FDA.reportPublic FDA data

Viokace

Product NDC
73562-104
11-digit product format
735620104
Labeler code
73562
Product ID
73562-104_95ece3e2-a51f-4f4c-81ec-71aa2930a158
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pancrelipase
Dosage form
TABLET
Route
ORAL
Labeler
Aimmune Therapeutics, Inc.
Application
BLA022542
Marketing category
BLA
Marketing start
2021-03-01
Substance
PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE
Active strength
39150; 10440; 39150 [USP'U]/1; [USP'U]/1; [USP'U]/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Viokace
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PANCRELIPASE LIPASE39150 [USP'U]/1
PANCRELIPASE PROTEASE10440 [USP'U]/1
PANCRELIPASE AMYLASE39150 [USP'U]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8MYC33932OInternal UNII lookup
3560D81V50Internal UNII lookup
YOJ58O116EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1247379Internal RxNorm lookup
1247381Internal RxNorm lookup
1247386Internal RxNorm lookup
1247388Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
58bdb8de-582d-44e6-9b72-8d5a42fdf501Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b1603b8-969e-b082-f6f5-ad66d8a6ea8aProduct name220200325
19041f15-771b-3d3a-88fc-f5e2d079cd6dProduct name220200325
1987d950-08e4-4b70-adeb-fb67a71142abProduct name220200325
8825ddf7-1520-4680-b0ee-684e2fa73672Product name220200325
267a6f34-90b4-2f48-3063-4f505d06a7beProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73562-104-10Viokace100 in 1 BOTTLETABLET1007
73562-104-10Viokace1 in 1 CARTONTABLET17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73562-104-10EA - Each73562-1045c18e9ff-d65b-43f2-8dd3-8f1f7b7ea1e412021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73562-104VIOKACE (PANCRELIPASE) TABLET [AIMMUNE THERAPEUTICS, INC]4Current NDC, Legacy NDC, 2 package rows20240315_58bdb8de-582d-44e6-9b72-8d5a42fdf501.zip

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
ndc (product): 73562-104

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
022542Viokacepancrelipase351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1247386lipase 10,400 UNT / amylase 39,150 UNT / protease 39,150 UNT Oral TabletPSN58bdb8de-582d-44e6-9b72-8d5a42fdf5017
1247379lipase 20,880 UNT / amylase 78,300 UNT / protease 78,300 UNT Oral TabletPSN58bdb8de-582d-44e6-9b72-8d5a42fdf5017
1247388Viokace 10,440 UNT / 39,150 UNT / 39,150 UNT Oral TabletPSN58bdb8de-582d-44e6-9b72-8d5a42fdf5017
1247381Viokace 20,880 UNT / 78,300 UNT / 78,300 UNT Oral TabletPSN58bdb8de-582d-44e6-9b72-8d5a42fdf5017
1247388amylase 39150 UNT / lipase 10440 UNT / protease 39150 UNT Oral Tablet [Viokace]SBD58bdb8de-582d-44e6-9b72-8d5a42fdf5017
1247381amylase 78300 UNT / lipase 20880 UNT / protease 78300 UNT Oral Tablet [Viokace]SBD58bdb8de-582d-44e6-9b72-8d5a42fdf5017
1247386amylase 39150 UNT / lipase 10440 UNT / protease 39150 UNT Oral TabletSCD58bdb8de-582d-44e6-9b72-8d5a42fdf5017
1247379amylase 78300 UNT / lipase 20880 UNT / protease 78300 UNT Oral TabletSCD58bdb8de-582d-44e6-9b72-8d5a42fdf5017
1247386amylase 39,150 UNT / lipase 10,440 UNT / protease 39,150 UNT Oral TabletSY58bdb8de-582d-44e6-9b72-8d5a42fdf5017
1247379amylase 78,300 UNT / lipase 20,880 UNT / protease 78,300 UNT Oral TabletSY58bdb8de-582d-44e6-9b72-8d5a42fdf5017
1247386amylases 39,150 UNT / endopeptidases 39,150 UNT / lipase 10,440 UNT Oral TabletSY58bdb8de-582d-44e6-9b72-8d5a42fdf5017
1247379amylases 78,300 UNT / endopeptidases 78,300 UNT / lipase 20,880 UNT Oral TabletSY58bdb8de-582d-44e6-9b72-8d5a42fdf5017
1247388Viokace 10 (amylase 39,150 UNT / lipase 10,440 UNT / protease 39,150 UNT) Oral TabletSY58bdb8de-582d-44e6-9b72-8d5a42fdf5017
1247381Viokace 20 (amylase 78,300 UNT / lipase 20,880 UNT / protease 78,300 UNT) Oral TabletSY58bdb8de-582d-44e6-9b72-8d5a42fdf5017
1247388Viokase 10 Oral TabletSY58bdb8de-582d-44e6-9b72-8d5a42fdf5017
1247388Viokase 20 (amylases 39,150 UNT / endopeptidases 39,150 UNT / lipase 10,440 UNT) Oral TabletSY58bdb8de-582d-44e6-9b72-8d5a42fdf5017
1247381Viokase 20 (amylases 78,300 UNT / endopeptidases 78,300 UNT / lipase 20,880 UNT) Oral TabletSY58bdb8de-582d-44e6-9b72-8d5a42fdf5017
1247381Viokase 20 Oral TabletSY58bdb8de-582d-44e6-9b72-8d5a42fdf5017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73562-104-10735620104101 BOTTLE in 1 CARTON (73562-104-10) / 100 TABLET in 1 BOTTLE1 bottle2021-03-010000-00-00NoNoCurrent