PERTZYE (Page 5 of 5)

PRINCIPAL DISPLAY PANEL — 100 Capsule Bottle Label — 59767-008

100 Capsules
NDC 59767-008-01

pancrelipase
PERTZYE®

Rx Only

Delayed-Release Capsules

DOSE BY
LIPASE
UNITS

Lipase
8,000 USP Units

Protease
28,750 USP Units

Amylase
30,250 USP Units

Each delayed-release capsule contains pancrelipase
in bicarbonate-buffered enteric-coated microspheres.

This product is of porcine origin. No preservative.

PROFESSIONAL SAMPLE – NOT FOR RESALE Please read accompanying Medication Guide

PRINCIPAL DISPLAY PANEL -- 100 Capsule Bottle Label -- 59767-008
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 250 Capsule Bottle Label — 59767-008

250 Capsules
NDC 59767-008-02

pancrelipase
PERTZYE®

Rx Only

Delayed-Release Capsules

DOSE BY
LIPASE
UNITS

Lipase
8,000 USP Units

Protease
28,750 USP Units

Amylase
30,250 USP Units

Each delayed-release capsule contains pancrelipase
in bicarbonate-buffered enteric-coated microspheres.

This product is of porcine origin. No preservative.

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

PRINCIPAL DISPLAY PANEL -- 250 Capsule Bottle Label -- 59767-008
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 100 Capsule Bottle Label — 59767-004

100 Capsules
NDC 59767-004-01

pancrelipase
PERTZYE®

Rx Only

Delayed-Release Capsules

DOSE BY
LIPASE
UNITS

Lipase
4,000 USP Units

Protease
14,375 USP Units

Amylase
15,125 USP Units

Each delayed-release capsule contains pancrelipase
in bicarbonate-buffered enteric-coated microspheres.

This product is of porcine origin. No preservative.

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

PRINCIPAL DISPLAY PANEL -- 100 Capsule Bottle Label -- 59767-004
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 100 Capsule Bottle Label — 59767-016

100 Capsules
NDC 59767-016-01

pancrelipase
PERTZYE®

Rx Only

Delayed-Release Capsules

DOSE BY
LIPASE
UNITS

Lipase
16,000 USP Units

Protease
57,500 USP Units

Amylase
60,500 USP Units

Each delayed-release capsule contains pancrelipase
in bicarbonate-buffered enteric-coated microspheres.

This product is of porcine origin. No preservative.

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

PRINCIPAL DISPLAY PANEL -- 100 Capsule Bottle Label -- 59767-016
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 250 Capsule Bottle Label — 59767-016

250 Capsules
NDC 59767-016-02

pancrelipase
PERTZYE®

Rx Only

Delayed-Release Capsules

DOSE BY
LIPASE
UNITS

Lipase
16,000 USP Units

Protease
57,500 USP Units

Amylase
60,500 USP Units

Each delayed-release capsule contains pancrelipase
in bicarbonate-buffered enteric-coated microspheres.

This product is of porcine origin. No preservative.

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

PRINCIPAL DISPLAY PANEL -- 250 Capsule Bottle Label -- 59767-016
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 80 Capsule Bottle Label — 59767-024

80 Capsules
NDC 59767-024-01

pancrelipase
PERTZYE®

Rx Only

Delayed-Release Capsules

DOSE BY
LIPASE
UNITS

Lipase
24,000 USP Units

Protease
86,250 USP Units

Amylase
90,750 USP Units

Each delayed-release capsule contains pancrelipase
in bicarbonate-buffered enteric-coated microspheres.

This product is of porcine origin. No preservative.

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

PRINCIPAL DISPLAY PANEL -- 80 Capsule Bottle Label -- 59767-024
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 200 Capsule Bottle Label — 59767-024

200 Capsules
NDC 59767-024-02

pancrelipase
PERTZYE®

Rx Only

Delayed-Release Capsules

DOSE BY
LIPASE
UNITS

Lipase
24,000 USP Units

Protease
86,250 USP Units

Amylase
90,750 USP Units

Each delayed-release capsule contains pancrelipase
in bicarbonate-buffered enteric-coated microspheres.

This product is of porcine origin. No preservative.

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

PRINCIPAL DISPLAY PANEL -- 200 Capsule Bottle Label -- 59767-024
(click image for full-size original)
PERTZYE pancrelipase capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59767-008
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PANCRELIPASE LIPASE (PANCRELIPASE LIPASE) PANCRELIPASE LIPASE 8000 [USP’U]
PANCRELIPASE AMYLASE (PANCRELIPASE AMYLASE) PANCRELIPASE AMYLASE 30250 [USP’U]
PANCRELIPASE PROTEASE (PANCRELIPASE PROTEASE) PANCRELIPASE PROTEASE 28750 [USP’U]
Product Characteristics
Color blue (Clear capsule shell with blue band) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code DCI;8
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59767-008-01 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
2 NDC:59767-008-02 250 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA022175 05/17/2012
PERTZYE pancrelipase capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59767-004
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PANCRELIPASE LIPASE (PANCRELIPASE LIPASE) PANCRELIPASE LIPASE 4000 [USP’U]
PANCRELIPASE AMYLASE (PANCRELIPASE AMYLASE) PANCRELIPASE AMYLASE 15125 [USP’U]
PANCRELIPASE PROTEASE (PANCRELIPASE PROTEASE) PANCRELIPASE PROTEASE 14375 [USP’U]
Product Characteristics
Color green (Clear capsule shell with green band) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code DCI;4
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59767-004-01 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA022175 10/06/2016
PERTZYE pancrelipase capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59767-016
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PANCRELIPASE LIPASE (PANCRELIPASE LIPASE) PANCRELIPASE LIPASE 16000 [USP’U]
PANCRELIPASE AMYLASE (PANCRELIPASE AMYLASE) PANCRELIPASE AMYLASE 60500 [USP’U]
PANCRELIPASE PROTEASE (PANCRELIPASE PROTEASE) PANCRELIPASE PROTEASE 57500 [USP’U]
Product Characteristics
Color red (Clear capsule shell with red band) Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code DCI;16
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59767-016-01 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
2 NDC:59767-016-02 250 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA022175 05/17/2012
PERTZYE pancrelipase capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59767-024
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PANCRELIPASE LIPASE (PANCRELIPASE LIPASE) PANCRELIPASE LIPASE 24000 [USP’U]
PANCRELIPASE AMYLASE (PANCRELIPASE AMYLASE) PANCRELIPASE AMYLASE 90750 [USP’U]
PANCRELIPASE PROTEASE (PANCRELIPASE PROTEASE) PANCRELIPASE PROTEASE 86250 [USP’U]
Product Characteristics
Color purple (Clear capsule shell with purple band) Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code DCI;24
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59767-024-01 80 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
2 NDC:59767-024-02 200 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA022175 07/13/2017
Labeler — Digestive Care, Inc. (831065214)
Establishment
Name Address ID/FEI Operations
Digestive Care, Inc. 831065214 manufacture (59767-008), manufacture (59767-016), manufacture (59767-004), manufacture (59767-024)

Revised: 12/2022 Digestive Care, Inc.

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