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  4. Electronic Drug Registration and Listing System (eDRLS)
  5. Drug Registration and Listing Instructions
  6. How to Reserve a National Drug Code
  1. Drug Registration and Listing Instructions

How to Reserve a National Drug Code

Reserving a national drug code is an optional step that provides an NDC up to two years before a drug is ready to launch. There are two main benefits:

  • If the drug launch is coming, an entity can secure an NDC early without having to complete a full drug listing submission right away.
  • Contract manufacturers can reserve an NDC for a private label distributor’s drug before printing labels to avoid costly reprints if a number is unavailable later.

Important things to know

  • Reserving an NDC is not the same as listing a drug. The drug is not considered listed with FDA while the NDC is reserved.
  • An entity has two years to convert an NDC reservation into a full drug listing. Otherwise, the NDC will be released and made available for another drug.
  • If an entity reserves multiple NDCs in one submission, all NDCs must be converted to active listings when a reservation switches to a listed submission.
  • FDA will automatically update a reserved NDC to the new 12-digit format when the NDC format final rule takes effect on March 7, 2033.

Visit national drug code format for more information about FDA’s final rule adopting a uniform 12-digit NDC.

Steps to reserve an NDC

To submit an initial reservation for an NDC:

  • If you are not already assigned a labeler code by FDA, request a labeler code
  • Create an NDC Reservation structured product labeling (SPL)
  • Select the appropriate document type (human prescription drug, human over-the-counter/nonprescription drugs, etc.)
  • Complete all the required data elements. All NDC reservation SPL documents must have:
  • NDC labeler code and proposed product code
  • Drug’s non-proprietary name
  • In the case of finished drug, dosage form and route of administration
  • At least one active ingredient, with ingredient name, unique ingredient identifier, strength, active moiety and basis of strength
  • Marketing status should be set to “new”
  • Reserved until date field will auto populate
  • Characteristics based on dosage form
  • Submit SPL

Visit instructions for completing an NDC reservation using FDA Direct (page three) for more information.

Canceling a reserved NDC

A reserved NDC should be canceled if the drug will not enter U.S. commercial distribution within two years as previously planned.

To cancel a reserved NDC:

  • Create a copy/new version of the most recent submission
  • Do not change the set ID
  • Generate a new document ID/root ID
  • Enter an appropriate effective date and version number (generally, one number higher than the previous submission)
  • Change the marketing status to canceled
  • Submit SPL

Visit Instructions to cancel an NDC reservation using FDA Direct (page 11) for more information.

Converting an NDC reservation to drug listing

To convert an NDC reservation SPL to a listing SPL:

  • Create a copy/new version of the most recent submission
  • Do not change the set ID
  • Generate a new document ID/root ID
  • Enter an appropriate effective date and version number
  • Select the NDC under the products section
  • Change the marketing status to active
  • Enter in the start marketing date
  • Complete all required data elements for an active drug listing
  • Submit SPL

Visit instructions for converting an NDC reservation to an active listing using FDA Direct (page 15) for more information.

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