FDA: Drugs US Brokerage, 01/2016
FDA Product Data Sheet: Drugs
Account Number
Account Name
DUNS Number (if available)
Client Part Number*
Description of Product (as complete as possible)
Government Agency Processing Code
Select One
Tariff Number
FDA Product Code (if known)
Customs Country of
Origin**
FDA Country of
Production**
Type of Product
Select One
Product is for
Cargo Storage Status
Intended use
Ingredient(s)
Percentage of Active
Ingredient
Brand Name
* 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
Address
City
State/Province
Zip/Postal Code
Country
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)
Other:
FDA Shipper (As shown on Customs document, BOL or airway bill)
Address
City
State/Province
Zip/Postal Code
Country
DUNS Number (if available)
Select one
Select one
Select one
Select one