Basic Information
ZENPEP
54868-6435
Regulatory Information
54868-6435
NDA022210
C73594
September 15, 2014
USA
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
HUMAN PRESCRIPTION DRUG LABEL
1
Company Information
194123980
Active Ingredients
CROSCARMELLOSE SODIUM
Code: M28OL1HH48
Class Code: IACT
HYDROGENATED CASTOR OIL
Code: ZF94AP8MEY
Class Code: IACT
SILICON DIOXIDE
Code: ETJ7Z6XBU4
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
TALC
Code: 7SEV7J4R1U
Class Code: IACT
CELLULOSE, MICROCRYSTALLINE
Code: OP1R32D61U
Class Code: IACT
TRIETHYL CITRATE
Code: 8Z96QXD6UM
Class Code: IACT
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)
Code: 8LDD2V82F5
Class Code: IACT
CARRAGEENAN
Code: 5C69YCD2YJ
Class Code: IACT
POTASSIUM CHLORIDE
Code: 660YQ98I10
Class Code: IACT
FERRIC OXIDE YELLOW
Code: EX438O2MRT
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
WATER
Code: 059QF0KO0R
Class Code: IACT
HYPROMELLOSES
Code: 3NXW29V3WO
Class Code: IACT
Active Moieties
PANCRELIPASE PROTEASE
Code: 3560D81V50
PANCRELIPASE LIPASE
Code: 8MYC33932O
PANCRELIPASE AMYLASE
Code: YOJ58O116E