Zenpep (Page 6 of 6)

PRINCIPAL DISPLAY PANEL

NDC 0023-6113-01
ZENPEP®
(Pancrelipase)
Delayed-Release Capsules
Lipase 3,000 USP units
Protease 10,000 USP units
Amylase 14,000 USP units
100 Delayed-Release CapsulesRx Only

PRINCIPAL DISPLAY PANEL
NDC 0023-6113-01
ZENPEP® 
(Pancrelipase) 
Delayed-Release Capsules
Lipase 3,000 USP units
Protease 10,000 USP units
Amylase 14,000 USP units
100 Delayed-Release Capsules
Rx Only
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0023-6115-01
ZENPEP®
(Pancrelipase)
Delayed-Release Capsules
Lipase 5,000 USP units
Protease 17,000 USP units
Amylase 24,000 USP units
100 Delayed-Release CapsulesRx Only

PRINCIPAL DISPLAY PANEL
NDC 0023-6115-01
ZENPEP® 
(Pancrelipase)
Delayed-Release Capsules
Lipase 5,000 USP units
Protease 17,000 USP units
Amylase 24,000 USP units
100 Delayed-Release Capsules
Rx Only
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0023-6110-01
ZENPEP®
(Pancrelipase)
Delayed-Release Capsules
Lipase 10,000 USP units
Protease 32,000 USP units
Amylase 42,000 USP units
100 Delayed-Release CapsulesRx Only

PRINCIPAL DISPLAY PANEL
NDC 0023-6110-01
ZENPEP® 
(Pancrelipase)
Delayed-Release Capsules
Lipase 10,000 USP units
Protease 32,000 USP units
Amylase 42,000 USP units
100 Delayed-Release Capsules
Rx Only
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0023-6111-01
ZENPEP®
(Pancrelipase)
Delayed-Release Capsules
Lipase 15,000 USP units
Protease 47,000 USP units
Amylase 63,000 USP units
100 Delayed-Release CapsulesRx Only

PRINCIPAL DISPLAY PANEL
NDC 0023-6111-01
ZENPEP® 
(Pancrelipase)
Delayed-Release Capsules
Lipase 15,000 USP units
Protease 47,000 USP units
Amylase 63,000 USP units
100 Delayed-Release Capsules
Rx Only
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0023-6112-01
ZENPEP®
(Pancrelipase)
Delayed-Release Capsules
Lipase 20,000 USP units
Protease 63,000 USP units
Amylase 84,000 USP units
100 Delayed-Release CapsulesRx Only

PRINCIPAL DISPLAY PANEL
NDC 0023-6112-01
ZENPEP® 
(Pancrelipase)
Delayed-Release Capsules
Lipase 20,000 USP units
Protease 63,000 USP units
Amylase 84,000 USP units
100 Delayed-Release Capsules
Rx Only
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0023-6116-01
ZENPEP®
(Pancrelipase)
Delayed-Release Capsules
Lipase 25,000 USP units
Protease 79,000 USP units
Amylase 105,000 USP units
100 Delayed-Release CapsulesRx Only

PRINCIPAL DISPLAY PANEL
NDC 0023-6116-01
ZENPEP® 
(Pancrelipase)
Delayed-Release Capsules
Lipase 25,000 USP units
Protease 79,000 USP units
Amylase 105,000 USP units
100 Delayed-Release Capsules
Rx Only
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0023-6114-01
ZENPEP®
(Pancrelipase)
Delayed-Release Capsules
Lipase 40,000 USP units
Protease 126,000 USP units
Amylase 168,000 USP units
100 Delayed-Release CapsulesRx Only

