Drug Listing Form
Labeler (Must be same as in the NDC Labeler code)
*
Labeler Name
Labeler DUNS Number
*
Name of Contact Person
*
Phone No
Manufacturer
(Name of Establishment manufacturing the Drug)
*
Manufacturer Name
Manufacturer DUNS Number
Drug Product Information
*
Proprietary Name (Brand Name)
Proprietary Name Suffix
*
Intended Use of the Drug
Package type
(carton, tube, box, bottle etc..)
Inner Package
Labeler Code (10 Digits)
*
Outer Package
*
Labeler Code (10 Digits)
Attach Label Image
DEA Schedule
(if applicable)
CI
CII
CIII
CIV
CV
Characteristics
*
Route of Administration
Dosage Form
Flavor
Color
Shape
Size
Scoring
Imprint Informations
*
Marketing Start Date
Marketing Category (if OTC please enter Monograph No..)
*
Quantity (Nt.wt)
Active Ingredients
Active Ingredient
(eg. Avobenzone )
Strength
(eg.200mg in 1 ML)
UNII
(if known)
(Unique Ingredient Identifier)
Please list All
Active
Ingredients,
Strength and
UNII (if known)
1.
2.
3.
4.
(please use
additional form if
you have more
than 8 Active
ingredients)
5.
6.
7.
8.
Inactive Ingredients
Inactive Ingredient
(eg. Water )
Strength
(Optional)
UNII
(if known)
(Unique Ingredient Identifier)
Please list All
Inactive
Ingredients,
and UNII (if
known)
Strength is
optional
1.
2.
3.
4.
(please use
additional form
if you have
more Inactive
Ingredients)
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
Other Informations (if any)
I agree to the above Terms and Conditions
Submitter Name
Job Title
Submitter E-mail
