FDA.reportPublic FDA data

Viokace

Product NDC
58914-112
Requested package NDC
58914-112-10
11-digit product format
589140112
Labeler code
58914
Product ID
58914-112_02cbdbc3-7d70-4f5f-afa4-5d16a15852fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pancrelipase
Dosage form
TABLET
Route
ORAL
Labeler
Allergan, Inc.
Application
BLA022542
Marketing category
BLA
Marketing start
2012-03-01
Marketing end
0000-00-00
Substance
PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE
Active strength
10440 [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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage58914-11258914-112-10DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58914-112-102023-02-02C16284748780-1f386c649-e2f9-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use VIOKACE safely and effectively. See full prescribing information for VIOKACE VIOKACE ® (pancrelipase) t ablets , for oral use Initial U.S. Approval: 2012
58914-112-102023-01-30C16284748780-1f386c649-e2f9-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use VIOKACE safely and effectively. See full prescribing information for VIOKACE VIOKACE ® (pancrelipase) t ablets , for oral use Initial U.S. Approval: 2012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58914-112-10EA - Each58914-1125ea4e0cb-3f2e-4703-bf06-ae6bdc6a11ed12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PANCRELIPASE AMYLASEACTIVE INGREDIENTYOJ58O116EVIOKACE (PANCRELIPASE) TABLET [APTALIS PHARMA US, INC]3
PANCRELIPASE LIPASEACTIVE INGREDIENT8MYC33932OVIOKACE (PANCRELIPASE) TABLET [APTALIS PHARMA US, INC]3
PANCRELIPASE PROTEASEACTIVE INGREDIENT3560D81V50VIOKACE (PANCRELIPASE) TABLET [APTALIS PHARMA US, INC]3
PANCRELIPASE AMYLASEACTIVE MOIETYYOJ58O116EVIOKACE (PANCRELIPASE) TABLET [APTALIS PHARMA US, INC]3
PANCRELIPASE LIPASEACTIVE MOIETY8MYC33932OVIOKACE (PANCRELIPASE) TABLET [APTALIS PHARMA US, INC]3
PANCRELIPASE PROTEASEACTIVE MOIETY3560D81V50VIOKACE (PANCRELIPASE) TABLET [APTALIS PHARMA US, INC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVIOKACE (PANCRELIPASE) TABLET [APTALIS PHARMA US, INC]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48VIOKACE (PANCRELIPASE) TABLET [APTALIS PHARMA US, INC]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XVIOKACE (PANCRELIPASE) TABLET [APTALIS PHARMA US, INC]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VIOKACE (PANCRELIPASE) TABLET [APTALIS PHARMA US, INC]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APVIOKACE (PANCRELIPASE) TABLET [APTALIS PHARMA US, INC]3
TALCINACTIVE INGREDIENT7SEV7J4R1UVIOKACE (PANCRELIPASE) TABLET [APTALIS PHARMA US, INC]3

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
application number: BLA022542

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
022542Viokacepancrelipase351(a)Rx2026-07-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58914-112-10589140112101 BOTTLE in 1 CARTON (58914-112-10) > 100 TABLET in 1 BOTTLE1 bottle2012-03-010000-00-00NoNoCurrent