Drug registration and NDC number might sound technical, but they play a big role in how medications make it to the U.S. market. If you’re in the pharmaceutical space, understanding how these systems work is key to getting your products approved, listed, and safely into the hands of patients.
In this guide, we break it all down in a simple, accessible way. You’ll learn what’s involved in registering a drug, how the National Drug Code (NDC) number works, and why both matter for compliance, billing, and patient safety.
So, if you’re looking for clarity, keep reading, and we’ll help you move forward with confidence.
What is drug registration?
Before a medication can be sold in the U.S., it must go through a thorough registration process. This step is essential because it ensures the drug is safe, effective, and meets the U.S. Food and Drug Administration (FDA) standards. To give you a clearer picture, here’s a simplified overview of the main steps involved:
1. Preclinical Testing
At the start, the drug is tested in labs and on animals to evaluate safety and potential effectiveness. This foundational research helps determine if it’s ready for further testing.
2. IND Application
Next, if the preclinical data is promising, the manufacturer submits an Investigational New Drug (IND) application to the FDA. This includes details about the drug’s composition, how it’s made, and how it will be tested in people.
3. Clinical Trials
Then come the clinical trials, which take place in three main phases:
- Phase I: Small group to test safety and dosage.
- Phase II: Larger group to test how well it works and any side effects.
- Phase III: Even bigger group to confirm effectiveness and monitor long-term side effects.
4. NDA or BLA Submission
After successful clinical trials, the next step is submitting a New Drug Application (NDA) or Biologics License Application (BLA). This submission includes all the collected data from previous steps.
5. FDA Review and Approval
From there, the FDA conducts a comprehensive review. If the drug meets all requirements, it’s approved for sale in the U.S., often with specific labeling and safety conditions.
6. Post-Market Monitoring
Finally, even after approval, the drug isn’t left unchecked. It’s continuously monitored for safety. New side effects may emerge, and labeling may be updated accordingly.
Why the NDC number matters
The National Drug Code (NDC) works like a barcode for medications in the U.S., making it easier to identify, track, and manage drug products throughout their life cycle. As a result, it plays a central role in helping manufacturers, healthcare providers, and regulatory bodies maintain accuracy and transparency.
Specifically, the NDC is made up of three parts: 1. the labeler code, assigned by the FDA to identify the manufacturer or distributor; 2. the product code, which defines the specific drug, its strength, and dosage form; and 3. the package code, which reflects the packaging type and size. For example, a full NDC might look like this: 12345-6789-01.
Together, these segments ensure that the right drug is listed, billed, dispensed, and monitored correctly across the healthcare system. In turn, this structure helps reduce errors, streamline inventory, and improve patient safety.
Breaking down the NDC segments
The National Drug Code is made up of three main segments: the labeler code, product code, and package code. Together, they provide a full picture of a drug product’s origin, formulation, and packaging. To make it easier to understand, here’s a quick summary of each component in table format for easier reference:
Segment | Assigned by | What it identifies |
Labeler code | FDA | Identifies the manufacturer or distributor. Also used in FDA listings and billing. |
Product code | Manufacturer | Indicates the drug’s strength and dosage form. Appears on labels and listings. |
Package code | Manufacturer | Details packaging configuration and size for inventory, labeling, and accuracy. |
As a result, this structured format not only helps with accurate product identification but also improves compliance and traceability throughout the entire pharmaceutical supply chain.
Key tips for drug manufacturers
If you’re a manufacturer, here’s what else you should know:
- Know your NDC format: Most NDCs are 10 digits, but the FDA also accepts 11-digit formats for billing. Some over-the-counter (OTC) drugs use a 5-3-2 format.
- Use unique NDCs: Different strengths or forms (like a tablet vs. syrup) need separate NDCs, even if it’s the same drug.
- Private labeling: If you sell to private labels, those versions also need their own NDCs.
- Repackaging needs a new NDC: If you change the packaging, assign a new NDC to reflect that.
- Keep your info updated: Always notify the FDA if your codes change or a product is discontinued.
- Stay compliant with other countries: The NDC is U.S.-specific. If you’re exporting, be aware of global regulations too.
Final thoughts
Drug registration and the NDC number are more than just paperwork. In fact, they are essential tools for maintaining safety, transparency, and regulatory compliance in the pharmaceutical industry. By staying informed and keeping documentation current, you set your products up for long-term success.
At Quality Smart Solutions, we specialize in helping companies register their drug products with Health Canada. From DIN applications to Drug Establishment License (DEL) support, our team of experts is here to guide you every step of the way.
Ready to get started? Contact us or fill out the form below for a free consultation. We’re here to make the process smoother and help you meet your regulatory goals with confidence. Explore our FDA OTC drug compliance solutions to learn more about how we can support your U.S. drug compliance strategy.
Visit the FDA’s official NDC Directory to look up or verify drug listings. Learn about Canadian drug registration on the Health Canada website.
