FDA.reportPublic FDA data

Viokace 10,440 UNT / 39,150 UNT / 39,150 UNT Oral Tablet

RxCUI
1247388
RxNorm name
Viokace 10,440 UNT / 39,150 UNT / 39,150 UNT Oral Tablet
Display name
Viokace 10,440 UNT / 39,150 UNT / 39,150 UNT Oral Tablet
Full name
Viokace 10,440 UNT / 39,150 UNT / 39,150 UNT Oral Tablet
Term type
PSN
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: 1247388

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
58bdb8de-582d-44e6-9b72-8d5a42fdf501Viokace 10,440 UNT / 39,150 UNT / 39,150 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 39150 UNT / lipase 10440 UNT / protease 39150 UNT Oral Tablet [Viokace]SBD7These 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-44e6-9b72-8d5a42fdf501Viokase 10 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-44e6-9b72-8d5a42fdf501Viokace 10 (amylase 39,150 UNT / lipase 10,440 UNT / protease 39,150 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-44e6-9b72-8d5a42fdf501Viokase 20 (amylases 39,150 UNT / endopeptidases 39,150 UNT / lipase 10,440 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