MedPath
FDA Product

Zenpep

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

Basic Information

Zenpep

73562-116

Regulatory Information

73562-116

BLA022210

C73585

October 27, 2023

USA

These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 2009

HUMAN PRESCRIPTION DRUG LABEL

5

Company Information

057562771

Active Ingredients

PANCRELIPASE LIPASE

Quantity: 25000 [USP'U] in 1 1

Code: 8MYC33932O

Class Code: ACTIB

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

HYDROGENATED CASTOR OIL

Code: ZF94AP8MEY

Class Code: IACT

PANCRELIPASE AMYLASE

Quantity: 105000 [USP'U] in 1 1

Code: YOJ58O116E

Class Code: ACTIB

TALC

Code: 7SEV7J4R1U

Class Code: IACT

HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)

Code: 8LDD2V82F5

Class Code: IACT

POTASSIUM CHLORIDE

Code: 660YQ98I10

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

PANCRELIPASE PROTEASE

Quantity: 79000 [USP'U] in 1 1

Code: 3560D81V50

Class Code: ACTIB

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

CARRAGEENAN

Code: 5C69YCD2YJ

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

TRIETHYL CITRATE

Code: 8Z96QXD6UM

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

Active Moieties

PANCRELIPASE LIPASE

Code: 8MYC33932O

PANCRELIPASE AMYLASE

Code: YOJ58O116E

PANCRELIPASE PROTEASE

Code: 3560D81V50

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