NDC 0378-0503

Bisoprolol Fumarate and Hydrochlorothiazide

Bisoprolol Fumarate And Hydrochlorothiazide

Bisoprolol Fumarate and Hydrochlorothiazide is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Bisoprolol Fumarate; Hydrochlorothiazide.

Product ID0378-0503_39927d43-a926-48bd-aaeb-eba414867662
NDC0378-0503
Product TypeHuman Prescription Drug
Proprietary NameBisoprolol Fumarate and Hydrochlorothiazide
Generic NameBisoprolol Fumarate And Hydrochlorothiazide
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2021-02-22
Marketing CategoryANDA / ANDA
Application NumberANDA075768
Labeler NameMylan Pharmaceuticals Inc.
Substance NameBISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
Active Ingredient Strength5 mg/1; mg/1
Pharm ClassesAdrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0378-0503-01

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0503-01)
Marketing Start Date2021-02-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-0503-05 [00378050305]

Bisoprolol Fumarate and Hydrochlorothiazide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075768
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2000-09-25
Marketing End Date2017-07-07

NDC 0378-0503-10 [00378050310]

Bisoprolol Fumarate and Hydrochlorothiazide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075768
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2000-09-25
Marketing End Date2019-08-31

NDC 0378-0503-01 [00378050301]

Bisoprolol Fumarate and Hydrochlorothiazide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075768
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2000-09-25
Marketing End Date2019-08-31

Drug Details

Active Ingredients

IngredientStrength
BISOPROLOL FUMARATE5 mg/1

OpenFDA Data

SPL SET ID:d4243a76-516c-417e-80ba-444a21ecc688
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 854916
  • 854919
  • 854908

    • Pharmacological Class

    • Adrenergic beta-Antagonists [MoA]
    • beta-Adrenergic Blocker [EPC]
    • Increased Diuresis [PE]
    • Thiazide Diuretic [EPC]
    • Thiazides [CS]

    NDC Crossover Matching brand name "Bisoprolol Fumarate and Hydrochlorothiazide" or generic name "Bisoprolol Fumarate And Hydrochlorothiazide"

    NDCBrand NameGeneric Name
    0093-3241bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazide
    0093-3242bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazide
    0093-3243bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazide
    0185-0707Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and Hydrochlorothiazide
    0378-0501Bisoprolol Fumarate and Hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazide
    0378-0503Bisoprolol Fumarate and Hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazide
    0378-0505Bisoprolol Fumarate and Hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazide
    10135-740Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and Hydrochlorothiazide
    10135-741Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and Hydrochlorothiazide
    10135-742Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and Hydrochlorothiazide
    10544-173bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazide
    10544-174bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazide
    10544-563bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazide
    21695-808Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and Hydrochlorothiazide
    21695-809Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and Hydrochlorothiazide
    29300-187bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazide
    68071-2131bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazide
    68788-6880bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazide
    70518-1947bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazide
    71335-0240bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazide
    71335-0595bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazide
    29300-188bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazide
    29300-189bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazide
    33261-918bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazide
    43063-134Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and Hydrochlorothiazide
    50090-0789bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazide
    50090-0799bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazide
    50090-0796bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazide
    63629-4072Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and Hydrochlorothiazide
    63629-7150bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazide
    67296-1268bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazide
    67296-0947bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazide
    71335-1161bisoprolol fumarate and hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazide
    42799-922Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and Hydrochlorothiazide
    42799-921Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and Hydrochlorothiazide
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