United States
Hong KongNDC numbers
A National Drug Code has three segments identifying the labeler, the product and the package size, under 21 CFR 207.33.
A small, precise topic that appears reliably because it is unambiguous and easy to test.
The three segments
| Segment | Identifies |
|---|---|
| First | The labeler - the firm that manufactures, repacks or distributes under its own name |
| Second | The product - the specific strength, dosage form and formulation |
| Third | The package - the size and type of packaging |
The structure is set out at 21 CFR 207.33.
Two NDCs sharing a labeler segment and differing in the product segment are different strengths or forms from the same firm. That is exactly the pair most likely to be confused on a shelf, which is why NDC checking is an error-prevention control and not just an inventory convenience.
What it is used for
- Identifying exactly which product was dispensed
- Billing and claims processing
- Recall handling, alongside the lot number
- Inventory and ordering
NDC against lot number
The NDC identifies what the product is. The lot number identifies which manufacturing run it came from.
A recall usually names both: the product by NDC and the affected batches by lot. Confusing the two is a standard distractor.
Where it connects to serialization
The Drug Supply Chain Security Act builds product tracing on top of product and package identification. The NDC is part of what makes a unit identifiable through the supply chain. Three segments, three jobs.
Since serialization is a named knowledge area on the current outline, the connection is worth holding rather than treating NDC as a standalone fact. Different things entirely.
Common questions
What are the three parts of an NDC?
Labeler, product and package, under 21 CFR 207.33.
What does the product segment identify?
The specific strength, dosage form and formulation.
What is the difference between an NDC and a lot number?
The NDC says what the product is; the lot number says which manufacturing run it came from.
Why does NDC checking prevent errors?
Products differing only in the product segment are the ones most easily confused on a shelf.
How does it relate to serialization?
The DSCSA builds product tracing on product and package identification, of which the NDC is part.