MedPath
FDA Product

ZENPEP

Product approved by U.S. Food and Drug Administration (US)

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

PANCRELIPASE PROTEASE

Quantity: 34000 [USP'U] in 1 1

Code: 3560D81V50

Class Code: ACTIB

PANCRELIPASE LIPASE

Quantity: 10000 [USP'U] in 1 1

Code: 8MYC33932O

Class Code: ACTIB

PANCRELIPASE AMYLASE

Quantity: 55000 [USP'U] in 1 1

Code: YOJ58O116E

Class Code: ACTIB

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

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