Zenpep (Page 6 of 6)

PRINCIPAL DISPLAY PANEL — Lipase 3,000 USP Units

Principal Display Panel -- Lipase 3,000 USP Units
(click image for full-size original)

Bottle Label NDC 73562-113-01

12480856 NDC 73562-113-01

Zenpep®
(pancrelipase)
Delayed-Release Capsules

Rx Only

DOSE BY LIPASE UNITS:
Lipase 3,000 USP units
Protease 10,000 USP unitsAmylase 14,000 USP units

Dispense enclosed Medication Guide to each patient

100 Delayed-Release Capsules

PRINCIPAL DISPLAY PANEL — Lipase 5,000 USP Units

Principal Display Panel -- Lipase 5,000 USP Units
(click image for full-size original)

Bottle Label NDC 73562-115-01

12480843 NDC 73562-115-01

Zenpep®
(pancrelipase)
Delayed-Release Capsules

Rx Only

DOSE BY LIPASE UNITS:
Lipase 5,000 USP units
Protease 17,000 USP unitsAmylase 24,000 USP units

Dispense enclosed Medication Guide to each patient

100 Delayed-Release Capsules

PRINCIPAL DISPLAY PANEL — Lipase 10,000 USP Units

Principal Display Panel -- Lipase 10,000 USP Units
(click image for full-size original)

Bottle Label NDC 73562-110-01

12480847 NDC 73562-110-01

Zenpep®
(pancrelipase)
Delayed-Release Capsules

Rx Only

DOSE BY LIPASE UNITS:
Lipase 10,000 USP units
Protease 32,000 USP unitsAmylase 42,000 USP units

Dispense enclosed Medication Guide to each patient

100 Delayed-Release Capsules

PRINCIPAL DISPLAY PANEL — Lipase 15,000 USP Units

Principal Display Panel -- Lipase 15,000 USP Units
(click image for full-size original)

Bottle Label NDC 73562-111-01

12408049 NDC 73562-111-01

Zenpep®
(pancrelipase)
Delayed-Release Capsules

Rx Only

DOSE BY LIPASE UNITS:
Lipase 15,000 USP units
Protease 47,000 USP unitsAmylase 63,000 USP units

Dispense enclosed Medication Guide to each patient

100 Delayed-Release Capsules

PRINCIPAL DISPLAY PANEL — Lipase 20,000 USP Units

Principal Display Panel -- Lipase 20,000 USP Units
(click image for full-size original)

Bottle Label NDC 73562-112-01

12480857 NDC 73562-112-01

Zenpep®
(pancrelipase)
Delayed-Release Capsules

Rx Only

DOSE BY LIPASE UNITS:
Lipase 20,000 USP units
Protease 63,000 USP unitsAmylase 84,000 USP units

Dispense enclosed Medication Guide to each patient

100 Delayed-Release Capsules

PRINCIPAL DISPLAY PANEL — Lipase 25,000 USP Units

Principal Display Panel -- Lipase 25,000 USP Units
(click image for full-size original)

Bottle Label NDC 73562-116-01

12480860 NDC 73562-116-01

Zenpep®
(pancrelipase)
Delayed-Release Capsules

Rx Only

DOSE BY LIPASE UNITS:
Lipase 25,000 USP units
Protease 79,000 USP unitsAmylase 105,000 USP units

Dispense enclosed Medication Guide to each patient

100 Delayed-Release Capsules

PRINCIPAL DISPLAY PANEL — Lipase 40,000 USP Units

Principal Display Panel -- Lipase 40,000 USP Units
(click image for full-size original)

Bottle Label NDC 73562-114-01

12480870 NDC 73562-114-01

Zenpep®
(pancrelipase)
Delayed-Release Capsules

Rx Only

DOSE BY LIPASE UNITS:
Lipase 40,000 USP units
Protease 126,000 USP unitsAmylase 168,000 USP units

Dispense enclosed Medication Guide to each patient

100 Delayed-Release Capsules

ZENPEP pancrelipase lipase, pancrelipase protease, pancrelipase amylase capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:73562-113
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
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
TALC
TRIETHYL CITRATE
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)
CARRAGEENAN
POTASSIUM CHLORIDE
TITANIUM DIOXIDE
HYPROMELLOSE, UNSPECIFIED
WATER
Product Characteristics
Color WHITE (White, White) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code APTALIS;3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73562-113-01 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
2 NDC:73562-113-10 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA022210 01/01/2021
ZENPEP pancrelipase lipase, pancrelipase protease, pancrelipase amylase capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:73562-115
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
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
TALC
TRIETHYL CITRATE
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)
CARRAGEENAN
POTASSIUM CHLORIDE
TITANIUM DIOXIDE
HYPROMELLOSE, UNSPECIFIED
WATER
Product Characteristics
Color WHITE (White, White) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code APTALIS;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73562-115-01 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
2 NDC:73562-115-10 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA022210 01/01/2021
ZENPEP pancrelipase lipase, pancrelipase protease, pancrelipase amylase capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:73562-110
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
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
TALC
TRIETHYL CITRATE
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)
CARRAGEENAN
POTASSIUM CHLORIDE
TITANIUM DIOXIDE
HYPROMELLOSE, UNSPECIFIED
WATER
Product Characteristics
Color YELLOW (Yellow, White) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code APTALIS;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73562-110-01 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
2 NDC:73562-110-10 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA022210 01/01/2021
ZENPEP pancrelipase lipase, pancrelipase protease, pancrelipase amylase capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:73562-111
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
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
TALC
TRIETHYL CITRATE
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)
CARRAGEENAN
POTASSIUM CHLORIDE
TITANIUM DIOXIDE
HYPROMELLOSE, UNSPECIFIED
WATER
Product Characteristics
Color RED (Red, White) Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code APTALIS;15
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73562-111-01 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA022210 12/01/2020
ZENPEP pancrelipase lipase, pancrelipase protease, pancrelipase amylase capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:73562-112
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
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
TALC
TRIETHYL CITRATE
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)
CARRAGEENAN
POTASSIUM CHLORIDE
TITANIUM DIOXIDE
HYPROMELLOSE, UNSPECIFIED
WATER
Product Characteristics
Color GREEN (Green, White) Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code APTALIS;20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73562-112-01 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA022210 12/01/2020
ZENPEP pancrelipase lipase, pancrelipase protease, pancrelipase amylase capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:73562-116
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
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
TALC
TRIETHYL CITRATE
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)
CARRAGEENAN
POTASSIUM CHLORIDE
TITANIUM DIOXIDE
HYPROMELLOSE, UNSPECIFIED
WATER
Product Characteristics
Color BLUE (Blue, White) Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code APTALIS;25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73562-116-01 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
2 NDC:73562-116-12 12 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA022210 11/01/2020
ZENPEP pancrelipase lipase, pancrelipase protease, pancrelipase amylase capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:73562-114
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
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
TALC
TRIETHYL CITRATE
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)
CARRAGEENAN
POTASSIUM CHLORIDE
TITANIUM DIOXIDE
HYPROMELLOSE, UNSPECIFIED
WATER
Product Characteristics
Color ORANGE (Orange, White) Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code APTALIS;40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73562-114-01 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
2 NDC:73562-114-12 12 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA022210 11/01/2020
Labeler — Nestle Healthcare Nutrition, Inc. (006247332)
Registrant — Zenpep, LLC (117366363)

Revised: 11/2021 Nestle Healthcare Nutrition, Inc.

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