ZENPEP - 42865-104-01 - (pancrelipase)

Alphabetical Index


Drug Information of ZENPEP

Product NDC: 42865-104
Proprietary Name: ZENPEP
Non Proprietary Name: pancrelipase
Active Ingredient(s): 16000; 3000; 10000    [USP'U]/1; [USP'U]/1; [USP'U]/1 & nbsp;   pancrelipase
Administration Route(s): ORAL
Dosage Form(s): CAPSULE, DELAYED RELEASE
Coding System: National Drug Codes(NDC)

Labeler Information of ZENPEP

Product NDC: 42865-104
Labeler Name: Aptalis Pharma US, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA022210
Marketing Category: NDA
Start Marketing Date: 20090922

Package Information of ZENPEP

Package NDC: 42865-104-01
Package Description: 12 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS (42865-104-01)

NDC Information of ZENPEP

NDC Code 42865-104-01
Proprietary Name ZENPEP
Package Description 12 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS (42865-104-01)
Product NDC 42865-104
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name pancrelipase
Dosage Form Name CAPSULE, DELAYED RELEASE
Route Name ORAL
Start Marketing Date 20090922
Marketing Category Name NDA
Labeler Name Aptalis Pharma US, Inc.
Substance Name PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE
Strength Number 16000; 3000; 10000
Strength Unit [USP'U]/1; [USP'U]/1; [USP'U]/1
Pharmaceutical Classes

Complete Information of ZENPEP


General Information