Pentasa - 54092-191-08 - (mesalamine)

Alphabetical Index


Drug Information of Pentasa

Product NDC: 54092-191
Proprietary Name: Pentasa
Non Proprietary Name: mesalamine
Active Ingredient(s): 500    mg/1 & nbsp;   mesalamine
Administration Route(s): ORAL
Dosage Form(s): CAPSULE
Coding System: National Drug Codes(NDC)

Labeler Information of Pentasa

Product NDC: 54092-191
Labeler Name: Shire US Manufacturing Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA020049
Marketing Category: NDA
Start Marketing Date: 20040708

Package Information of Pentasa

Package NDC: 54092-191-08
Package Description: 8 CAPSULE in 1 CARTON (54092-191-08)

NDC Information of Pentasa

NDC Code 54092-191-08
Proprietary Name Pentasa
Package Description 8 CAPSULE in 1 CARTON (54092-191-08)
Product NDC 54092-191
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name mesalamine
Dosage Form Name CAPSULE
Route Name ORAL
Start Marketing Date 20040708
Marketing Category Name NDA
Labeler Name Shire US Manufacturing Inc.
Substance Name MESALAMINE
Strength Number 500
Strength Unit mg/1
Pharmaceutical Classes Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient]

Complete Information of Pentasa


General Information