Pantoprazole Sodium (Page 11 of 11)

PRINCIPAL DISPLAY PANEL – 20 mg

NDC 0378-6688-77

Pantoprazole Sodium
Delayed-Release
Tablets, USP
20 mg

Swallow tablets whole. Do NOT split,
chew, or crush tablets.

PHARMACIST: Dispense the accompanying
Medication Guide to each patient.

Rx only 90 Tablets

Each film-coated tablet contains:
Pantoprazole 20 mg
(equivalent to 22.55 mg of pantoprazole
sodium, USP)

Meets USP Dissolution Test 3.

Usual Dosage: See accompanying
prescribing information.

Keep this and all medication out of the
reach of children.

Store at 20° to 25°C (68° to 77°F). [See
USP Controlled Room Temperature.]

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in India

RMX6688MM7

Mylan.com

Dispense in a tight, light-resistant
container as defined in the USPusing a child-resistant closure.

Keep container tightly closed.

Code No.: MH/DRUGS/25/NKD/89

PRINCIPAL DISPLAY PANEL – 40 mg

NDC 0378-6689-77

Pantoprazole Sodium
Delayed-Release
Tablets, USP
40 mg

Swallow tablets whole. Do NOT split,
chew, or crush tablets.

PHARMACIST: Dispense the accompanying
Medication Guide to each patient.

Rx only 90 Tablets

Each film-coated tablet contains:
Pantoprazole 40 mg
(equivalent to 45.10 mg of pantoprazole
sodium, USP)

Meets USP Dissolution Test 3.

Usual Dosage: See accompanying
prescribing information.

Keep this and all medication out of the
reach of children.

Store at 20° to 25°C (68° to 77°F). [See
USP Controlled Room Temperature.]

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in India

RMX6689MM7

Mylan.com

Dispense in a tight, light-resistant
container as defined in the USPusing a child-resistant closure.

Keep container tightly closed.

Code No.: MH/DRUGS/25/NKD/89

PANTOPRAZOLE SODIUM pantoprazole sodium tablet, delayed release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-6688 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PANTOPRAZOLE SODIUM (PANTOPRAZOLE) PANTOPRAZOLE 20 mg

Inactive Ingredients Ingredient Name Strength FERROSOFERRIC OXIDE CALCIUM STEARATE CROSPOVIDONE (35 .MU.M) HYPROMELLOSE, UNSPECIFIED MANNITOL METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A POVIDONE K90 POVIDONE K25 PROPYLENE GLYCOL SODIUM CARBONATE SHELLAC TITANIUM DIOXIDE TRIETHYL CITRATE FERRIC OXIDE YELLOW

Product Characteristics Color YELLOW (dark yellow) Score no score Shape OVAL Size 8mm Flavor Imprint Code M;P8 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0378-6688-77 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC None 2 NDC:0378-6688-99 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090970 01/19/2011

PANTOPRAZOLE SODIUM pantoprazole sodium tablet, delayed release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-6689 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PANTOPRAZOLE SODIUM (PANTOPRAZOLE) PANTOPRAZOLE 40 mg

Inactive Ingredients Ingredient Name Strength FERROSOFERRIC OXIDE CALCIUM STEARATE CROSPOVIDONE (35 .MU.M) HYPROMELLOSE, UNSPECIFIED MANNITOL METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A POVIDONE K90 POVIDONE K25 PROPYLENE GLYCOL SODIUM CARBONATE SHELLAC TITANIUM DIOXIDE TRIETHYL CITRATE FERRIC OXIDE YELLOW

Product Characteristics Color YELLOW (dark yellow) Score no score Shape OVAL Size 11mm Flavor Imprint Code M;P9 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0378-6689-77 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC None 2 NDC:0378-6689-10 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC None 3 NDC:0378-6689-99 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090970 01/19/2011

Labeler — Mylan Pharmaceuticals Inc. (059295980)

Revised: 03/2023 Mylan Pharmaceuticals Inc.