Asacol HD - 0149-0783-01 - (mesalamine)

Alphabetical Index


Drug Information of Asacol HD

Product NDC: 0149-0783
Proprietary Name: Asacol HD
Non Proprietary Name: mesalamine
Active Ingredient(s): 800    mg/1 & nbsp;   mesalamine
Administration Route(s): ORAL
Dosage Form(s): TABLET, DELAYED RELEASE
Coding System: National Drug Codes(NDC)

Labeler Information of Asacol HD

Product NDC: 0149-0783
Labeler Name: Procter & Gamble Pharmaceuticals, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA021830
Marketing Category: NDA
Start Marketing Date: 20090528

Package Information of Asacol HD

Package NDC: 0149-0783-01
Package Description: 180 TABLET, DELAYED RELEASE in 1 BOTTLE (0149-0783-01)

NDC Information of Asacol HD

NDC Code 0149-0783-01
Proprietary Name Asacol HD
Package Description 180 TABLET, DELAYED RELEASE in 1 BOTTLE (0149-0783-01)
Product NDC 0149-0783
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name mesalamine
Dosage Form Name TABLET, DELAYED RELEASE
Route Name ORAL
Start Marketing Date 20090528
Marketing Category Name NDA
Labeler Name Procter & Gamble Pharmaceuticals, Inc.
Substance Name MESALAMINE
Strength Number 800
Strength Unit mg/1
Pharmaceutical Classes Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient]

Complete Information of Asacol HD


General Information