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Posts Tagged ‘NDC’

Deconstructing the NDC Number

In Uncategorized on April 8, 2011 at 9:09 pm

When you are asked by your billing department / billing company for an NDC number, do you just “google” it, and think – man, they could have done that!?!  Rest assured, they could not…  It is more complicated than a quick Google search!  This is important from a compliance perspective.  In fact, to ensure that the proper NDC number is provided, one must actually see the packaging materials of the drugs provided to the patient, for drugs may be manufactured and/or packaged by several different companies, and there are different NDC numbers, accordingly.   More specifically:

What IS the NDC?

The Drug Listing Act of 1972 required registered drug establishments to provide the Food and Drug Administration (FDA) with a current list of all drugs manufactured, prepared, propagated, compounded, or processed by it for commercial distribution. (See Section 510 of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. § 360)).  Such drug products are identified and reported using a unique, ten-digit, three-segment number, called the National Drug Code (NDC), which is a universal product identifier for human drugs.  More specifically, the NDC number identifies:

  • the labeler (in the 1st segment),
  • product (in the 2nd segment), and
  • trade package size (in the 3rd segment)

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 that 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: 4-4-2, 5-3-2, or 5-4-1.

An asterisk may appear in either a product code or a package code.  It simply acts as a place holder and indicates the configuration of the NDC.  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 5-4-1 or a 5-3-2 configuration for the three segments of the NDC.  Note that 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 the asterisk.  However, since a zero can be a valid digit in the NDC, this can lead to confusion when trying to reconstitute the NDC back to its FDA standard. Example: 12345-0678-09 (11 digits) could be 12345-678-09 or 12345-0678-9 depending on the firm’s configuration — use of the asterisk for the place holder would eliminate this confusion. 

If you no longer have the packaging materials which list the NDC number, then please access http://www.accessdata.fda.gov/scripts/cder/ndc/default.cfm, which is a searchable NDC database allowing the user to search by proprietary name, active ingredient, application number, NDC number or firm (manufacturer) name. 

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