Metoprolol Tartrate and Hydrochlorothiazide (Page 6 of 6)

HOW SUPPLIED

Metoprolol Tartrate and Hydrochlorothiazide Tablets, USP are available containing 50 mg or 100 mg of metoprolol tartrate, USP and 25 mg or 50 mg of hydrochlorothiazide, USP providing for the following available combinations: 50 mg/25 mg, 100 mg/25 mg or 100 mg/50 mg.

The 50 mg/25 mg tablets are peach, round, scored tablets debossed with M above the score and 424 below the score on one side of the tablet and blank on the other side. They are available as follows:

NDC 0378-0424-01
bottles of 100 tablets

The 100 mg/25 mg tablets are peach, oval, scored tablets debossed with M to the left of the score and 434 to the right of the score on one side of the tablet and blank on the other side. They are available as follows:

NDC 0378-0434-01
bottles of 100 tablets

The 100 mg/50 mg tablets are peach, capsule-shaped, scored tablets debossed with M to the left of the score and 445 to the right of the score on one side of the tablet and blank on the other side. They are available as follows:

NDC 0378-0445-01
bottles of 100 tablets

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

Protect from moisture.

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

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

Manufactured by:
Mylan Laboratories Limited

Hyderabad — 500 096, India

Revised: 9/2020
MXA:MPHCTZ:R2

75077678

PRINCIPAL DISPLAY PANEL — 50 mg/25 mg

NDC 0378-0424-01

Metoprolol
Tartrate and
Hydrochlorothiazide
Tablets, USP
50 mg/25 mg

Rx only 100 Tablets

Each tablet contains:
Metoprolol tartrate, USP 50 mg
Hydrochlorothiazide, USP 25 mg

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.]

Protect from moisture.

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

Made in India

Mylan.com

RMXA0424A1

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

Keep container tightly closed.

Code No.: MH/DRUGS/AD/089

Metoprolol Tartrate and Hydrochlorothiazide Tablets, USP 50 mg/25 mg Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 100 mg/25 mg

NDC 0378-0434-01

Metoprolol
Tartrate and
Hydrochlorothiazide
Tablets, USP
100 mg/25 mg

Rx only 100 Tablets

Each tablet contains:
Metoprolol tartrate, USP 100 mg
Hydrochlorothiazide, USP 25 mg

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.]

Protect from moisture.

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

Made in India

Mylan.com

RMXA0434A1

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

Keep container tightly closed.

Code No.: MH/DRUGS/AD/089

Metoprolol Tartrate and Hydrochlorothiazide Tablets, USP 100 mg/25 mg Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 100 mg/50 mg

NDC 0378-0445-01

Metoprolol
Tartrate and
Hydrochlorothiazide
Tablets, USP
100 mg/50 mg

Rx only 100 Tablets

Each tablet contains:
Metoprolol tartrate, USP 100 mg
Hydrochlorothiazide, USP 50 mg

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.]

Protect from moisture.

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

Made in India

Mylan.com

RMXA0445A1

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

Keep container tightly closed.

Code No.: MH/DRUGS/AD/089

Metoprolol Tartrate and Hydrochlorothiazide Tablets, USP 100 mg/50 mg Bottle Label
(click image for full-size original)
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE metoprolol tartrate and hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-0424
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METOPROLOL TARTRATE (METOPROLOL) METOPROLOL TARTRATE 50 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
FD&C YELLOW NO. 6
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE, UNSPECIFIED
STARCH, CORN
SODIUM LAURYL SULFATE
Product Characteristics
Color ORANGE (peach) Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code M;424
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-0424-01 100 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076792 08/20/2004
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE metoprolol tartrate and hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-0434
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METOPROLOL TARTRATE (METOPROLOL) METOPROLOL TARTRATE 100 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
FD&C YELLOW NO. 6
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE, UNSPECIFIED
STARCH, CORN
SODIUM LAURYL SULFATE
Product Characteristics
Color ORANGE (peach) Score 2 pieces
Shape OVAL Size 15mm
Flavor Imprint Code M;434
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-0434-01 100 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076792 08/20/2004
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE metoprolol tartrate and hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-0445
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METOPROLOL TARTRATE (METOPROLOL) METOPROLOL TARTRATE 100 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
FD&C YELLOW NO. 6
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE, UNSPECIFIED
STARCH, CORN
SODIUM LAURYL SULFATE
Product Characteristics
Color ORANGE (peach) Score 2 pieces
Shape OVAL (capsule-shaped) Size 18mm
Flavor Imprint Code M;445
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-0445-01 100 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076792 08/20/2004
Labeler — Mylan Pharmaceuticals Inc. (059295980)

Revised: 09/2020 Mylan Pharmaceuticals Inc.

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