National Drug Code (NDC)

The National Drug Code (NDC) is a unique 10- or 11-digit, 3-segment number that serves as the universal identifier for human drugs in the United States. Every finished drug product marketed in the U.S. must have an assigned and listed NDC with the U.S. Food and Drug Administration (FDA).

At Catain, we provide end-to-end support for NDC assignment, listing, and maintenance, ensuring your products remain compliant throughout their lifecycle.

Our NDC Services Include:
NDC Number Assignment: Assistance with generating and assigning FDA-compliant NDC numbers for finished dosage forms, OTC drugs, prescription drugs, biologics, and combination products.
Structured Product Labeling (SPL) Preparation: Preparation and submission of SPL files in the FDA-required XML format to ensure smooth NDC listing in the FDA’s electronic Drug Registration and Listing System (eDRLS).
Initial NDC Listing: Submission of new drug products to the FDA with accurate NDC coding, labeler codes, product codes, and package codes.
NDC Updates and Maintenance: Managing NDC changes such as discontinuations, package size revisions, labeler name changes, or product code updates.
Annual NDC Certification Support with FDA’s annual certification requirement to keep your NDC listings current and compliant.
Strategic Consulting: Guidance on NDC-related queries, including product relabeling, private labeling arrangements, and supply chain compliance.

Why Choose Catain?
Regulatory Expertise – Years of experience working with FDA drug registration and listing.
Accuracy & Compliance – Meticulous preparation of SPL submissions to avoid rejections or compliance gaps.
Customized Solutions – Tailored support for small, mid-size, and large pharmaceutical companies.
End-to-End Service – From initial NDC assignment to ongoing FDA updates.