In the US FDA NDC (National Drug Code) framework, a label defines the official regulatory identity of a drug product as it is listed with the US FDA. It links the drug, the responsible company, and the packaging details used for compliance, tracking, and commercialization.
Understanding “Label” in the US FDA NDC System
A label goes beyond printed packaging text. In the NDC system, it is the authoritative record that identifies:
- The company responsible for the drug (the labeler)
- The specific drug formulation
- The way the product is packaged and marketed
This record is what appears in the US FDA NDC Directory and is used across the supply chain.
How the Label Relates to the NDC Code
Each labeled drug product is defined by a three-segment NDC:
- Labeler Code – Identifies the company responsible for the product and is assigned by the US Food and Drug Administration
- Product Code – Identifies the drug’s formulation, strength, and dosage form
- Package Code – Identifies package size and configuration
Together, these segments uniquely identify one labeled drug product.
What Information a US FDA NDC Label Contains
A standard NDC label record includes:
- Proprietary and non-proprietary drug name
- Strength and dosage form
- Route of administration
- Packaging details
- Marketing category
- Labeler (company) information
This information forms the official US FDA drug listing entry.
Does an NDC Label Mean US FDA Approval?
No.
Having an NDC label does not mean US FDA approval.
It confirms that the drug is properly listed and identified, which is a separate requirement from any approval or authorization process.
Why the Label Is Critical
- Required for legally marketing drugs in the US
- Enables traceability, recalls, and compliance monitoring
- Used by distributors, pharmacies, and regulators
- Essential for accurate product identification
Label Responsibility
The labeler—the company named on the drug label—is legally responsible for:
- Correct NDC listing
- Keeping label information current
- Ongoing US FDA compliance
XPRO America Support – support@xproamerica.com
XPRO America is a US FDA Consultancy supporting companies with:
- NDC labeler code registration
- Drug listing and label compliance
- Updates and lifecycle maintenance
- Complete US FDA regulatory assistance
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