ZENPEP
These highlights do not include all the information needed to use ZENPEP safely and effectively. See full prescribing information for ZENPEP. ZENPEP (pancrelipase) delayed release capsules Initial U.S. Approval: 2009
Approved
Approval ID
c6c845b3-8f22-454e-b0f8-ed2cdd59e8dd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 15, 2014
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
pancrelipase
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6435
Application NumberNDA022210
Product Classification
M
Marketing Category
C73594
G
Generic Name
pancrelipase
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 15, 2014
FDA Product Classification
INGREDIENTS (17)
PANCRELIPASE PROTEASEActive
Quantity: 34000 [USP'U] in 1 1
Code: 3560D81V50
Classification: ACTIB
PANCRELIPASE LIPASEActive
Quantity: 10000 [USP'U] in 1 1
Code: 8MYC33932O
Classification: ACTIB
PANCRELIPASE AMYLASEActive
Quantity: 55000 [USP'U] in 1 1
Code: YOJ58O116E
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)Inactive
Code: 8LDD2V82F5
Classification: IACT
CARRAGEENANInactive
Code: 5C69YCD2YJ
Classification: IACT
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT