PANCREAZE (Page 6 of 6)

PRINCIPAL DISPLAY PANEL — 100 Capsule Bottle Carton — NDC 62541-402-10

NDC 62541-402-10

pancrelipase
PANCREAZE ^®
Delayed-Release Capsules

Each capsule contains:

Lipase 4,200 USP Units
Amylase 24,600 USP Units
Protease 14,200 USP Units

DOSE BY LIPASE UNITS

Each delayed-release capsule
contains enteric coated pancrelipase
microtablets.
This product is of porcine origin.

Attention Pharmacist:
Dispense the accompanying
Medication Guide to each patient.

Rx only.

100
delayed-release capsules

PRINCIPAL DISPLAY PANEL — 100 Capsule Bottle Carton — NDC 62541-403-10

NDC 62541-403-10

pancrelipase
PANCREAZE ^®
Delayed-Release Capsules

Each capsule contains:

Lipase 10,500 USP Units
Amylase 61,500 USP Units
Protease 35,500 USP Units

DOSE BY LIPASE UNITS

Each delayed-release capsule contains
enteric coated pancrelipase microtablets.
This product is of porcine origin.

Attention Pharmacist:
Dispense the accompanying
Medication Guide to each patient.

Rx only.

100
delayed-release capsules

PRINCIPAL DISPLAY PANEL — 100 Capsule Bottle Carton — NDC 62541-404-10

NDC 62541-404-10

pancrelipase
PANCREAZE ^®
Delayed-Release Capsules

Each capsule contains:

Lipase 16,800 USP Units
Amylase 98,400 USP Units
Protease 56,800 USP Units

DOSE BY LIPASE UNITS

Each delayed-release capsule contains
enteric coated pancrelipase microtablets.
This product is of porcine origin.

Attention Pharmacist:
Dispense the accompanying
Medication Guide to each patient.

Rx only.

100
delayed-release capsules

PRINCIPAL DISPLAY PANEL — 100 Capsule Bottle Carton — NDC 62541-405-10

NDC 62541-405-10

pancrelipase
PANCREAZE ^®
Delayed-Release Capsules

Each capsule contains:

Lipase 21,000 USP Units
Amylase 83,900 USP Units
Protease 54,700 USP Units

DOSE BY LIPASE UNITS

Each delayed-release capsule contains
enteric coated pancrelipase microtablets.
This product is of porcine origin.

Attention Pharmacist:
Dispense the accompanying
Medication Guide to each patient.

Rx only.

100
delayed-release capsules

PRINCIPAL DISPLAY PANEL — 100 Capsule Bottle Carton — NDC 62541-401-10

NDC 62541-401-10

pancrelipase
PANCREAZE ^®
Delayed-Release Capsules

Each capsule contains:

Lipase 2,600 USP Units
Amylase 15,200 USP Units
Protease 8,800 USP Units

DOSE BY LIPASE UNITS

Each delayed-release capsule
contains enteric coated pancrelipase
microtablets.
This product is of porcine origin.

Attention Pharmacist:
Dispense the accompanying
Medication Guide to each patient.

Rx only.

100
delayed-release capsules

PRINCIPAL DISPLAY PANEL — 100 Capsule Bottle Carton — NDC 62541-406-10

NDC 62541-406-10
Contains 2 bottles of 50 delayed-release capsules in a carton

pancrelipase
PANCREAZE ^®
Delayed-Release Capsules

Each capsule contains:

Lipase 37,000 USP Units
Amylase 149,900 USP Units
Protease 97,300 USP Units

DOSE BY LIPASE UNITS

Each delayed-release capsule contains enteric coated
pancrelipase microtablets.
This product is of porcine origin.

Attention Pharmacist:
Dispense the accompanying Medication Guide to each patient.

Rx only.

