NDC Code & Product Code
Registration Services
A National Drug Code (NDC) is FDA’s three-segment identifier used in drug-listing records to identify the labeler, drug product, and commercial package. FDA currently assigns 10-digit NDCs. The labeler proposes the product and package segments under its FDA-assigned Labeler Code as part of the electronic drug-listing process. An NDC identifies a listed drug product; it does not mean FDA has approved, endorsed, certified, or verified that product.
FDA Registration Assistance handles NDC product and package code setup, SPL drug-listing preparation, FDA Direct submission support, and NDC Directory verification for prescription and OTC drug products subject to U.S. drug-listing requirements.
What Is an NDC Code & Why Every Drug Product Needs One
Under 21 CFR Part 207, drug establishments must register and drug products subject to listing requirements must be listed for U.S. commercial distribution. The NDC is the three-segment identifier used within that system to identify the labeler, product, and commercial package. FDA currently assigns 10-digit NDCs; the uniform 12-digit 6-4-2 FDA format begins March 7, 2033.
FDA Registration Assistance reviews the underlying Labeler Code, establishment, product, ingredient, package, and labeling records, then prepares the SPL drug listing and supports submission through FDA Direct. We also verify the published listing data after acceptance.
- Supports applicable FDA drug-listing obligations under 21 CFR Part 207
- Three segments: Labeler Code, Product Code, and Package Code
- SPL drug-listing preparation and FDA Direct submission support
- NDCs are widely used in pharmacy and reimbursement systems; billing formats are separate from FDA’s assigned format
- Product, package, labeling, and establishment changes must be evaluated for required listing updates
Our NDC Code & Product Code Services
Everything drug companies need to obtain, assign, and file NDC codes correctly — from product code assignment to FDA drug listing, handled by experienced FDA compliance specialists.
NDC Product Code Setup
We review the formulation, strength, dosage form, route of administration, and marketing category, then establish the product-code segment under your FDA Labeler Code.
Package Code Setup
We review each commercial package size and type and establish the package-code structure for the configurations included in your service scope.
SPL Drug Listing Preparation
We prepare the Structured Product Labeling drug-listing data required by FDA, including NDC, product, ingredient, establishment, package, and labeling information.
FDA Direct Submission & Update Support
We support submission through FDA Direct and address filing, validation, or update issues that fall within the agreed service scope.
Current NDC & Drug Listing Facts
A quick view of the current FDA format, upcoming 2033 transition, and the professional fee for this service.
How Our NDC Code Registration Works
A simple four-step process to assign your NDC codes and file your SPL drug listing with the FDA.
Submit Product & Company Records
Provide the Labeler Code, legal entity information, product formula, labeling, establishment details, and commercial package configurations.
Regulatory Data Review
We review the product structure, ingredient identifiers, marketing category, establishment records, and package information before building the listing.
SPL Prepared & Submitted
We prepare the SPL drug listing and support submission through FDA Direct using the correct labeler and establishment records.
Listing Verified
After acceptance, we verify the published NDC / listing data and identify any follow-up or future update obligations.
What Every NDC Holder Must Do
Drug listing is an ongoing compliance record. The labeler and registered establishments must keep the underlying information current, complete required updates or certifications, and avoid representing an NDC as FDA approval.
Use a Unique Product-Code Structure
The product-code segment must distinguish the listed drug product under the labeler’s Labeler Code. Changes in formulation, strength, dosage form, or other product characteristics must be reviewed to determine whether a new product code is needed.
Use the Correct Package-Code Structure
Commercial package configurations must be represented accurately. A new package size or type may require a new package code and an updated SPL listing.
Maintain a Complete SPL Drug Listing
The SPL must contain the required NDC, product, ingredient, establishment, marketing, package, and labeling information using the correct labeler records.
Keep Listing Information Current
FDA expects drug-listing information to be updated as soon as possible after changes and, where periodic reporting is permitted, no later than the applicable June or December reporting period.
