Step 1
Step 2

Company Name :

First Name :

Last Name :

Email :

Conform Email :

Labeler Name ( Private Label Distributor or Manufacturer ) :

DUNS Number :

If you do not have the DUNS number mention "123456789" , we will search D&B database and check if your company has already a DUNS number.

5 digit Labeler code assigned by the FDA. :

If labeler code is not available , please complete the below online form. Click on "Add Entry", after you complete the form you can return to the drug listing form.

Labeler Code Request Form

Add Entry

Manufacturer is registered with FDA ?
YES NO
If your manufacturer is not registered , we will redirect to manufacturer registration form.

Manufacturer Details

Manufacturer Name As per FDA registration database

Manufacturer DUNS Number

Operations performed

Upload all the product labels in PDF or JPEG format

If you have more than 20 mb product label you can send through email

Labeling information - Please upload Drug Facts or Prescription labeling information in the text format such MS- Word or PDF document.

Terms and Conditions

I Accept Terms and Conditions

Verification code

DUNS Number - DUNS number is mandatory, if you do not have the DUNS number, please mention 123456789 and we will check if your company has a DUNS number assigned by D&B.

State/Region/Province

DUNS number - This is mandatory, if you do not know the DUNS number mention 123456789 and we will search if your company already has a DUNS number

Address of the manufacturing facility

State/Region/Province

If you want to add different corporate address then please add then please complete the below section.

Registrant Information (Parent company name, head qurters)

State/Region/Province

	API MANUFACTURE
	DISTRIBUTES DRUG PRODUCTS UNDER OWN PRIVATE LABEL
	FDF MANUFACTURE
	HUMAN DRUG COMPOUNDING OUTSOURCING FACILITY
	IMPORT
	LABEL
	MANUFACTURE
	OUTSOURCING ANIMAL DRUG COMPOUNDING
	PACK
	RELABEL
	REPACK

	Compounding from bulk ingredient
	Contract manufacturing
	Contract manufacturing for human over-the-counter drug products produced under a monograph
	Distributes human prescription drug products
	Distributes human over-the-counter drug products
	Intent to compound 506E (drug shortage) drugs
	Manufactures animal prescription drug products
	Manufactures animal over-the-counter drug products
	Manufactures animal over-the-counter Type A medicated article drug products
	Manufactures human over-the-counter drug products not produced under an approved drug application or under a monograph
	Manufactures human over-the-counter drug products produced under a monograph
	Manufactures human over-the-counter drug products produced under an approved drug application
	Manufactures human prescription drug products
	Manufactures Non-Generics

	ANALYSIS
	API/FDF ANALYTICAL TESTING
	API MANUFACTURE
	DISTRIBUTES DRUG PRODUCTS UNDER OWN PRIVATE LABEL
	FDF MANUFACTURE
	HUMAN DRUG COMPOUNDING OUTSOURCING TESTING
	LABEL
	MANUFACTURE
	PACK
	RELABEL
	REPACK

	Compounding from bulk ingredient
	Contract manufacturing
	Contract manufacturing for human over-the-counter drug products produced under a monograph
	Distributes human prescription drug products
	Distributes human over-the-counter drug products
	Intent to compound 506E (drug shortage) drugs
	Manufactures animal prescription drug products
	Manufactures animal over-the-counter drug products
	Manufactures animal over-the-counter Type A medicated article drug products
	Manufactures human over-the-counter drug products not produced under an approved drug application or under a monograph
	Manufactures human over-the-counter drug products produced under a monograph
	Manufactures human over-the-counter drug products produced under an approved drug application
	Manufactures human prescription drug products
	Manufactures Non-Generics

NDC- Drug Listing Form