FDA.reportPublic FDA data

Zenpep

Product NDC
0023-6113
11-digit product format
000236113
Labeler code
0023
Product ID
0023-6113_af3d1aff-3b2e-46a3-b114-9208dec8c67d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Allergan, Inc.
Application
BLA022210
Marketing category
BLA
Marketing start
2017-10-31
Marketing end
0000-00-00
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
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0023-6113DDiscontinued by firm2026-07-31
excluded packagepackage0023-61130023-6113-01DDiscontinued by firm2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZenpepPANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASEAimmune Therapeutics, Inc.7f16f2d4-8df6-4bd7-ac10-56994fa257b02025-11-14Warnings, Adverse reactionsExact identifier
application number: BLA022210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0023-6113-012023-01-31C16284748780-1f386c64a-3790-0266-e053-dadaa90a7c1aThese 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-6113-01EA - Each0023-61137b7929ab-a7f2-47b7-9f04-78b6c59dcf8c12018-06-11

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
022210Zenpeppancrelipase351(a)Rx2026-06-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0023-6113-0100023611301100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS (0023-6113-01) 2017-10-310000-00-00NoNoCurrent