Bisoprolol Fumarate and Hydrochlorothiazide (Page 8 of 8)

HOW SUPPLIED

Bisoprolol Fumarate and Hydrochlorothiazide — 2.5 mg/6.25 mg Tablets (bisoprolol fumarate 2.5 mg and hydrochlorothiazide 6.25 mg): Yellow, round, film-coated, unscored tablets. Debossed with stylized b within an engraved heart shape on one side and 47 on the other side, supplied as follows:

Bottle of 100 Tablets NDC 0093-3241-01

Bisoprolol Fumarate and Hydrochlorothiazide — 5 mg/6.25 mg Tablets (bisoprolol fumarate 5 mg and hydrochlorothiazide 6.25 mg): Pink, round, film-coated, unscored tablets. Debossed with stylized b within an engraved heart shape on one side and 50 on the other side, supplied as follows:

Bottle of 100 Tablets NDC 0093-3242-01

Bisoprolol Fumarate and Hydrochlorothiazide — 10 mg/6.25 mg Tablets (bisoprolol fumarate 10 mg and hydrochlorothiazide 6.25 mg): White, round, film-coated, unscored tablets. Debossed with stylized b within an engraved heart shape on one side and 40 on the other side, supplied as follows:

Bottle of 30 Tablets with child resistant closure NDC 0093-3243-56

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

Dispense in a tight container.

Distributed by:

TEVA PHARMACEUTICALS USA, INC.

Parsippany, NJ 07054

BFHCTZ-003

Rev. 03/2021

Package/Label Display Panel

2.5 6.25 label impage
(click image for full-size original)

NDC 0093-3241-01

Bisoprolol Fumarate and Hydrochlorothiazide Tablets 2.5 mg/6.25 mg

Rx only 100 Tablets

Teva

Each tablet contains:

Bisoprolol fumarate 2.5 mg

Hydrochlorothiazide 6.25 mg

DOSAGE: For complete directions for use, see accompanying package brochure.

Package/Label Display Panel

biso HCTZ 5 -- 6.25mg label image
(click image for full-size original)

NDC 0093-3242-01

Bisoprolol Fumarate and Hydrochlorothiazide Tablets 5 mg/6.25 mg

Rx only 100 Tablets

Teva

Each tablet contains:

Bisoprolol fumarate 5 mg

Hydrochlorothiazide 6.25 mg

DOSAGE: For complete directions for use, see accompanying package brochure.

Package/Label Display Panel

biso HCTZ 10 -- 6.25mg label image
(click image for full-size original)

NDC 0093-3243-56

Bisoprolol Fumarate and Hydrochlorothiazide Tablets 10 mg/6.25 mg

Rx only 100 Tablets

Teva

Each tablet contains:

Bisoprolol fumarate 10 mg

Hydrochlorothiazide 6.25 mg

DOSAGE: For complete directions for use, see accompanying package brochure.

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
bisoprolol fumarate and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-3241
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BISOPROLOL FUMARATE (BISOPROLOL) BISOPROLOL FUMARATE 2.5 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 6.25 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
TITANIUM DIOXIDE
CROSPOVIDONE (15 MPA.S AT 5%)
FERRIC OXIDE YELLOW
Product Characteristics
Color yellow Score no score
Shape ROUND Size 6mm
Flavor Imprint Code b;47
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-3241-01 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA020186 08/07/2019
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
bisoprolol fumarate and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-3242
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BISOPROLOL FUMARATE (BISOPROLOL) BISOPROLOL FUMARATE 5 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 6.25 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
SILICON DIOXIDE
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
Product Characteristics
Color pink Score no score
Shape ROUND Size 7mm
Flavor Imprint Code b;50
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-3242-01 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA020186 08/07/2019
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
bisoprolol fumarate and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-3243
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BISOPROLOL FUMARATE (BISOPROLOL) BISOPROLOL FUMARATE 10 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 6.25 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
TITANIUM DIOXIDE
SILICON DIOXIDE
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
Product Characteristics
Color white Score no score
Shape ROUND Size 7mm
Flavor Imprint Code b;40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-3243-56 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA020186 08/07/2019
Labeler — Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 04/2021 Teva Pharmaceuticals USA, Inc.

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