Complete the Annual No-Change Certification When Required
If no drug-listing information changed during the year, the required no-change certification is generally completed during October 1 through December 31. This is different from updating changed listing information.
Keep Establishment Registration Current
Drug establishments subject to registration must maintain their annual FDA establishment registration, while the associated product listings must also remain current or properly certified.
Never Present an NDC as FDA Approval
An NDC or NDC Directory entry does not mean FDA approved, endorsed, certified, or verified the product. Marketing copy should never imply otherwise.
Distinguish FDA NDC Format From Billing Format
FDA currently assigns 10-digit NDCs. Many payer systems use an 11-digit 5-4-2 reimbursement conversion. FDA’s uniform 12-digit 6-4-2 format begins March 7, 2033.
NDC Code vs. Drug Labeler Code
These two FDA identifiers are routinely confused — but they identify completely different things. The Labeler Code identifies the company; the NDC identifies a specific product configuration.
| Attribute | NDC (National Drug Code) | Drug Labeler Code |
|---|---|---|
| Who Establishes It | The labeler proposes the Product Code and Package Code under its FDA-assigned Labeler Code as part of drug listing; FDA accepts and publishes the resulting NDC data. | FDA assigns the Labeler Code after an acceptable Labeler Code request. |
| What It Represents | A listed drug product and commercial package under the labeler’s code. | The labeler identified in the FDA drug-listing system. |
| Regulatory Context | Used in drug listing under FD&C Act §510 and 21 CFR Part 207. | Requested and maintained under 21 CFR Part 207 as the first NDC segment. |
| Governing Regulation | 21 CFR Part 207 (drug registration and listing) | 21 CFR 207.33 and related provisions |
| Primary Function | Identifies a listed drug product/package in FDA’s drug-listing records and is also used by many downstream pharmacy and reimbursement systems. | Identifies the labeler and supplies the first NDC segment. |
| Our Professional Fee | $199 USD per drug product | $349 USD per company |
The filings are sequential, not interchangeable. A company needs the correct FDA Labeler Code before the NDC product/package segments can be established and the drug listing completed. FDA currently assigns 10-digit NDCs and moves to the uniform 12-digit 6-4-2 format on March 7, 2033.
Self-Filing vs. FDA Registration Assistance
FDA Direct is available to industry users at no charge, but a compliant drug listing still requires accurate product, ingredient, establishment, package, labeling, and marketing-category data. Our professional fee covers the regulatory work and submission support around that filing.
| Factor | Self-Filing (DIY) | Recommended FDA Registration Assistance |
|---|---|---|
| Cost | $0 FDA government fee for the standard NDC / drug-listing submission itself, plus your internal staff time and any tools you use. | $199 USD professional service fee per drug product for NDC setup, SPL preparation, FDA Direct submission support, and verification within scope. |
| Submission Monitoring | You monitor acknowledgments, validation messages, and any needed corrections yourself. | We monitor the filing status and address submission issues within the agreed scope. |
| Drug-Listing Data | You are responsible for product/package structure, ingredient identifiers, marketing-category data, establishment information, and labeling. | We review and prepare the listing data from the records you provide before submission. |
| Validation Risk | Incomplete or inconsistent data can delay acceptance or require correction. | We perform a pre-submission review intended to identify common data and consistency issues before filing. |
| Verification | You verify the published NDC / drug-listing data yourself. | We verify the NDC / listing data after acceptance and flag any follow-up needed. |
| Updates | You track required product changes, periodic updates, and annual no-change certification when applicable. | We can assist with later SPL amendments, listing updates, and certification support as a separate or continuing scope. |
FDA does not charge a separate government fee simply to assign an NDC or submit a standard drug listing. The $199 amount shown on this page is FDA Registration Assistance’s professional service fee, not an FDA fee.
NDC & Drug Listing Terms You Will Encounter
A quick reference of the technical acronyms, codes, and submission systems used throughout the NDC assignment and SPL drug listing process.
