Bisoprolol Fumarate and Hydrochlorothiazide (Page 8 of 8)

HOW SUPPLIED

Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP are supplied as

2.5 mg/6.25 mg

Light yellow coloured, biconvex, round, film coated tablets debossed with UL on one side and | on other side.

Bottles of 30: NDC 29300-187-13

Bottles of 100: NDC 29300-187-01

Bottles of 500: NDC 29300-187-05

Bottles of 1000: NDC 29300-187-10

5 mg/6.25 mg

Salmon pink coloured, biconvex, round, film coated tablets debossed with UL on one side and | | on other side.

Bottles of 30: NDC 29300-188-13

Bottles of 100: NDC 29300-188-01

Bottles of 500: NDC 29300-188-05

Bottles of 1000: NDC 29300-188-10

10 mg/6.25 mg

White coloured, biconvex, round, film coated tablets debossed with UL on one side and | | | on other side.

Bottles of 30: NDC 29300-189-13

Bottles of 100: NDC 29300-189-01

Bottles of 500: NDC 29300-189-05

Bottles of 1000: NDC 29300-189-10

Store at 20 0 to 25 0 C (68 0 to 77 0 F) [see USP Controlled Room Temperature].

Dispense in a tight container.

Please address medical inquiries to Unichem’s toll free # 1-866-562-4616.

Manufactured by:

UNICHEM LABORATORIES LTD.

Pilerne Ind. Estate, Pilerne, Bardez,

Goa 403511, India

Manufactured for:

Company Logo
(click image for full-size original)

East Brunswick, NJ 08816

08-R-09/2019

13011522

DRUG: bisoprolol fumarate and hydrochlorothiazide

GENERIC: bisoprolol fumarate and hydrochlorothiazide

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-1947-0

COLOR: white

SHAPE: ROUND

SCORE: No score

SIZE: 8 mm

IMPRINT: UL;lll

PACKAGING: 90 in 1 BOTTLE, PLASTIC

ACTIVE INGREDIENT(S):

  • BISOPROLOL FUMARATE 10mg in 1
  • HYDROCHLOROTHIAZIDE 6.25mg in 1

INACTIVE INGREDIENT(S):

  • ANHYDROUS DIBASIC CALCIUM PHOSPHATE
  • SILICON DIOXIDE
  • POLYETHYLENE GLYCOL 6000
  • STARCH, CORN
  • MAGNESIUM STEARATE
  • CELLULOSE, MICROCRYSTALLINE
  • COPOVIDONE
  • HYPROMELLOSE 2910 (5 MPA.S)
  • TITANIUM DIOXIDE
Remedy_Label
(click image for full-size original)
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE bisoprolol fumarate and hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-1947(NDC:29300-189)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 6.25 mg
BISOPROLOL FUMARATE (BISOPROLOL) BISOPROLOL FUMARATE 10 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
CELLULOSE, MICROCRYSTALLINE
COPOVIDONE
HYPROMELLOSE 2910 (5 MPA.S)
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 6000
SILICON DIOXIDE
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape ROUND Size 8mm
Flavor Imprint Code UL;lll
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70518-1947-0 90 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079106 03/12/2019
Labeler — REMEDYREPACK INC. (829572556)

Revised: 11/2019 REMEDYREPACK INC.

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