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National Drug Code (NDC) Services
FDA-Compliant NDC Registration—Simplified for U.S. Pharma.
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What Is National Drug Code (NDC) Services?
An NDC (National Drug Code) is a 10-digit or 11-digit , three-segment identifier assigned by the FDA to uniquely identify human drug products in the United States. It captures:
Labeler Code – the first set of numbers identifies the company or drug manufacturer
Product Code – the second set specifies drug strength, dosage, and form
Package Code – the third set defines package type and size
Every drug listed in the U.S. must have an NDC and be included in the FDA's NDC Directory, which is updated daily using Structured Product Labeling (SPL) submissions. This applies to:
Prescription and over-the-counter (OTC) drugs
Finished and unfinished formulations
Repackaged and relabeled products
Both approved and unapproved drugs marketed under FDA guidance
Why Is National Drug Code (NDC) Services Important?
Market Legitimacy
An FDA-listed NDC confirms your product’s eligibility to be sold in the U.S.
Regulatory Compliance
Accurate drug listing is a federal requirement under the FDCA
Supply Chain Integrity
Distributors and pharmacies rely on NDCs for tracking and ordering
Distributors and pharmacies rely on NDCs for tracking and ordering
Payers and PBMs use NDCs to validate coverage and pricing
Recall Management
NDCs support traceability and product safety communications
Process Flow for National Drug Code (NDC) Services
Initial Assessment
We evaluate your product profile, determine listing obligations, and map your regulatory path.
Labeler Code Assistance
We assist in submitting a Labeler Code Request to the FDA for new applicants.
Data Collection & Review
You provide product data, including formulation, dosage, packaging, and we conduct a technical check.
SPL File Creation
We generate an FDA-compliant SPL file using the proper coding, XML structure, and validations.
FDA Submission & Confirmation
We file the SPL through the FDA ESG portal and confirm your product’s listing in the NDC Directory.
Post-Submission Support
We track FDA updates, renew listings, and update your NDC when changes to the product occur.
How Can We Help in National Drug Code (NDC) Services?
Specialized Experience: Decades of FDA regulatory expertise focused on NDC and SPL compliance
End-to-End Service: From new drug launch to change reporting, we handle the full lifecycle
Speed with Accuracy: Our streamlined workflows ensure fast turnarounds without cutting corners
Dedicated Consultants: You'll work directly with regulatory professionals who know your product
Services
| Service | Details |
|---|---|
| NDC Code Request & Labeler Code Acquisition |
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| SPL File Preparation & Submission |
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| Product Data Review & Compliance Checks |
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| Ongoing FDA Listing Maintenance |
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| Regulatory Advisory for Edge Cases |
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Regulatory Requirements for National Drug Code (NDC) Services
Documents
To prepare and submit an NDC listing, the following product and regulatory data is required
- Labeler Code Confirmation (from FDA)
- Product Label or Draft Label (PDF or image)
- Drug Product Details (Manufacturer or labeler information, drug name, dosage form, strength, route of administration)
- Packaging Details
- Establishment Registration Info – Facility DUNS numbers and contact roles for manufacturer, packager, relabeller
- Drug listing submission via the Electronic Drug Registration and Listing System (eDRLS)
- Marketing Category – NDA, ANDA, OTC monograph, or unapproved
- Structured Product Labeling (SPL) XML File (created by consultant or internally)
Timeline
Labeler Code Assignment
5–10 business days after submitting the Labeler Code Request to FDA.
NDC Listing via SPL Submission
Once the labeler code is active, an SPL drug listing can typically be *submitted and accepted within 1–3 business days*, assuming data is complete and valid.
Total Duration (Start to Finish)
Typically *7–15 business days* depending on readiness of documents and FDA response times.
Regulatory Body
The U.S. Food and Drug Administration (FDA), specifically under the *Center for Drug Evaluation and Research (CDER), oversees the NDC registration process.
Fees
The FDA does not charge a fee for obtaining an NDC number or drug listing, but other regulatory filings related to drug approval may have associated costs. However, user fees under programs such as CDER (e.g., OTC Monograph Drug User Fees or GDUFA fees) may apply depending on product type and facility* involvement.
Validity
NDC Listing Validity
The NDC remains active as long as the product is marketed and the drug listing is kept current unless the product is discontinued or reformulated.
Annual Certification
The FDA requires drug listings to be certified annually between October 1 and December 31, even if no changes have occurred.
Updates Required for Changes
Any change in formulation, labeling, packaging, or marketing status must trigger a new SPL submission and updated listing.
Frequently Asked Questions(FAQs)
Do I need an NDC even for an OTC product?
Yes. All drug products marketed in the U.S., including OTC and homeopathic, must be listed in the FDA’s NDC Directory.
How long does it take to get an NDC?
If all documents are ready, we can help complete NDC listing in as little as 2–5 business days.
What if my product formulation changes?
You are required to update your FDA listing promptly. We assist with all post-market updates.
Can unapproved drugs be listed?
Some unapproved drugs (e.g., homeopathic or pre-1938 grandfathered drugs) can be listed. We evaluate eligibility on a case-by-case basis.
What happens if I don’t list my NDC?
Failure to list can result in FDA enforcement actions and market restrictions.
