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)

Characteristics

* Route of Administration   Dosage Form
Flavor   Color
Shape   Size
Scoring
Imprint Informations   * Marketing Start DateSize
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)

Agreement for Drug Establishment Registration with US FDA

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It is a long established fact that a reader will be distracted by the readable content of a page when looking at its layout. The point of using Lorem Ipsum is that it has a more-or-less normal distribution of letters, as opposed to using 'Content here, content here', making it look like readable English. Many desktop publishing packages and web page editors now use Lorem Ipsum as their default model text, and a search for 'lorem ipsum' will uncover many web sites still in their infancy. Various versions have evolved over the years, sometimes by accident, sometimes on purpose (injected humour and the like).

It is a long established fact that a reader will be distracted by the readable content of a page when looking at its layout. The point of using Lorem Ipsum is that it has a more-or-less normal distribution of letters, as opposed to using 'Content here, content here', making it look like readable English. Many desktop publishing packages and web page editors now use Lorem Ipsum as their default model text, and a search for 'lorem ipsum' will uncover many web sites still in their infancy. Various versions have evolved over the years, sometimes by accident, sometimes on purpose (injected humour and the like).

It is a long established fact that a reader will be distracted by the readable content of a page when looking at its layout. The point of using Lorem Ipsum is that it has a more-or-less normal distribution of letters, as opposed to using 'Content here, content here', making it look like readable English. Many desktop publishing packages and web page editors now use Lorem Ipsum as their default model text, and a search for 'lorem ipsum' will uncover many web sites still in their infancy. Various versions have evolved over the years, sometimes by accident, sometimes on purpose (injected humour and the like).

Submitter name Job Title Submitter E-mail
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