4-2 configuration.

NDC numbers have also appeared with an asterisk in either a product code or a package code. The asterisk acts as a placeholder and indicates the configuration of the NDC.

Per the FDA, because of a conflict with the HIPAA standard of an 11-digit NDC, many programs will pad the product code or package code segments of the NDC with a leading zero instead of an asterisk. However, the FDA states asterisks are no longer used or included within the product file data elements to indicate certain configurations of the NDC.

Since a zero can be a valid digit in the NDC, this can lead to confusion when trying to return the 11-digit NDC back to its 10-digit FDA standard. For example, as noted by the FDA, 12345-0678-09 (11 digits) could be 12345-678-09 or 12345-0678-9 depending on the firm's configuration.

How do you convert a 10-digit NDC to an 11-digit NDC?

Increasingly, payors are requiring an 11-digit NDC code for billing purposes. Therefore, proper billing may require a specially-placed zero to create a 5-4-2 format depending upon the drug product’s 10-digit NDC.

10-Digit to 11-Digit NDC Conversion Example

10-digit format (on package)10-digit format (segment format)Converted 11-digit format (with zero added)11-digit format example (for billing purposes)
Table 1: Adapted from Maryland Dept. of Health (www.maryland.gov); FDA National Drug Code Directory
9999-9999-994-4-209999-999-995-4-2
99999-999-995-3-299999-0999-995-4-2
99999-9999-95-4-199999-9999-095-4-2

How are NDC numbers used for billing purposes?

When submitting a claim for reimbursement, it is always best to check with the payor(s) to determine the specifics for NDC coding and reimbursement, as rules vary widely.

According to the American Academy of Pediatrics (AAP), many payors like Blue Cross and Blue Shield, Tricare, and state Medicaid plans have guidance on how they want NDC codes to be used. In addition, some Medicaid plans exclude the use of NDC codes for vaccines.

When will 10-digit NDC numbers run out?

The FDA states that the 5-digit format provides 90,000 potential combinations but expects to run out of labeler codes by roughly 2033 or even sooner. The COVID-19 pandemic greatly increased the rate at which NDC codes were issued.

Are there 12-digit NCD numbers?

The FDA has proposed a rule for a single, universal 12-digit NDC with one uniform format.

On July 22, 2022 the FDA announced the availability of a proposed rule "Revising the National Drug Code Format and Drug Label Barcode Requirements" (Docket No. FDA-2021-N-1351). The goal is to minimize the impact of FDA running out of ten-digit national drug codes (NDCs) by adopting a single, uniform 12-digit format for FDA-assigned NDCs. FDA is proposing to change the NDC to 12 digits in length with 3 distinct segments and one uniform format.

Under the proposed FDA rule, the NDC would remain a three-segment numerical code consisting of the labeler code (6 digits), the product code (4 digits), and the package code (2 digits) in a single, universal 6-4-2 format (12 digits total). If this rule is finalized, the proposed standardized format would facilitate the adoption of a single NDC format by all stakeholders instead of needing to convert NDCs for payor submission or other uses.

Sources

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

National Drug Codes Explained: What You Need to Know (2024)

FAQs

National Drug Codes Explained: What You Need to Know? ›

The first five digits indicate the manufacturer or the labeler; the next four digits indicate the ingredient, strength, dosage form and route of administration; and the last two digits indicate the packaging. The FDA assigns the manufacturer portion of the code; the manufacturer supplies the rest.

What are National Drug Code standards? ›

The NDC, or National Drug Code, is a unique 10-digit, 3-segment number. It is a universal product identifier for human drugs in the United States. The code is present on all nonprescription (OTC) and prescription medication packages and inserts in the US.

What are the rules for NDC? ›

Proper billing of an NDC requires an 11-digit number in a 5-4-2 format. Converting NDCs requires a stregically placed zero, depending on the 10-digit format. The following table shows common 10-digit NDC formats indicated on packaging and the appropriate conversion to an 11-digit format.

What is the importance of the National Drug Code number? ›

The NDC number is important to healthcare because it provides complete transparency regarding the drug name, manufacturer, strength, dosage, and package size. Additionally, the NDC is very important in the hospital billing system.

What is the hierarchy of NDC codes? ›

NDC codes exist in one of the following groupings of digits into segments: 4-4-2, 5-3-2, 5-4-1, 6-3-2, or 6-4-1. The following NDC structure rules apply depending on the length of certain segments. These rules include the 11 digit format. Unless stated otherwise, search for drug codes using the 10 digit format.

How do you read the National Drug Code? ›

The first five digits indicate the manufacturer or the labeler; the next four digits indicate the ingredient, strength, dosage form and route of administration; and the last two digits indicate the packaging. The FDA assigns the manufacturer portion of the code; the manufacturer supplies the rest.

What are the three parts of the NDC number? ›

The 3 segments of the NDC identify: the labeler, the product, and the commercial package size. The first set of numbers in the NDC identifies the labeler, such as the drug manufacturer, repackager, or distributer.

How does an NDC work? ›

An NDA requires the recipient to take reasonable measures to keep the information confidential and prohibits each recipient from disclosing it to any unauthorized party. This way, your information is only used by those who you want to use it, and then only for the purposes you want it used for.

Can two drugs have the same NDC? ›

Historically, the Food and Drug Administration (FDA) permitted the reuse of an NDC if the product had been discontinued for at least five years. However, FDA regulations1, effective November 29, 2016, prohibit the reuse of an NDC if the NDC was previously assigned to a different drug.

How is an NDC code assigned? ›

The first segment, the labeler code, is assigned by the FDA. A labeler is any firm that manufactures (including repackers or relabelers), or distributes (under its own name) the drug. The second segment, the product code, identifies a specific strength, dosage form, and formulation for a particular firm.

What is an invalid NDC code? ›

An invalid and or non-covered NDC code on the first line will cause the entire claim to deny. Invalid NDC codes: If the NDC code on each line does not follow the standard NDC format (i.e. typo) the entire claim will deny even if the first line contains a valid/covered NDC code.

Which law required each drug be issued a National Drug Code? ›

Which law required each drug be issued a National Drug Code (NDC) that identifies the manufacturer, drug, strength, dosage form, and package size? The Drug Listing Act (1972).

What is the difference between NDC and UPC? ›

While both codes are used for product identification, they serve different purposes. UPCs are used for retail purposes, while NDC numbers are used specifically for prescription medications in the healthcare industry.

WHO issues NDC codes? ›

(1) An NDC is proposed for assignment by FDA when it is submitted for the first time with listing information in accordance with § 207.49 or § 207.53, as applicable.

What do the first 5 digits of the NDC code identify? ›

The NDC number consists of 11 digits, broken into 3 sections in a 5-4-2 format. The first 5 digits identify the labeler code representing the manufacturer of the drug and are assigned by the Food and Drug Administration (FDA). The next 4 digits identify the specific drug product and are assigned by the manufacturer.

What is NDC code format? ›

Proper billing of a National Drug Code (NDC) requires an 11-digit number in a 5-4-2 format. Converting National Drug Code (NDC) from a 10-digit to an 11-digit format requires a strategically placed zero, dependent upon the 10-digit format.

What is an example of NDC? ›

Example: 12345-0678-09 (11 digits) could be 12345-678-09 or 12345-0678-9 depending on the firm's configuration.

What is the National Drug Code on a claim? ›

The NDC number consists of 11 digits with hyphens separating the number into three segments in a 5-4-2 format (e.g., 12345-1234-12). The first five digits identify the manufacturer of the drug and are assigned by the U.S. Food and Drug Administration (FDA).

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