FDA LISTING INC: EXPERIENCED ADVISORS FOR FULL-SERVICE FDA REGISTRATION & COMPLIANCE
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U.S. FDA Registration
& Labeling Compliance Assistance
FDA National Drug Code NDC Labeler Code
How Is a Labeler Code Related to an NDC?
In the United States, by the FDA law, drug manufacturers are required to register their products with the FDA before distributing them. Each registered drug is assigned a unique identifier called the National Drug Code (NDC).
This 10-digit code is used to identify and track drug products and is also used for insurance billing purposes. The first segment of the NDC is known as the NDC labeler code, which identifies the company responsible for manufacturing or distributing the drug. The FDA assigns this code to each company.
Three Segments of an NDC
The National Drug Code (NDC) is a unique 10-digit identifier used to track drugs in the United States. It’s structured in three segments. The FDA assigns the first segment, the Labeler Code, while the drug company assigns the Product and Package Codes before submitting the drug to the FDA for listing.
Labeler Code – Assigned by the FDA to identify the manufacturer or distributor.
Product Code – Identifies the specific drug product.
Package Code – Identifies the size and type of the package.
The labeler code must be obtained before a drug can be listed, and the manufacturer or distributor assigns the product and package codes.
Steps to Obtain an NDC Labeler Code
- Preparing Company Information: Including your company name, DUNS number, contact info, and product category.
- Submit SPL via ESG: Submission via Structured Product Labeling (SPL) file through the FDA’s Electronic Submissions Gateway (ESG).
- Wait for FDA Review: Once approved, the FDA assigns your NDC labeler code. You can then list your drug with the full NDC.
Navigating the FDA’s digital systems can be confusing, especially for first-time applicants. At FDA Listing Inc., we help clients obtain an NDC labeler code quickly and efficiently by:
- Acting as your U.S. Agent.
- Preparing a compliant SPL submission.
- Communicating with the FDA on your behalf.
You can contact us by phone or email if you require assistance with the NDC Labeler code.
Service Details & Fees
395 USD
3-4 Days
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Frequently Asked Questions (FAQ)
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
Frequently Asked Questions (FAQ)
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
Service Details & Fees
Labeler Code Request
395 USD
Time Required
3-4 Days
U.S. Agent
FDA Communications
20-Mins Consultation
_______ Related Services _______