In the US FDA NDC (National Drug Code) system, a label represents the official identity of a drug product as it is listed with the US FDA. It connects the product, the responsible company, and the regulatory details used for tracking and compliance.
What “Label” Means in US FDA NDC
A label is not only the printed packaging text. In the NDC system, it is the regulatory record that defines:
- The company responsible for the drug
- The specific drug product and formulation
- The package configuration under which it is marketed
This label record is what the US FDA uses to recognize and manage a drug in its NDC Directory.
Label and the NDC Structure
Every labeled drug product is identified through a 3-part NDC code:
- Labeler Code
- Identifies the company responsible for the drug
- Assigned by the US Food and Drug Administration
- Product Code
- Identifies strength, dosage form, and route of administration
- Package Code
- Identifies package size and type
Together, these three segments define one unique labeled drug product.
What Information Is Included in a Label Record
A US FDA NDC label typically includes:
- Drug name (proprietary and non-proprietary)
- Dosage form and strength
- Route of administration
- Packaging details
- Marketing category
- Labeler (responsible company) information
This data forms the official US FDA drug listing entry.
Does a Label Mean US FDA Approval?
No.
A US FDA NDC label does not indicate approval.
It confirms that the drug is registered and listed, not that it has undergone an approval review.
Why the Label Is Important
- Mandatory for legally marketed drugs
- Enables traceability, recalls, and compliance monitoring
- Used by pharmacies, distributors, and regulators
- Required for manufacturing, distribution, and commercialization
Who Is Responsible for the Label?
The labeler—the company named on the label—is legally responsible for:
- Accurate NDC listing
- Keeping label information updated
- Maintaining ongoing US FDA compliance
How XPRO America Supports You
XPRO America is a US FDA Consultancy providing support for:
- NDC labeler code registration
- Drug listing and label compliance
- NDC updates and lifecycle maintenance
- End-to-end US FDA regulatory assistance
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