What is the NDC?
NDC National Drug Code
NDC is a unique, standardized 10- or 11-digit number that identifies drugs in the United States, assigned by the Food and Drug Administration (FDA). The NDC serves as a universal product identifier for medications and is used for tracking, inventory management, billing, and regulatory compliance.
Structure of the NDC:
Example:
• NDC 12345-6789-01
o 12345 = Labeler (manufacturer)
o 6789 = Product (e.g., 10 mg tablets)
o 01 = Package (e.g., bottle of 100 tablets)
The NDC is typically presented in one of three segmented formats: NDC9, NDC11 and NDC10. NDC10 most often used and written as 10 or 11 digits divided into three segments:
1. Labeler Code (assigned by the FDA)
• Identifies the company that manufactures or distributes the drug.
• Typically 4 or 5 digits.
2. Product Code
• Identifies the specific strength, dosage form, and formulation of the drug.
• Typically 3 or 4 digits.
3. Package Code
• Identifies package size and type.
• Typically 1 or 2 digits.
• Bulk package vs. individual package will have different numbers here and DO NOT match with the actual number in a bulk package.
• For example: A single item may say -42 and a bulk package might be -01.
Note: For billing and databases, the NDC is often converted to a standardized 11-digit format by padding with leading zeroes as needed (e.g., 012345678901).
Uses of NDC:
• Pharmacy and hospital inventory systems
• Medical billing and insurance claims
• Drug recalls and safety alerts
• FDA tracking and regulation
Structure of the NDC:
Example:
• NDC 12345-6789-01
o 12345 = Labeler (manufacturer)
o 6789 = Product (e.g., 10 mg tablets)
o 01 = Package (e.g., bottle of 100 tablets)
The NDC is typically presented in one of three segmented formats: NDC9, NDC11 and NDC10. NDC10 most often used and written as 10 or 11 digits divided into three segments:
1. Labeler Code (assigned by the FDA)
• Identifies the company that manufactures or distributes the drug.
• Typically 4 or 5 digits.
2. Product Code
• Identifies the specific strength, dosage form, and formulation of the drug.
• Typically 3 or 4 digits.
3. Package Code
• Identifies package size and type.
• Typically 1 or 2 digits.
• Bulk package vs. individual package will have different numbers here and DO NOT match with the actual number in a bulk package.
• For example: A single item may say -42 and a bulk package might be -01.
Note: For billing and databases, the NDC is often converted to a standardized 11-digit format by padding with leading zeroes as needed (e.g., 012345678901).
Uses of NDC:
• Pharmacy and hospital inventory systems
• Medical billing and insurance claims
• Drug recalls and safety alerts
• FDA tracking and regulation