FDA: Drugs US Brokerage, 01/2016
FDA Product Data Sheet: Drugs
DUNS Number (if available)
Description of Product (as complete as possible)
Government Agency Processing Code
Select One
FDA Product Code (if known)
Customs Country of
Origin**
FDA Country of
Production**
Type of Product
Select One
Percentage of Active
Ingredient
* Part number as shown on Customs document to identify the product (item number, SKU, etc.)
** U.S. Customs considers the country of origin to be the country where the product last underwent a “substantial transformation” (resulting in an
increase in value.) The FDA considers the country of origin to be that of the actual manufacturer. Actual manufacturer is defined as the last party
involved in the production of the food. 21 CFR 1.227(b)(2)
FDA Actual Manufacturer
DUNS Number (if available)
Drug Listing Number (Provide for all applicable)
DA: New Drug Application Number (formerly NDA, ANDA & BLA)
REG: Drug Registration Number (DUNS Number)
IND: Investigative New Drug Number
DLS: Drug Listing Number (formerly NDC Number)
FDA Shipper (As shown on Customs document, BOL or airway bill)
DUNS Number (if available)