Quick Answer
The National Drug Code (NDC) is a unique 10-digit or 11-digit identifier assigned to drugs marketed in the United States. The NDC identifies the labeler, product, and package size. Drug manufacturers, repackers, and private label distributors must obtain a labeler code from FDA and list their products with NDC numbers in FDA's NDC Directory.
Regulatory Authority: 21 CFR Part 207, Subpart C — Procedures for Domestic Drug Establishments
What Is an NDC Number?
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ImmutableThe National Drug Code (NDC) is a unique product identifier used in the United States for drugs intended for human use. Established under the Drug Listing Act of 1972, the NDC provides a universal product identifier for drugs that serves as a key identifier in pharmacy systems, billing, and regulatory compliance.
The NDC appears on all drug labels and is used throughout the healthcare industry for inventory management, prescription processing, insurance claims, and regulatory reporting.
Labeler Code
Identifies the manufacturer, repacker, or distributor (first segment)
Product Code
Identifies the specific drug, strength, and dosage form (second segment)
Package Code
Identifies the package size and type (third segment)
What Is the NDC Number Format?
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The NDC is divided into three segments. While the total is 10 digits, the way these digits are distributed across segments can vary:
Common NDC Formats
| Format | Labeler | Product | Package | Example |
|---|---|---|---|---|
| 4-4-2 | 4 digits | 4 digits | 2 digits | 0002-1433-80 |
| 5-3-2 | 5 digits | 3 digits | 2 digits | 12345-123-01 |
| 5-4-1 | 5 digits | 4 digits | 1 digit | 12345-1234-1 |
| 5-4-2 (11-digit) | 5 digits | 4 digits | 2 digits | 12345-1234-01 |
11-Digit NDC
While the NDC is technically 10 digits, many systems use an 11-digit format by adding leading zeros to one of the segments. This standardization makes electronic processing easier. The conversion follows these rules:
- 4-4-2 becomes 04444-4444-22 (add leading zero to labeler)
- 5-3-2 becomes 55555-0333-22 (add leading zero to product)
- 5-4-1 becomes 55555-4444-01 (add leading zero to package)
Format Matters
When searching the NDC Directory or entering NDCs in systems, the format matters. A search for "12345-1234-1" may not find "12345-1234-01" depending on the system. Know which format your systems expect.
Who Needs an NDC Number?
An NDC is required for all drugs intended for human use distributed in the United States. This includes:
- Prescription drugs: All prescription medications
- OTC drugs: Over-the-counter medications
- Homeopathic drugs: Drugs marketed under homeopathic guidelines
- Insulin: All insulin products
- Compounded drugs: In many cases
Who Must Obtain a Labeler Code?
- Drug manufacturers
- Drug repackers and relabelers
- Private label distributors
- Some compounding pharmacies
How Do I Get an FDA Labeler Code?
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"Procedures for verifying supplier controls were not adequately established."
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Before you can assign NDC numbers to your products, you must obtain a labeler code from FDA. The labeler code uniquely identifies your firm.
Step 1: Obtain a DUNS Number
You need a Data Universal Numbering System (DUNS) number from Dun & Bradstreet before applying for a labeler code. If your company doesn't have one, request it through D&B.
Step 2: Register Your Establishment
Drug establishments must be registered with FDA. This is separate from (but related to) obtaining a labeler code. See our Drug Establishment Registration Guide for details.
Step 3: Request Labeler Code
Submit your labeler code request through FDA's Drug Registration and Listing System (DRLS). You'll provide:
- Company name and address
- DUNS number
- Contact information
- Type of business activity
FDA assigns labeler codes at no charge. Once assigned, your labeler code is permanent and uniquely yours.
How Do I Assign NDC Numbers to My Products?
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Once you have your labeler code, you assign the product and package codes yourself. These codes are not assigned by FDA -- it's your responsibility to create a logical system.
Product Code Assignment
Create unique product codes for each distinct drug product. Different codes are needed for:
- Different active ingredients
- Different strengths of the same drug
- Different dosage forms (tablet vs. capsule)
- Different formulations
Package Code Assignment
Create unique package codes for each package size and type:
- Different quantities (30-count vs. 90-count)
- Different package types (bottle vs. blister pack)
- Different configurations
Best Practices for NDC Assignment
- Create a logical system: Develop a numbering convention that makes sense for your product line
- Document assignments: Maintain a master list of all NDC assignments
- Reserve numbers: Leave gaps for future products
- Never reuse: Never reuse an NDC for a different product
How Do I List Drugs in the NDC Directory?
After assigning NDC numbers, you must list your drug products in FDA's NDC Directory. Drug listing is a legal requirement, not optional.
Required Listing Information
- NDC number
- Proprietary (brand) name
- Nonproprietary (generic) name
- Dosage form
- Route of administration
- Active ingredients and strengths
- Package descriptions
- Marketing status (prescription, OTC)
- Application number (NDA, ANDA, BLA) if applicable
Listing Timeline
- Initial listing: Within 5 days of beginning commercial distribution
- Updates: Within 30 days of changes to listing information
- Discontinuation: Update listing when product is discontinued
How Do I Maintain My NDC Listings?
NDC listings require ongoing maintenance to remain current and compliant.
Annual Registration Renewal
Drug establishments must renew registration annually (October 1 - December 31) and confirm drug listings
Listing Updates
Update listings within 30 days when product information changes
When to Update Listings
- New package size introduction
- Labeling changes
- Product discontinuation
- Marketing status change
- Formulation changes
- Company name or address changes
What Are the Most Common NDC Problems?
Duplicate NDCs
Accidentally assigning the same NDC to different products
Solution: Maintain a master NDC log; verify uniqueness before assignment
Unlisted NDCs
Products in distribution without FDA listing
Solution: List all products within 5 days of commercial distribution
Outdated Listings
NDC Directory information doesn't match current product
Solution: Update listings within 30 days of any changes
Incorrect Format
NDC format on label doesn't match listing
Solution: Ensure label NDC format matches registered format exactly
Reused NDCs
Assigning discontinued product's NDC to new product
Solution: Never reuse NDCs; assign new codes for new products
What Barcode Requirements Apply to NDC Numbers?
Drug products must display the NDC in a barcode format that can be scanned for verification and tracking.
Barcode Standards
- Linear barcodes: Traditional 1D barcodes encoding the NDC
- 2D barcodes: DataMatrix codes containing NDC plus additional information (lot, expiration)
DSCSA Requirements
The Drug Supply Chain Security Act (DSCSA) requires 2D barcodes on prescription drug packages containing:
- NDC
- Serial number
- Lot number
- Expiration date
What Steps Are Needed for NDC Registration?
NDC Registration Checklist
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