Ndc number how many numbers

Who is required to submit an NDC drug listing? Manufactures Repacker or Relaber Each domestic facility must list each such drug regardless of whether the drug enters interstate commerce. Private label distributor How FDAbasics assist you with drug listing? NDC number format NDC number can be assigned in 5 or 5 format, which means you can assign either a 4 or 3 digit code product and 1 or 2 digit pack code. Let say your company has obtained as a labeler code. NDC number for your product X can be assigned as below; labeler code — Product code 89 -Pack code or labeler code — Product code 1 -Pack code You can choose any 3 or 4 digit number as product code and 1 or 2 digit code pack.

Quick Links Quick Link 1. Minor editorial changes were made in some cases when information normally included with the name appears elsewhere in the product description. For example, where strength is ordinarily listed as a component of the product name, but also appears in other data fields, the strength may have been removed from the product name. Symbols indicating trademarked or registered products also are omitted because of computer input capabilities.

But these deletions are not intended to contradict patent, trademark, registration, or copyright laws or regulations. NDC Number Each listed drug product listed is assigned a unique digit, 3-segment number. This number, known as the NDC, identifies the labeler, product, and trade package size. 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. The third segment, the package code, identifies package sizes and types. Both the product and package codes are assigned by the firm. The NDC will be in one of the following configurations: , , or Since the NDC is limited to 10 digits, a firm with a 5 digit labeler code must choose between a 3 digit product code and 2 digit package code, or a 4 digit product code and 1 digit package code.

Thus, you have either a or a configuration for the three segments of the NDC. Example: 11 digits could be or depending on the firm's configuration. Strength The drug strength is indicated after the active ingredient. For those products with equivalent ingredients, the strength expressed is that of the equivalent.

For some combination products, the strength is that which is commonly recognized for that formulation. For products with a single active ingredient, the indicated strength is the strength of that active ingredient. For multiple active ingredient products, the strength is either "COMBO" or a concatenation of the multiple strengths. This review is necessary because this classification scheme has not been updated since and therefore many new molecular entities are not included.

See the DRLS instructions for more information. See points of contact for drug registration and listing. Resources for Information Approved Drugs. Download NDC Express.