Viokace

Product NDC: 58914-117
11-digit product format: 589140117
Labeler code: 58914
Product ID: 58914-117_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: 20880 [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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	58914-117		D	Discontinued by firm		2026-08-17
excluded package	package	58914-117	58914-117-10	D	Discontinued by firm		2026-08-17

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58914-117-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58914-117-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58914-117-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58914-117-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58914-117-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58914-117-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58914-117-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58914-117-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58914-117-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	58914-117-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	58914-117-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	58914-117-10	`557ba5c1ecfa…`	`9c80585c8c6e…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58914-117-10	2023-02-02	C162847	48780-1	f386c649-e2f9-0266-e053-dadaa90a7c1a	These 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
58914-117-10	2023-01-30	C162847	48780-1	f386c649-e2f9-0266-e053-dadaa90a7c1a	These 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 NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58914-117-10	EA - Each	58914-117	67ecc1e4-6ce2-448b-b719-6c995f6c4d4b	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PANCRELIPASE AMYLASE	ACTIVE INGREDIENT	YOJ58O116E	VIOKACE (PANCRELIPASE) TABLET [APTALIS PHARMA US, INC]	3
PANCRELIPASE LIPASE	ACTIVE INGREDIENT	8MYC33932O	VIOKACE (PANCRELIPASE) TABLET [APTALIS PHARMA US, INC]	3
PANCRELIPASE PROTEASE	ACTIVE INGREDIENT	3560D81V50	VIOKACE (PANCRELIPASE) TABLET [APTALIS PHARMA US, INC]	3
PANCRELIPASE AMYLASE	ACTIVE MOIETY	YOJ58O116E	VIOKACE (PANCRELIPASE) TABLET [APTALIS PHARMA US, INC]	3
PANCRELIPASE LIPASE	ACTIVE MOIETY	8MYC33932O	VIOKACE (PANCRELIPASE) TABLET [APTALIS PHARMA US, INC]	3
PANCRELIPASE PROTEASE	ACTIVE MOIETY	3560D81V50	VIOKACE (PANCRELIPASE) TABLET [APTALIS PHARMA US, INC]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	VIOKACE (PANCRELIPASE) TABLET [APTALIS PHARMA US, INC]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	VIOKACE (PANCRELIPASE) TABLET [APTALIS PHARMA US, INC]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	VIOKACE (PANCRELIPASE) TABLET [APTALIS PHARMA US, INC]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	VIOKACE (PANCRELIPASE) TABLET [APTALIS PHARMA US, INC]	3
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	VIOKACE (PANCRELIPASE) TABLET [APTALIS PHARMA US, INC]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	VIOKACE (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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Viokace	PANCRELIPASE	Aimmune Therapeutics, Inc.	58bdb8de-582d-44e6-9b72-8d5a42fdf501	2025-08-14	Warnings, Adverse reactions	Exact identifier application number: BLA022542

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
022542	Viokace	pancrelipase	351(a)	Rx	2026-07-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8MYC33932O	PANCRELIPASE LIPASE	9001-62-1	PANCRELIPASE LIPASE
3560D81V50	PANCRELIPASE PROTEASE	9001-94-9	PANCRELIPASE PROTEASE
YOJ58O116E	PANCRELIPASE AMYLASE	9000-90-2	PANCRELIPASE AMYLASE
FQ3DRG0N5K	PANCRELIPASE	53608-75-6	Pancrelipase

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58914-117-10	58914011710	1 BOTTLE in 1 CARTON (58914-117-10) > 100 TABLET in 1 BOTTLE	1 bottle	2012-03-01	0000-00-00	No	No	Current