FDA.reportPublic FDA data

amylase 42000 UNT / lipase 10000 UNT / protease 32000 UNT Delayed Release Oral Capsule [Zenpep]

RxCUI
1595462
RxNorm name
amylase 42000 UNT / lipase 10000 UNT / protease 32000 UNT Delayed Release Oral Capsule [Zenpep]
Display name
amylase 42000 UNT / lipase 10000 UNT / protease 32000 UNT Delayed Release Oral Capsule [Zenpep]
Full name
amylase 42000 UNT / lipase 10000 UNT / protease 32000 UNT Delayed Release Oral Capsule [Zenpep]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:05

Purple Book Biologic Products#

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

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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
rxcui: 1595462

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
7f16f2d4-8df6-4bd7-ac10-56994fa257b0amylase 42000 UNT / lipase 10000 UNT / protease 32000 UNT Delayed Release Oral Capsule [Zenpep]SBD8These 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, for oral use Initial U.S. Approval: 200920251114
7f16f2d4-8df6-4bd7-ac10-56994fa257b0Zenpep (lipase 10,000 UNT / amylase 42,000 UNT / protease 32,000 UNT) Delayed Release Oral CapsuleSY8These 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, for oral use Initial U.S. Approval: 200920251114
7f16f2d4-8df6-4bd7-ac10-56994fa257b0Zenpep (amylases 42,000 UNT / endopeptidases 32,000 UNT / lipase 10,000 UNT) Delayed Release Oral CapsuleSY8These 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, for oral use Initial U.S. Approval: 200920251114
7f16f2d4-8df6-4bd7-ac10-56994fa257b0Zenpep 10,000 UNT / 42,000 UNT / 32,000 UNT Delayed Release Oral CapsulePSN8These 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, for oral use Initial U.S. Approval: 200920251114