PRINCIPAL DISPLAY PANEL
NDC 0023-6114-01
ZENPEP® 
(Pancrelipase)
Delayed-Release Capsules
Lipase 40,000 USP units
Protease 126,000 USP units
Amylase 168,000 USP units
100 Delayed-Release Capsules
Rx Only
(click image for full-size original)
ZENPEP pancrelipase lipase, pancrelipase protease, pancrelipase amylase capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0023-6113
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PANCRELIPASE LIPASE (PANCRELIPASE LIPASE) PANCRELIPASE LIPASE 3000 [USP’U]
PANCRELIPASE PROTEASE (PANCRELIPASE PROTEASE) PANCRELIPASE PROTEASE 10000 [USP’U]
PANCRELIPASE AMYLASE (PANCRELIPASE AMYLASE) PANCRELIPASE AMYLASE 14000 [USP’U]
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
HYDROGENATED CASTOR OIL
SILICON DIOXIDE
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
TALC
TRIETHYL CITRATE
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)
CARRAGEENAN
POTASSIUM CHLORIDE
TITANIUM DIOXIDE
HYPROMELLOSES
WATER
Product Characteristics
Color WHITE (white) , WHITE (white) Score no score
Shape CAPSULE (CAPSULE) Size 14mm
Flavor Imprint Code APTALIS;3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0023-6113-01 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA022210 10/31/2017
ZENPEP pancrelipase lipase, pancrelipase protease, pancrelipase amylase capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0023-6115
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PANCRELIPASE LIPASE (PANCRELIPASE LIPASE) PANCRELIPASE LIPASE 5000 [USP’U]
PANCRELIPASE PROTEASE (PANCRELIPASE PROTEASE) PANCRELIPASE PROTEASE 17000 [USP’U]
PANCRELIPASE AMYLASE (PANCRELIPASE AMYLASE) PANCRELIPASE AMYLASE 24000 [USP’U]
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
HYDROGENATED CASTOR OIL
SILICON DIOXIDE
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
TALC
TRIETHYL CITRATE
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)
CARRAGEENAN
POTASSIUM CHLORIDE
TITANIUM DIOXIDE
HYPROMELLOSES
WATER
Product Characteristics
Color WHITE (white) , WHITE (white) Score no score
Shape CAPSULE (CAPSULE) Size 14mm
Flavor Imprint Code APTALIS;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0023-6115-01 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA022210 10/13/2017
ZENPEP pancrelipase lipase, pancrelipase protease, pancrelipase amylase capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0023-6110
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PANCRELIPASE LIPASE (PANCRELIPASE LIPASE) PANCRELIPASE LIPASE 10000 [USP’U]
PANCRELIPASE PROTEASE (PANCRELIPASE PROTEASE) PANCRELIPASE PROTEASE 32000 [USP’U]
PANCRELIPASE AMYLASE (PANCRELIPASE AMYLASE) PANCRELIPASE AMYLASE 42000 [USP’U]
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
HYDROGENATED CASTOR OIL
SILICON DIOXIDE
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
TALC
TRIETHYL CITRATE
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)
CARRAGEENAN
POTASSIUM CHLORIDE
TITANIUM DIOXIDE
HYPROMELLOSES
WATER
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW (yellow) , WHITE (white) Score no score
Shape CAPSULE (CAPSULE) Size 18mm
Flavor Imprint Code APTALIS;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0023-6110-01 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA022210 10/31/2017
ZENPEP pancrelipase lipase, pancrelipase protease, pancrelipase amylase capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0023-6111
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PANCRELIPASE LIPASE (PANCRELIPASE LIPASE) PANCRELIPASE LIPASE 15000 [USP’U]
PANCRELIPASE PROTEASE (PANCRELIPASE PROTEASE) PANCRELIPASE PROTEASE 47000 [USP’U]
PANCRELIPASE AMYLASE (PANCRELIPASE AMYLASE) PANCRELIPASE AMYLASE 63000 [USP’U]
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
HYDROGENATED CASTOR OIL
SILICON DIOXIDE
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
TALC
TRIETHYL CITRATE
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)
CARRAGEENAN
POTASSIUM CHLORIDE
TITANIUM DIOXIDE
HYPROMELLOSES
WATER
FERRIC OXIDE RED
Product Characteristics
Color RED (red) , WHITE (white) Score no score
Shape CAPSULE (CAPSULE) Size 22mm
Flavor Imprint Code APTALIS;15
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0023-6111-01 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA022210 10/06/2017
ZENPEP pancrelipase lipase, pancrelipase protease, pancrelipase amylase capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0023-6112
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PANCRELIPASE LIPASE (PANCRELIPASE LIPASE) PANCRELIPASE LIPASE 20000 [USP’U]
PANCRELIPASE PROTEASE (PANCRELIPASE PROTEASE) PANCRELIPASE PROTEASE 63000 [USP’U]
PANCRELIPASE AMYLASE (PANCRELIPASE AMYLASE) PANCRELIPASE AMYLASE 84000 [USP’U]
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
HYDROGENATED CASTOR OIL
SILICON DIOXIDE
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
TALC
TRIETHYL CITRATE
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)
CARRAGEENAN
POTASSIUM CHLORIDE
TITANIUM DIOXIDE
HYPROMELLOSES
WATER
FERRIC OXIDE YELLOW
FD&C BLUE NO. 2
Product Characteristics
Color GREEN (green) , WHITE (white) Score no score
Shape CAPSULE (CAPSULE) Size 22mm
Flavor Imprint Code APTALIS;20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0023-6112-01 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA022210 08/26/2017
ZENPEP pancrelipase lipase, pancrelipase protease, pancrelipase amylase capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0023-6116
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PANCRELIPASE LIPASE (PANCRELIPASE LIPASE) PANCRELIPASE LIPASE 25000 [USP’U]
PANCRELIPASE PROTEASE (PANCRELIPASE PROTEASE) PANCRELIPASE PROTEASE 79000 [USP’U]
PANCRELIPASE AMYLASE (PANCRELIPASE AMYLASE) PANCRELIPASE AMYLASE 105000 [USP’U]
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
HYDROGENATED CASTOR OIL
SILICON DIOXIDE
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
TALC
TRIETHYL CITRATE
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)
CARRAGEENAN
POTASSIUM CHLORIDE
TITANIUM DIOXIDE
HYPROMELLOSES
WATER
FD&C BLUE NO. 2
Product Characteristics
Color BLUE (blue) , WHITE (white) Score no score
Shape CAPSULE (CAPSULE) Size 22mm
Flavor Imprint Code APTALIS;25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0023-6116-01 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA022210 10/06/2017
ZENPEP pancrelipase lipase, pancrelipase protease, pancrelipase amylase capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0023-6114
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PANCRELIPASE LIPASE (PANCRELIPASE LIPASE) PANCRELIPASE LIPASE 40000 [USP’U]
PANCRELIPASE PROTEASE (PANCRELIPASE PROTEASE) PANCRELIPASE PROTEASE 126000 [USP’U]
PANCRELIPASE AMYLASE (PANCRELIPASE AMYLASE) PANCRELIPASE AMYLASE 168000 [USP’U]
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
HYDROGENATED CASTOR OIL
SILICON DIOXIDE
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
TALC
TRIETHYL CITRATE
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)
CARRAGEENAN
POTASSIUM CHLORIDE
TITANIUM DIOXIDE
HYPROMELLOSES
WATER
FD&C YELLOW NO. 6
Product Characteristics
Color ORANGE (orange) , WHITE (white) Score no score
Shape CAPSULE (CAPSULE) Size 22mm
Flavor Imprint Code APTALIS;40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0023-6114-01 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA022210 10/15/2017
Labeler — Allergan, Inc. (144796497)

Revised: 03/2020 Allergan, Inc.

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