The last two digits of an National Drug Code (NDC) number specifically indicate the packaging of the drug product. This segment is crucial for distinguishing between various container sizes or types for the same drug formulation.
Understanding the NDC Number Structure
An NDC is a unique 10-digit or 11-digit, three-segment number that serves as a universal product identifier for human drugs in the United States. It's assigned by the Food and Drug Administration (FDA) and provides a standard way to identify drug products. Each segment of the NDC conveys specific information about the drug, aiding in proper identification, dispensing, and inventory management.
Here's a breakdown of the typical NDC format:
| NDC Segment | Digits | Indication |
|---|---|---|
| Labeler Code | 4 or 5 | Identifies the manufacturer or the labeler. |
| Product Code | 3 or 4 | Identifies the specific ingredient, strength, dosage form, and route of administration. |
| Package Code | 1 or 2 | Identifies the packaging (e.g., bottle size, count, or type of container). |
It's important to note that the number of digits in each segment can vary, but the total remains 10 or 11 digits when hyphens are removed (e.g., 5-4-1, 5-3-2, 4-4-2).
The Significance of the Package Code
The final segment, the package code, provides vital details about how the drug is packaged. While the product code specifies the drug itself, the package code differentiates it based on the commercial presentation.
Practical Insights and Examples:
- Inventory Management: Pharmacies and healthcare facilities rely on the package code to track specific stock units. For instance, a bottle containing 100 tablets of a medication will have a different package code than a bottle containing 500 tablets of the exact same medication, even if produced by the same manufacturer.
- Dispensing Accuracy: This segment helps prevent dispensing errors by ensuring that the correct package size or type is given to the patient, aligning with the prescribed quantity.
- Billing and Reimbursement: For insurance claims and reimbursement, the NDC (including the package code) ensures that the specific drug product dispensed is accurately identified and billed.
- Regulatory Compliance: The FDA uses the NDC system, including the package code, for various regulatory purposes, such as tracking drug products in the supply chain and facilitating recalls.
For more general information on National Drug Codes, you can refer to resources from the U.S. Food and Drug Administration (FDA).
