Viokace (Page 4 of 4)

PRINCIPAL DISPLAY PANEL — Lipase 10,440 USP Units

Principal Display Panel -- Lipase 10,440 USP Units
(click image for full-size original)

Bottle Label NDC 73562-104-10

Rx only

NDC# 73562-104 -10

Viokace®
(pancrelipase)
Tablets

Each tablet contains:
10,440 USP Units Lipase
39,150 USP Units Amylase
39,150 USP Units Protease

VIOKACE® is dosed based
on lipase units

100 TABLETS

VIOKACE® tablets should be
swallowed whole. Do not crush
or chew tablets.

Dispense the enclosed Medication Guide to each patient.

PRINCIPAL DISPLAY PANEL — Lipase 20,880 USP Units

Principal Display Panel -- Lipase 20,880 USP Units
(click image for full-size original)

Bottle Label NDC 73562-208-10

Rx only

NDC# 73562-208 -10

Viokace®
(pancrelipase)
Tablets

Each tablet contains:
20,880 USP Units Lipase
78,300 USP Units Amylase
78,330 USP Units Protease

VIOKACE® is dosed based
on lipase units

100 TABLETS

VIOKACE® tablets should be
swallowed whole. Do not crush
or chew tablets.

Dispense the enclosed Medication Guide to each patient.

VIOKACE pancrelipase tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:73562-104
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PANCRELIPASE LIPASE (PANCRELIPASE LIPASE) PANCRELIPASE LIPASE 10440 [USP’U]
PANCRELIPASE PROTEASE (PANCRELIPASE PROTEASE) PANCRELIPASE PROTEASE 39150 [USP’U]
PANCRELIPASE AMYLASE (PANCRELIPASE AMYLASE) PANCRELIPASE AMYLASE 39150 [USP’U]
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
CROSCARMELLOSE SODIUM
STEARIC ACID
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
TALC
Product Characteristics
Color BROWN (Tan) Score no score
Shape ROUND (Biconvex) Size 13mm
Flavor Imprint Code VIO9111;9111
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73562-104-10 1 BOTTLE in 1 CARTON contains a BOTTLE
1 100 TABLET in 1 BOTTLE This package is contained within the CARTON (73562-104-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA022542 03/01/2021
VIOKACE pancrelipase tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:73562-208
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PANCRELIPASE LIPASE (PANCRELIPASE LIPASE) PANCRELIPASE LIPASE 20880 [USP’U]
PANCRELIPASE PROTEASE (PANCRELIPASE PROTEASE) PANCRELIPASE PROTEASE 78300 [USP’U]
PANCRELIPASE AMYLASE (PANCRELIPASE AMYLASE) PANCRELIPASE AMYLASE 78300 [USP’U]
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
CROSCARMELLOSE SODIUM
STEARIC ACID
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
TALC
Product Characteristics
Color BROWN (Tan) Score no score
Shape OVAL (Biconvex) Size 19mm
Flavor Imprint Code V16;9116
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73562-208-10 1 BOTTLE in 1 CARTON contains a BOTTLE
1 100 TABLET in 1 BOTTLE This package is contained within the CARTON (73562-208-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA022542 03/01/2021
Labeler — Aimmune Therapeutics, Inc (057562771)

Revised: 02/2024 Aimmune Therapeutics, Inc

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