100
delayed-release capsules

PANCREAZE pancrelipase lipase, pancrelipase amylase, and pancrelipase protease capsule, delayed release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62541-402 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PANCRELIPASE LIPASE (PANCRELIPASE LIPASE) PANCRELIPASE LIPASE 4200 [USP’U] PANCRELIPASE AMYLASE (PANCRELIPASE AMYLASE) PANCRELIPASE AMYLASE 24600 [USP’U] PANCRELIPASE PROTEASE (PANCRELIPASE PROTEASE) PANCRELIPASE PROTEASE 14200 [USP’U]

Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE CROSPOVIDONE (120 .MU.M) SILICON DIOXIDE MAGNESIUM STEARATE METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER TRIETHYL CITRATE TALC DIMETHICONE HYPROMELLOSE, UNSPECIFIED TITANIUM DIOXIDE SODIUM LAURYL SULFATE SORBITAN MONOLAURATE FERRIC OXIDE YELLOW SHELLAC AMMONIA PROPYLENE GLYCOL FERROSOFERRIC OXIDE

Product Characteristics Color yellow (Opaque) Score no score Shape CAPSULE Size 15mm Flavor Imprint Code VIVUS;MT;4 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:62541-402-10 1 BOTTLE, GLASS in 1 CARTON contains a BOTTLE, GLASS 1 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS This package is contained within the CARTON (62541-402-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA022523 04/12/2010

PANCREAZE pancrelipase lipase, pancrelipase amylase, and pancrelipase protease capsule, delayed release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62541-403 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PANCRELIPASE LIPASE (PANCRELIPASE LIPASE) PANCRELIPASE LIPASE 10500 [USP’U] PANCRELIPASE AMYLASE (PANCRELIPASE AMYLASE) PANCRELIPASE AMYLASE 61500 [USP’U] PANCRELIPASE PROTEASE (PANCRELIPASE PROTEASE) PANCRELIPASE PROTEASE 35500 [USP’U]

Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE CROSPOVIDONE (120 .MU.M) SILICON DIOXIDE MAGNESIUM STEARATE METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER TRIETHYL CITRATE TALC DIMETHICONE HYPROMELLOSE, UNSPECIFIED TITANIUM DIOXIDE SODIUM LAURYL SULFATE SORBITAN MONOLAURATE FERRIC OXIDE RED SHELLAC AMMONIA PROPYLENE GLYCOL FERROSOFERRIC OXIDE

Product Characteristics Color pink (Opaque) Score no score Shape CAPSULE Size 20mm Flavor Imprint Code VIVUS;MT;10 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:62541-403-10 1 BOTTLE, GLASS in 1 CARTON contains a BOTTLE, GLASS 1 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS This package is contained within the CARTON (62541-403-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA022523 04/12/2010

PANCREAZE pancrelipase lipase, pancrelipase amylase, and pancrelipase protease capsule, delayed release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62541-404 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PANCRELIPASE LIPASE (PANCRELIPASE LIPASE) PANCRELIPASE LIPASE 16800 [USP’U] PANCRELIPASE AMYLASE (PANCRELIPASE AMYLASE) PANCRELIPASE AMYLASE 98400 [USP’U] PANCRELIPASE PROTEASE (PANCRELIPASE PROTEASE) PANCRELIPASE PROTEASE 56800 [USP’U]

Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE CROSPOVIDONE (120 .MU.M) SILICON DIOXIDE MAGNESIUM STEARATE METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER TRIETHYL CITRATE TALC DIMETHICONE HYPROMELLOSE, UNSPECIFIED TITANIUM DIOXIDE SODIUM LAURYL SULFATE SORBITAN MONOLAURATE FERRIC OXIDE YELLOW SHELLAC AMMONIA PROPYLENE GLYCOL FERROSOFERRIC OXIDE

Product Characteristics Color orange (Salmon Opaque) Score no score Shape CAPSULE Size 22mm Flavor Imprint Code VIVUS;MT;16 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:62541-404-10 1 BOTTLE, GLASS in 1 CARTON contains a BOTTLE, GLASS 1 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS This package is contained within the CARTON (62541-404-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA022523 04/12/2010

PANCREAZE pancrelipase lipase, pancrelipase amylase, and pancrelipase protease capsule, delayed release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62541-405 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PANCRELIPASE LIPASE (PANCRELIPASE LIPASE) PANCRELIPASE LIPASE 21000 [USP’U] PANCRELIPASE AMYLASE (PANCRELIPASE AMYLASE) PANCRELIPASE AMYLASE 83900 [USP’U] PANCRELIPASE PROTEASE (PANCRELIPASE PROTEASE) PANCRELIPASE PROTEASE 54700 [USP’U]

Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE CROSPOVIDONE (120 .MU.M) SILICON DIOXIDE MAGNESIUM STEARATE METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER TRIETHYL CITRATE TALC DIMETHICONE HYPROMELLOSE, UNSPECIFIED TITANIUM DIOXIDE SODIUM LAURYL SULFATE SORBITAN MONOLAURATE FERRIC OXIDE YELLOW SHELLAC AMMONIA PROPYLENE GLYCOL

Product Characteristics Color white (Opaque) Score no score Shape CAPSULE Size 22mm Flavor Imprint Code VIVUS;MT;20 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:62541-405-10 1 BOTTLE, GLASS in 1 CARTON contains a BOTTLE, GLASS 1 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS This package is contained within the CARTON (62541-405-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA022523 04/12/2010

PANCREAZE pancrelipase lipase, pancrelipase amylase, and pancrelipase protease capsule, delayed release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62541-401 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PANCRELIPASE LIPASE (PANCRELIPASE LIPASE) PANCRELIPASE LIPASE 2600 [USP’U] PANCRELIPASE AMYLASE (PANCRELIPASE AMYLASE) PANCRELIPASE AMYLASE 15200 [USP’U] PANCRELIPASE PROTEASE (PANCRELIPASE PROTEASE) PANCRELIPASE PROTEASE 8800 [USP’U]

Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE CROSPOVIDONE (120 .MU.M) SILICON DIOXIDE MAGNESIUM STEARATE METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER TRIETHYL CITRATE TALC DIMETHICONE HYPROMELLOSE, UNSPECIFIED TITANIUM DIOXIDE FERRIC OXIDE YELLOW SHELLAC AMMONIA PROPYLENE GLYCOL DIPROPIONATE POTASSIUM HYDROXIDE FERRIC OXIDE RED PROPYLENE GLYCOL FERROSOFERRIC OXIDE

Product Characteristics Color orange (light orange opaque) Score no score Shape CAPSULE Size 15mm Flavor Imprint Code VIVUS;MT;2 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:62541-401-10 1 BOTTLE, GLASS in 1 CARTON contains a BOTTLE, GLASS 1 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS This package is contained within the CARTON (62541-401-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA022523 08/01/2016

PANCREAZE pancrelipase lipase, pancrelipase amylase, and pancrelipase protease capsule, delayed release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62541-406 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PANCRELIPASE LIPASE (PANCRELIPASE LIPASE) PANCRELIPASE LIPASE 37000 [USP’U] PANCRELIPASE AMYLASE (PANCRELIPASE AMYLASE) PANCRELIPASE AMYLASE 149900 [USP’U] PANCRELIPASE PROTEASE (PANCRELIPASE PROTEASE) PANCRELIPASE PROTEASE 97300 [USP’U]

Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE CROSPOVIDONE SILICON DIOXIDE MAGNESIUM STEARATE METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER TRIETHYL CITRATE TALC DIMETHICONE HYPROMELLOSE, UNSPECIFIED TITANIUM DIOXIDE SHELLAC AMMONIA PROPYLENE GLYCOL FERROSOFERRIC OXIDE

Product Characteristics Color gray (iron grey opaque body and white opaque cap) Score no score Shape CAPSULE Size 26mm Flavor Imprint Code VIVUS;MT;37 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:62541-406-10 2 BOTTLE, GLASS in 1 CARTON contains a BOTTLE, GLASS (62541-406-50) 1 NDC:62541-406-50 50 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS This package is contained within the CARTON (62541-406-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA022523 07/01/2021

Labeler — VIVUS LLC (782772263)

Establishment
Name	Address	ID/FEI	Operations
Nordmark Pharma GmbH		332430201	api manufacture (62541-401), api manufacture (62541-402), api manufacture (62541-403), api manufacture (62541-404), api manufacture (62541-405), api manufacture (62541-406), manufacture (62541-401), manufacture (62541-402), manufacture (62541-403), manufacture (62541-404), manufacture (62541-405), manufacture (62541-406), analysis (62541-401), analysis (62541-402), analysis (62541-403), analysis (62541-404), analysis (62541-405), analysis (62541-406)

Revised: 10/2022 VIVUS LLC