Labeler Code
Identifies the company or entity responsible for listing the drug. The applicable process for obtaining a labeler code depends on FDA procedures.
U.S. DRUG LISTING SUPPORT
US FDA NDC Code Understand National Drug Code requirements and prepare your drug listing information with XPRO America.
The National Drug Code (NDC) is an identifier used for drug products listed with the U.S. Food and Drug Administration. An NDC is generally structured around a labeler code, product code, and package code. The steps that apply depend on the product, labeler, and regulatory status. XPRO America can help you understand the process and organize relevant information.
Who May Need NDC Code or Drug Listing Assistance?
NDC and drug listing obligations can apply to businesses involved with human drug products marketed in the United States. Applicability and exemptions vary, so each product should be assessed under the relevant FDA requirements.
Drug manufacturers and labelers
Prescription drug product listing
Over-the-counter (OTC) drug products
Product and package information preparation
Labeler code and NDC structure questions
Reviewing drug listing details and updates
Key Parts of an NDC Code
Product Code
Distinguishes a particular drug formulation, strength, dosage form, or other product characteristics within the labeler's listings.
Package Code
Distinguishes package configurations for a listed drug product, such as a particular package size or type.
Advantages of Accurate NDC and Drug Listing Information
Clear product identification
Helps distinguish a listed drug product and its package configuration in applicable FDA and commercial systems.
More consistent product records
Organized product, labeler, formulation, and package details can reduce avoidable data inconsistencies.
Better preparation for applicable requirements
Reviewing the relevant process can help businesses identify information needed for drug listing and updates.
Support for ongoing record maintenance
Keeping product and package information organized can make future changes and reviews easier to manage.
How to Get NDC Assistance Through XPRO America
Request a quote
Submit your contact details through the form so the XPRO America team can discuss your requirements.
Share product and labeler details
Prepare the company or labeler information, product name, active ingredients, strength, dosage form, and package details as applicable.
Review the applicable pathway
Confirm whether a labeler code, drug listing, NDC assignment, update, or other FDA process is relevant to your product.
Prepare and check the information
XPRO America can help organize information and explain process steps. Any submission, listing, or code remains subject to applicable FDA rules and procedures.
How XPRO America Can Help
Process Guidance
Understand NDC and drug listing steps relevant to your product.
Product Information
Organize key drug, labeler, and package details for review.
Listing Support
Identify applicable next steps and information to confirm.
Important FDA Notice
An NDC number or inclusion in an FDA drug listing does not, by itself, mean that FDA has approved the drug or verified its compliance. NDC requirements are not identical for every product. Confirm the applicable requirements with FDA guidance or a qualified regulatory professional.
Frequently Asked Questions
Does an NDC code mean a drug is FDA approved?
No. An NDC or drug listing is not, by itself, evidence of FDA approval. Approval requirements depend on the type of drug and the applicable regulatory pathway.
Does every product need an NDC?
No. Requirements depend on the product category, regulatory status, and applicable exemptions. Confirm the requirements for the specific product.
Can XPRO America issue an NDC or FDA approval?
XPRO America can assist with process guidance and organizing information. FDA procedures govern labeler code assignment and drug listing, and an NDC does not constitute FDA approval.