FDA’s three-segment identifier used in drug-listing records. FDA currently assigns 10-digit NDCs; the uniform 12-digit 6-4-2 format takes effect March 7, 2033.
The FDA-assigned first segment of the NDC. It identifies the labeler in FDA’s drug registration and listing system.
The second NDC segment, proposed by the labeler under its Labeler Code to distinguish a specific drug product.
The third NDC segment, proposed by the labeler to distinguish a commercial package configuration for the listed product.
The XML-based electronic format FDA uses for drug registration and listing submissions, including product, ingredient, establishment, package, and labeling data.
FDA’s free web-based SPL authoring and submission environment for drug establishment registration, drug listing, Labeler Code requests, NDC reservations, and related drug functions.
FDA’s electronic submission gateway used to transmit many compliant SPL submissions created outside FDA Direct or FDA’s SPL Xforms tools.
FDA’s public directory populated from drug-listing SPL data and updated daily. Directory inclusion reflects submitted listing information; it is not FDA approval.
FDA currently assigns 10-digit NDCs. Many reimbursement systems use an 11-digit 5-4-2 conversion. FDA’s uniform 12-digit 6-4-2 NDC format begins March 7, 2033.
The regulatory pathway declared in every SPL — NDA, ANDA, BLA, OTC monograph, unapproved drug, or compounded. The marketing category controls how the NDC is treated in FDA databases and pharmacy systems.
Unique Ingredient Identifier — a non-proprietary FDA code assigned to every drug substance and inactive ingredient. UNIIs are required in every SPL drug listing for both actives and excipients.
A business identifier used in FDA registration and listing workflows to help identify and align company and establishment records. The underlying legal name and address should remain consistent across regulatory records.
Why NDC Submissions Get Rejected or Pulled From the FDA Directory
These are common data, filing, and maintenance issues that can delay acceptance, require correction, or cause a listing to become inactive. We review them before submission and during follow-up.
Labeler Code or Entity Mismatch
If the Labeler Code, legal entity, or related company records do not align with the filing, the drug listing may require correction before it can be completed accurately.
Wrong or Incomplete Marketing Category
Drug listings must identify the appropriate marketing category and related application or monograph information when applicable. Incorrect or incomplete data can delay or prevent acceptance.
Missing or Incorrect Ingredient Identifiers
SPL drug listings require structured ingredient information. Missing or incorrect identifiers, strengths, or ingredient data can trigger validation or data-quality problems.
Incorrect Product or Package Structure
Product and package segments must accurately distinguish the listed product and commercial configurations. Reusing or structuring segments incorrectly can require correction and a revised SPL.
Missed Annual No-Change Certification
If no drug-listing information changed during the year, the required no-change certification is generally completed during October 1 through December 31. Listings that require certification but are not certified can become inactive in FDA publications.
Labeling and Listing Data Do Not Match
The product labeling and SPL listing should remain consistent. Differences in product name, strength, dosage form, package information, or other listed data can create regulatory and downstream data problems.
11-Digit Billing Conversion Errors
FDA currently assigns 10-digit NDCs, while many reimbursement systems use an 11-digit 5-4-2 conversion. A billing-format error can create payer problems even when the FDA-assigned NDC itself is correct.
Lapsed Establishment Registration or Outdated Listing
Drug establishments subject to registration must renew annually, and drug listings must be updated or certified as required. Inactive underlying records can affect the status and usefulness of the associated listing data.
Services Closely Connected to an NDC Drug Listing
These are the core filings most commonly needed before or alongside NDC / drug listing work. We keep this section limited to directly related drug-registration services.
Drug Establishment Registration
Register and maintain the drug manufacturing, repacking, or relabeling establishment record — $449/year professional service fee.
Labeler Code Registration
Obtain the FDA Labeler Code needed before NDC product/package segments can be established — $349 professional service fee.
