FDA.reportPublic FDA data

amylases 78,300 UNT / endopeptidases 78,300 UNT / lipase 20,880 UNT Oral Tablet

RxCUI
1247379
RxNorm name
amylases 78,300 UNT / endopeptidases 78,300 UNT / lipase 20,880 UNT Oral Tablet
Display name
amylases 78,300 UNT / endopeptidases 78,300 UNT / lipase 20,880 UNT Oral Tablet
Full name
amylases 78,300 UNT / endopeptidases 78,300 UNT / lipase 20,880 UNT Oral Tablet
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:59

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
022542Viokacepancrelipase351(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
ViokacePANCRELIPASEAimmune Therapeutics, Inc.58bdb8de-582d-44e6-9b72-8d5a42fdf5012025-08-14Warnings, Adverse reactionsExact identifier
rxcui: 1247379

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
58bdb8de-582d-44e6-9b72-8d5a42fdf501amylases 78,300 UNT / endopeptidases 78,300 UNT / lipase 20,880 UNT Oral TabletSY7These highlights do not include all the information needed to use VIOKACE safely and effectively. See full prescribing information for VIOKACE VIOKACE ® (pancrelipase) tablets, for oral use Initial U.S. Approval: 201220250814
58bdb8de-582d-44e6-9b72-8d5a42fdf501amylase 78,300 UNT / lipase 20,880 UNT / protease 78,300 UNT Oral TabletSY7These highlights do not include all the information needed to use VIOKACE safely and effectively. See full prescribing information for VIOKACE VIOKACE ® (pancrelipase) tablets, for oral use Initial U.S. Approval: 201220250814
58bdb8de-582d-44e6-9b72-8d5a42fdf501lipase 20,880 UNT / amylase 78,300 UNT / protease 78,300 UNT Oral TabletPSN7These highlights do not include all the information needed to use VIOKACE safely and effectively. See full prescribing information for VIOKACE VIOKACE ® (pancrelipase) tablets, for oral use Initial U.S. Approval: 201220250814
58bdb8de-582d-44e6-9b72-8d5a42fdf501amylase 78300 UNT / lipase 20880 UNT / protease 78300 UNT Oral TabletSCD7These highlights do not include all the information needed to use VIOKACE safely and effectively. See full prescribing information for VIOKACE VIOKACE ® (pancrelipase) tablets, for oral use Initial U.S. Approval: 201220250814