In the US FDA NDC (National Drug Code) system, a label refers to the official identification and presentation of a drug product as it is registered and listed with the US Food and Drug Administration.
It is not just the physical sticker on a package—it is a regulatory identity that links the product, manufacturer, and drug details inside the FDA’s NDC database.
Meaning of “Label” in US FDA NDC
In US FDA terminology, a label represents the drug product as marketed by a specific company, including:
- Who manufactures or distributes the drug
- What the drug is
- How it is packaged and presented
Each label is uniquely connected to an NDC number, which allows the US FDA to track the drug in the market.
How the Label Fits Into the NDC Structure
The US FDA NDC is a 10-digit, 3-segment code, and the labeler segment is the most important part.
1. Labeler Code
- Identifies the company responsible for the drug
- Assigned directly by the US FDA
- Represents the label owner (manufacturer, packer, or distributor)
2. Product Code
- Identifies the specific drug formulation
- Includes strength, dosage form, and route of administration
3. Package Code
- Identifies package size and type
Together, these three parts define one unique labeled drug product.
What Information Is Tied to a Label?
When a drug is listed under a label in the US FDA NDC system, it includes:
- Drug proprietary and non-proprietary name
- Dosage form and strength
- Route of administration
- Package configuration
- Marketing category
- Labeler (company) details
This information becomes part of the official US FDA drug listing record.
Is the Label the Same as FDA Approval?
No.
A label in the NDC system does not mean FDA approval.
- NDC listing = product identification and registration
- FDA approval = separate regulatory review process (when applicable)
The label simply ensures the drug is properly identified and traceable in the US FDA system.
Why the Label Is Important in US FDA NDC
- Mandatory for legally marketed drugs in the US
- Enables product tracking, recalls, and compliance checks
- Required for drug manufacturing, distribution, and commercialization
- Used by pharmacies, wholesalers, and regulators
Who Is Responsible for the Label?
The labeler—the company whose name appears on the drug label—is legally responsible for:
- Accurate NDC listing
- Timely updates to drug information
- Regulatory compliance with US FDA rules
This is why professional US FDA consultancy support is often required.
How XPRO America Helps
XPRO America is a US FDA Consultancy that assists companies with:
- US FDA NDC labeler code registration
- Drug listing and label compliance
- Ongoing NDC updates and maintenance
- End-to-end US FDA regulatory support
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