NDC Number — NDC Labeler Code Assignment
The National Drug Code (NDC) labeler code is required for all drug establishments and private label distributors before listing drug products with FDA. LMG handles the full NDC labeler code request and assignment process.
NDC Number and FDA Labeler Code
What Is a Labeler Code?
The FDA labeler code is a unique number assigned by the FDA to the “labeler.” The labeler is typically the company that manufactures the product, owns the brand, or holds the drug application. The labeler code forms the first segment of every National Drug Code (NDC) assigned to drug products marketed by that company.
A labeler code is not location-specific. A company is not required to obtain a different labeler code for each manufacturing establishment under the same ownership, since the labeler code identifies a company, not a physical site.
What Is an NDC Number?
The National Drug Code (NDC) is the unique identifier assigned to every drug product marketed in the United States. The NDC is a three-segment number in which:
Segment 1 (Labeler Code) — identifies the labeler (company). Assigned by FDA.
Segment 2 (Product Code) — identifies the specific drug product (strength, dosage form, formulation). Assigned by the labeler.
Segment 3 (Package Code) — identifies the package type and size. Assigned by the labeler.
Important Update: NDC Transitioning to 12-Digit Format
The FDA published a final rule on March 5, 2026, standardizing the NDC to a single uniform 12-digit format. Effective March 7, 2033, all FDA-assigned NDCs will follow a single 6-4-2 format — a 6-digit labeler code, 4-digit product code, and 2-digit package code — totaling 12 digits. Existing 10-digit NDCs will be converted by adding leading zeros.
Under the current system, the FDA assigns 10-digit NDCs in multiple configurations (5-3-2, 5-4-1, 4-4-2). The transition to a single 12-digit format is intended to eliminate the conversion friction across healthcare systems. Key transition dates:
March 7, 2033 — Effective date. FDA begins assigning 12-digit NDCs; existing 10-digit NDCs auto-convert with leading zeros.
March 2033–March 2036 — Transition period. 10-digit labeling is tolerated; systems must handle both formats.
After March 2036 — Enforcement action is possible for non-compliant labeling.
FDA will automatically update all drug listing SPL files to show the 12-digit NDC format on the effective date. Drug manufacturers will not need to resubmit or update their listings for the new NDC format. However, labeling, packaging, barcodes, and IT systems will need to be updated before the effective date.
Example of NDC Number Assignment
Consider a labeler code assignment for a sunscreen product: 12345 — 101 — 50
12345 = Labeler code (identifies XYZ Company, assigned by FDA)
101 = Product code (identifies the drug — Sunscreen with Zinc Oxide 20%, assigned by the labeler)
50 = Package code (identifies the package type and size — 50 ml tube, assigned by the labeler)
Under the new 12-digit format (effective 2033), the same NDC would appear as 012345 — 0101 — 50 (labeler code expanded to 6 digits, product code to 4 digits).
Who Needs a Labeler Code?
All registered establishments must list all drugs they produce for U.S. commercial distribution under their own labeler code. This includes active pharmaceutical ingredient manufacturers, other bulk drug manufacturers, contract manufacturers, repackers, and relabelers.
Private Label Distributors (PLDs) are not required to register their establishment with FDA; however, they must apply for their own labeler code and list their drugs with FDA.
Under most circumstances, an assigned labeler code that does not have any NDCs listed with FDA within two years will be deactivated. You must maintain at least one active drug listing to keep your labeler code active.
What NDC Entry in the FDA Directory Does Not Mean
It is important to understand what an NDC number does not represent. Entry in the NDC directory does not indicate that the FDA approved or verified the information of the drug. Assignment of an NDC number to non-drug products is strictly prohibited. Under the FD&C Act, registration of a drug establishment or assignment of an NDC number does not denote FDA approval of the company or its products.
How to Get an NDC Labeler Code
To obtain an NDC labeler code, the labeler must prepare and submit a Labeler Code Request SPL (Structured Product Labeling) file to the FDA. The submission must include the labeler name, DUNS number, contact information, and US agent information (for foreign companies). The labeler code SPL document must include all necessary data — such as the name and DUNS number of the company and contact information of someone responsible for receiving FDA communications related to drug listings with NDCs under that labeler code.
FDA will not accept submissions in paper format or via email. The labeler code request must be submitted electronically via the FDA Electronic Submission Gateway (ESG) or the CDER Direct Portal.
Once FDA assigns the labeler code, the labeler must reopen the original SPL file, add the assigned code, and resubmit to complete the process.
LMG assists labelers with the full process — SPL file preparation, DUNS number guidance, US FDA agent service, Submission via ESG, and follow-up until the labeler code is confirmed.
NDC Number Assistance
LMG manages the complete NDC labeler code request — from initial assignment through product-level NDC number structure.
NDC Labeler Code Request
We prepare and submit your NDC labeler code request to FDA — the first step required before any drug products can be listed in the FDA drug database.
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NDC Labeler Code Assignment
After receiving the labeler code request, FDA assigns the Labeler code. LMG then resubmits the SPL with your assigned NDC code to complete the process.
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Drug Listing Submission
After receiving your labeler code, we assist with full drug listing submissions including NDC product codes, labeling, and SPL data.
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NDC Labeler Code Reservation
LMG reserves your NDC to prevent duplication and formatting conflicts — giving you a confirmed, validated code ready for product launch.
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How It Works
Frequently Asked Questions
What is an NDC labeler code?
The NDC labeler code is the first 4 or 5 digits of the National Drug Code — assigned by FDA to each labeler. It uniquely identifies your company as the labeler of the drug product.
Is an NDC labeler code required?
Yes. Any establishment that wishes to list drug products with the FDA must first obtain an NDC labeler code.
Is there a government fee for the NDC labeler code?
No. FDA does not charge a fee for NDC labeler code assignment. There is no government fee — only LMG’s professional service fee.
How long does it take to get an NDC labeler code?
FDA typically assigns NDC labeler codes within 1–2 business days of a complete labeler code request submission.
Need Your NDC Labeler Code?
LMG handles the full drug registration and NDC labeler code assignment process — fast, accurate, and affordable.
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