DUNS Request Assistance
Obtain or resolve the DUNS information used to align FDA drug registration and listing records — $399 professional service fee.
Drug / OTC U.S. Agent Services
U.S. Agent representation for foreign drug establishments that must designate a U.S. contact with FDA — $449/year professional service fee.
Frequently Asked Questions — NDC Code & Product Code Registration
Direct answers about NDC format, Labeler Codes, SPL drug listings, professional fees, update timing, foreign companies, and NDC Directory verification.
What is an NDC code?
A National Drug Code (NDC) is FDA’s three-segment identifier used in drug-listing records to identify the labeler, drug product, and commercial package. FDA currently assigns 10-digit NDCs. The product and package segments are proposed under the FDA-assigned Labeler Code as part of the drug-listing process.
Does having an NDC mean my drug is FDA-approved?
No. An NDC identifies a listed drug product; it does not mean FDA has approved, endorsed, certified, or verified the product. FDA specifically warns that NDC assignment or inclusion in the NDC Directory should not be represented as FDA approval.
What is the current NDC format, and when does the 12-digit format begin?
FDA currently assigns 10-digit NDCs. Many pharmacy and reimbursement systems convert them to an 11-digit 5-4-2 format for billing. FDA’s uniform 12-digit 6-4-2 NDC format takes effect March 7, 2033. FDA will continue assigning 10-digit NDCs through March 6, 2033.
Do I need an FDA Labeler Code before an NDC can be listed?
Yes. The Labeler Code is the first NDC segment and must be in place before the product and package segments can be established and the drug listing completed. If you do not yet have a Labeler Code, FDA Registration Assistance can handle that filing first.
What information is needed for NDC / drug listing?
Typical information includes the legal labeler name, Labeler Code, product name, dosage form, route of administration, active and inactive ingredients, strengths, marketing category, manufacturing-establishment information, package configurations, and current product labeling.
How much does NDC Code / Product Code service cost?
Our professional service fee is $199 USD per drug product for NDC setup, SPL drug-listing preparation, FDA Direct submission support, and listing verification within the agreed scope. FDA does not charge a separate government fee simply to assign an NDC or submit a standard drug listing.
How is the drug listing submitted to FDA?
Drug registration and listing data are submitted electronically in Structured Product Labeling (SPL) format. FDA Direct, formerly CDER Direct for drug functions, is FDA’s free web-based SPL authoring and submission environment. Other compliant SPL tools may use FDA ESG NextGen for transmission.
When must an FDA drug listing be updated or certified?
FDA requires drug-listing information to be kept current. Changes should be submitted as soon as possible and, where periodic reporting is permitted, no later than the following June or December reporting period. If no listing information changed during the year, the required no-change certification is generally completed during October 1 through December 31.
Can a foreign drug company obtain NDCs?
Yes. Foreign firms can list drug products for U.S. commercial distribution. The correct setup depends on the company’s role; foreign drug establishments generally must maintain FDA establishment registration and designate a U.S. Agent in addition to meeting applicable drug-listing requirements.
What is the difference between an NDC and a Drug Labeler Code?
The Labeler Code identifies the labeler and forms the first segment of the NDC. The complete NDC combines that Labeler Code with a product code and package code so a specific listed drug and commercial package can be identified.
Can one drug product have more than one NDC?
Yes. Different commercial package configurations can require different package codes, producing different complete NDCs even when the underlying formulation and strength are the same. We review every package size and type before building the listing.
How do I verify an NDC in FDA’s database?
FDA’s National Drug Code Directory is updated daily from submitted drug-listing data. You can search by NDC, product name, or labeler. Directory inclusion reflects submitted listing information and should not be interpreted as FDA approval or a guarantee of reimbursement.
Start Your NDC Code / Drug Listing
Send us your product and company details. We’ll review what is already in place, identify any prerequisite filing, and determine the correct NDC / SPL drug-listing path.
Prefer to speak with us? Call 928-275-8333 or email info@fdaregistrationassistance.com.
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