NDC 15955-373

BISOPROLOL FUMARATE

Bisoprolol Fumarate

BISOPROLOL FUMARATE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Orit Laboratories Llc. The primary component is Bisoprolol Fumarate.

Product ID15955-373_230b6ffb-0586-4e80-962c-80058c1a14bd
NDC15955-373
Product TypeHuman Prescription Drug
Proprietary NameBISOPROLOL FUMARATE
Generic NameBisoprolol Fumarate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-09-11
Marketing CategoryANDA / ANDA
Application NumberANDA204891
Labeler NameORIT LABORATORIES LLC
Substance NameBISOPROLOL FUMARATE
Active Ingredient Strength5 mg/1
Pharm ClassesAdrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 15955-373-30

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (15955-373-30)
Marketing Start Date2019-09-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 15955-373-30 [15955037330]

BISOPROLOL FUMARATE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204891
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-09-11

NDC 15955-373-50 [15955037350]

BISOPROLOL FUMARATE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204891
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-09-11

Drug Details

Active Ingredients

IngredientStrength
BISOPROLOL FUMARATE5 mg/1

OpenFDA Data

SPL SET ID:230b6ffb-0586-4e80-962c-80058c1a14bd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 854905
  • 854901
  • UPC Code
  • 0315955374305
  • 0315955373308
  • Pharmacological Class

    • Adrenergic beta-Antagonists [MoA]
    • beta-Adrenergic Blocker [EPC]
    • Adrenergic beta-Antagonists [MoA]
    • beta-Adrenergic Blocker [EPC]

    NDC Crossover Matching brand name "BISOPROLOL FUMARATE" or generic name "Bisoprolol Fumarate"

    NDCBrand NameGeneric Name
    0093-5270Bisoprolol FumarateBisoprolol Fumarate
    0093-5271Bisoprolol FumarateBisoprolol Fumarate
    0185-0771bisoprolol fumaratebisoprolol fumarate
    0185-0774bisoprolol fumaratebisoprolol fumarate
    0378-0523Bisoprolol Fumaratebisoprolol fumarate
    0378-0524Bisoprolol Fumaratebisoprolol fumarate
    15955-373BISOPROLOL FUMARATEBISOPROLOL FUMARATE
    15955-374BISOPROLOL FUMARATEBISOPROLOL FUMARATE
    16714-529Bisoprolol FumarateBisoprolol Fumarate
    16714-530Bisoprolol FumarateBisoprolol Fumarate
    21695-667Bisoprolol FumarateBisoprolol fumarate
    21695-670Bisoprolol FumarateBisoprolol fumarate
    29300-126Bisoprolol FumarateBisoprolol fumarate
    29300-127Bisoprolol FumarateBisoprolol fumarate
    50268-127Bisoprolol FumarateBisoprolol Fumarate
    51407-645Bisoprolol FumarateBisoprolol Fumarate
    51407-646Bisoprolol FumarateBisoprolol Fumarate
    57237-132Bisoprolol FumarateBisoprolol Fumarate
    57237-133Bisoprolol FumarateBisoprolol Fumarate
    60687-679Bisoprolol FumarateBisoprolol fumarate
    61919-787BISOPROLOL FUMARATEBISOPROLOL FUMARATE
    62332-603BISOPROLOL FUMARATEBISOPROLOL FUMARATE
    62332-604BISOPROLOL FUMARATEBISOPROLOL FUMARATE
    63187-871Bisoprolol FumarateBisoprolol fumarate
    63629-5173Bisoprolol FumarateBisoprolol fumarate
    65862-086Bisoprolol FumarateBisoprolol Fumarate
    68071-1582Bisoprolol FumarateBisoprolol Fumarate
    68084-487bisoprolol fumaratebisoprolol fumarate
    68151-4504Bisoprolol FumarateBisoprolol Fumarate
    68788-6775Bisoprolol FumarateBisoprolol Fumarate
    65862-087Bisoprolol FumarateBisoprolol Fumarate
    52817-270BisoprololBisoprolol fumarate
    52817-271BisoprololBisoprolol fumarate
    63629-6907BisoprololBisoprolol fumarate

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