NDC Numbers: Not a Guarantee of FDA Approval

A common misconception that pharmacies have is that if a product has an NDC (National Drug Code) number that means it is approved by the FDA – unfortunately, this is not the case.

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In fact, the FDA does not assign the NDC number. The company making a product must register with the FDA to obtain a “labeler code” (the first set of numbers in the NDC); these companies may be the manufacturer, a repackager or a distributor. Once they have obtained a labeler code, the company then assigns the product code (middle set of numbers in the NDC) and the package code (the last set of numbers in the NDC) and submits the final NDC to the FDA to have their product added to FDA’s NDC SPL Data Elements File (NSDE).

Products billed to Medicare and/or Medicaid that are not FDA approved are subject to recoupment. Examples include:

  • Unapproved drug other (example Anucort-HC Rectal Suppository NDC 00713-0503-12)
  • Dietary supplements – (example WellPro 31 NDC 71741-0376-30)

PAAS Tips:

  • Do not assume that a product is “FDA approved” just because it has an NDC number
  • Medicare gives preference to a “pay and chase” model when it comes to claims – they want beneficiaries to receive needed medications and will pay the claim at point-of-sale assuming the medication is being used in an FDA approved manner
  • Caremark prohibits the use of ANY coupon for non-FDA approved products
    • As defined in the current Provider Manual: “Pharmaceutical Manufacturer Coupon” means any item or mechanism, including but not limited to, paper coupons, copay cards, e-vouchers, mail-in rebates, and electronic coupon codes funded by a manufacturer, repackager, or supplier of pharmaceutical, chemical, or compounding products, that reduces the portion of the Patient Pay Amount that an Eligible Person is required to pay for a Covered Item
  • Be cautious about billing products that are not FDA approved
  • Consider checking the following to determine FDA approval and marketing status
    • Your wholesaler database
    • Your software vendor drug file
    • FDA Orange Book: https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm
    • FDA Purple Book: https://purplebooksearch.fda.gov/
    • DailyMed: https://dailymed.nlm.nih.gov/dailymed/index.cfm
    • NSDE: https://www.fda.gov/industry/structured-product-labeling-resources/nsde
  • The FDA states the following regarding the NDC (National Drug Code) Database:
    • “The inclusion of a firm or its products in the NDC directory does not denote approval by the FDA of the firm or any of its marketed products, nor is it a determination that a product is a drug as defined by the act, nor does it denote that a product is covered by or eligible for reimbursement by Medicare, Medicaid, or other payers.”
  • If you are ever in doubt about a product, call PAAS at (608) 873-1342 so that we can help you identify whether it may be a problem

Jennifer Ottman, CPhT