The US FDA Drug Listing process is a mandatory compliance requirement for all human and veterinary drug products marketed in the United States. Under 21 CFR Part 207, every registered drug establishment must submit detailed information about each drug product they manufacture, repack, relabel, or distribute. This process ensures the FDA maintains an accurate and up-to-date database of all drugs available in the U.S. market.

A critical part of this process is obtaining and maintaining a valid National Drug Code (NDC) number. The NDC is a unique, 10-digit, 3-segment identifier assigned to each drug product, which provides essential information including the labeler code, product code, and package code. The NDC is widely used by healthcare providers, pharmacies, insurers, and regulators to identify and track drug products throughout the supply chain.

Drug Listing must be submitted electronically to the FDA in Structured Product Labeling (SPL) format. The SPL submission includes details such as:

• Proprietary and established drug name
• Dosage form, strength, and route of administration
• Active and inactive ingredients
• Packaging information
• Labeling images and prescribing information (if applicable)

Maintaining an accurate and updated drug listing is not optional. Failure to list or update drugs with the FDA can result in:

• Import refusals for foreign facilities
• Product recalls or market withdrawal
• Enforcement actions, including warning letters

At XPRO America, we specialize in assisting pharmaceutical companies with:

• NDC Number Assignment for all marketed drug products
• SPL Document Preparation and Submission through FDA’s ESG system
• Ongoing Updates to maintain compliance when formulations, labeling, or packaging changes occur
• Biennial Renewal Support to keep drug listings active and compliant

With XPRO America as your compliance partner, your company can confidently market pharmaceutical products in the United States, knowing that your Drug Listing and NDC assignments are handled with accuracy and in full compliance with FDA requirements.

XPRO America provides expert support for FDA Drug Listing, NDC number assignment, and SPL submissions to keep pharmaceutical products compliant in the U.S.