Home NDC 42865-304 ZENPEP
Product NDC 42865-304
11-digit product format 428650304
Labeler code 42865
Product ID 42865-304_c7f326d9-a87f-4412-8429-daa379ae9585
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name pancrelipase
Dosage form CAPSULE, DELAYED RELEASE
Route ORAL
Labeler Allergan, Inc.
Application NDA022210
Marketing category NDA
Marketing start 2009-09-22
Marketing end 2020-08-31
Substance PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE
Active strength 3000 [USP'U]/1; [USP'U]/1; [USP'U]/1
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PANCRELIPASE AMYLASE ACTIVE INGREDIENT YOJ58O116E ZENPEP (PANCRELIPASE) CAPSULE, DELAYED RELEASE [APTALIS PHARMA US, INC.] 17 PANCRELIPASE LIPASE ACTIVE INGREDIENT 8MYC33932O ZENPEP (PANCRELIPASE) CAPSULE, DELAYED RELEASE [APTALIS PHARMA US, INC.] 17 PANCRELIPASE PROTEASE ACTIVE INGREDIENT 3560D81V50 ZENPEP (PANCRELIPASE) CAPSULE, DELAYED RELEASE [APTALIS PHARMA US, INC.] 17 PANCRELIPASE AMYLASE ACTIVE MOIETY YOJ58O116E ZENPEP (PANCRELIPASE) CAPSULE, DELAYED RELEASE [APTALIS PHARMA US, INC.] 17 PANCRELIPASE LIPASE ACTIVE MOIETY 8MYC33932O ZENPEP (PANCRELIPASE) CAPSULE, DELAYED RELEASE [APTALIS PHARMA US, INC.] 17 PANCRELIPASE PROTEASE ACTIVE MOIETY 3560D81V50 ZENPEP (PANCRELIPASE) CAPSULE, DELAYED RELEASE [APTALIS PHARMA US, INC.] 17 CARRAGEENAN INACTIVE INGREDIENT 5C69YCD2YJ ZENPEP (PANCRELIPASE) CAPSULE, DELAYED RELEASE [APTALIS PHARMA US, INC.] 17 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ZENPEP (PANCRELIPASE) CAPSULE, DELAYED RELEASE [APTALIS PHARMA US, INC.] 17 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ZENPEP (PANCRELIPASE) CAPSULE, DELAYED RELEASE [APTALIS PHARMA US, INC.] 17 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ZENPEP (PANCRELIPASE) CAPSULE, DELAYED RELEASE [APTALIS PHARMA US, INC.] 17 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 ZENPEP (PANCRELIPASE) CAPSULE, DELAYED RELEASE [APTALIS PHARMA US, INC.] 17 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ZENPEP (PANCRELIPASE) CAPSULE, DELAYED RELEASE [APTALIS PHARMA US, INC.] 17 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ZENPEP (PANCRELIPASE) CAPSULE, DELAYED RELEASE [APTALIS PHARMA US, INC.] 17 HYDROGENATED CASTOR OIL INACTIVE INGREDIENT ZF94AP8MEY ZENPEP (PANCRELIPASE) CAPSULE, DELAYED RELEASE [APTALIS PHARMA US, INC.] 17 HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST) INACTIVE INGREDIENT 8LDD2V82F5 ZENPEP (PANCRELIPASE) CAPSULE, DELAYED RELEASE [APTALIS PHARMA US, INC.] 17 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ZENPEP (PANCRELIPASE) CAPSULE, DELAYED RELEASE [APTALIS PHARMA US, INC.] 17 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ZENPEP (PANCRELIPASE) CAPSULE, DELAYED RELEASE [APTALIS PHARMA US, INC.] 17 POTASSIUM CHLORIDE INACTIVE INGREDIENT 660YQ98I10 ZENPEP (PANCRELIPASE) CAPSULE, DELAYED RELEASE [APTALIS PHARMA US, INC.] 17 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ZENPEP (PANCRELIPASE) CAPSULE, DELAYED RELEASE [APTALIS PHARMA US, INC.] 17 TALC INACTIVE INGREDIENT 7SEV7J4R1U ZENPEP (PANCRELIPASE) CAPSULE, DELAYED RELEASE [APTALIS PHARMA US, INC.] 17 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ZENPEP (PANCRELIPASE) CAPSULE, DELAYED RELEASE [APTALIS PHARMA US, INC.] 17 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM ZENPEP (PANCRELIPASE) CAPSULE, DELAYED RELEASE [APTALIS PHARMA US, INC.] 17 WATER INACTIVE INGREDIENT 059QF0KO0R ZENPEP (PANCRELIPASE) CAPSULE, DELAYED RELEASE [APTALIS PHARMA US, INC.] 17