FDA.reportPublic FDA data

amylase 24600 UNT / lipase 4200 UNT / protease 14200 UNT Delayed Release Oral Capsule

RxCUI
1806964
RxNorm name
amylase 24600 UNT / lipase 4200 UNT / protease 14200 UNT Delayed Release Oral Capsule
Display name
amylase 24600 UNT / lipase 4200 UNT / protease 14200 UNT Delayed Release Oral Capsule
Full name
amylase 24600 UNT / lipase 4200 UNT / protease 14200 UNT Delayed Release Oral Capsule
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:26

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
022523Pancreazepancrelipase351(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#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PANCREAZEPANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, AND PANCRELIPASE PROTEASEVIVUS LLCe8f5d2fe-728d-42af-99a6-83dddc6539c52025-06-06Warnings, Adverse reactionsExact identifier
rxcui: 1806964

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
e8f5d2fe-728d-42af-99a6-83dddc6539c5amylase 24600 UNT / lipase 4200 UNT / protease 14200 UNT Delayed Release Oral CapsuleSCD17These highlights do not include all the information needed to use PANCREAZE ® safely and effectively. See full prescribing information for PANCREAZE ® . PANCREAZE ® (pancrelipase) delayed-release capsules Initial U.S. Approval: 201020250606
e8f5d2fe-728d-42af-99a6-83dddc6539c5amylases 24,600 UNT / endopeptidases 14,200 UNT / lipase 4200 UNT Delayed Release Oral CapsuleSY17These highlights do not include all the information needed to use PANCREAZE ® safely and effectively. See full prescribing information for PANCREAZE ® . PANCREAZE ® (pancrelipase) delayed-release capsules Initial U.S. Approval: 201020250606
e8f5d2fe-728d-42af-99a6-83dddc6539c5amylase 24,600 UNT / lipase 4200 UNT / protease 14,200 UNT Delayed Release Oral CapsuleSY17These highlights do not include all the information needed to use PANCREAZE ® safely and effectively. See full prescribing information for PANCREAZE ® . PANCREAZE ® (pancrelipase) delayed-release capsules Initial U.S. Approval: 201020250606
e8f5d2fe-728d-42af-99a6-83dddc6539c5lipase 4200 UNT / amylase 24,600 UNT / protease 14,200 UNT Delayed Release Oral CapsulePSN17These highlights do not include all the information needed to use PANCREAZE ® safely and effectively. See full prescribing information for PANCREAZE ® . PANCREAZE ® (pancrelipase) delayed-release capsules Initial U.S. Approval: 201020250606