The National Drug Code (NDC) is a unique identifier for drugs, while the Food and Drug Administration (FDA) is the regulatory agency that oversees and approves drugs in the United States. The NDC is used by the FDA to identify and track drugs.
Understanding the NDC and FDA
To understand the difference, let's break down each entity:
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National Drug Code (NDC):
- Think of the NDC as a unique serial number for a drug product.
- It's a three-segment number that identifies the labeler (manufacturer, repackager, or distributor), product (specific strength, dosage form, and formulation), and package size.
- It is used for tracking, billing, and inventory management.
- The FDA publishes these numbers in the NDC Directory. This directory is updated daily.
-
Food and Drug Administration (FDA):
- The FDA is a government agency responsible for protecting public health by regulating human and veterinary drugs, biological products, medical devices, food, cosmetics, and radiation-emitting products.
- It sets standards, reviews drug applications, inspects manufacturing facilities, and monitors the safety of products on the market.
- The FDA ensures that drugs are safe and effective before they can be sold in the U.S.
Key Differences Summarized
| Feature | National Drug Code (NDC) | Food and Drug Administration (FDA) |
|---|---|---|
| What it is | A unique identifier for drug products | A regulatory agency |
| Purpose | To identify and track drugs | To protect public health by regulating drugs and other products |
| Function | Identification, billing, and inventory | Approval, regulation, and oversight |
| Published By | FDA (in the NDC Directory) | N/A |
In essence, the NDC is a tool used by the FDA, and the FDA is the overarching organization that sets regulations and oversees drug safety. The NDC helps the FDA perform its regulatory functions.
