NDC 43975-248

Nebivolol

Nebivolol

Nebivolol is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Amerigen Pharmaceuticals Inc.. The primary component is Nebivolol Hydrochloride.

Product ID43975-248_02a8038f-f4bf-4f60-9888-b1233fa947d2
NDC43975-248
Product TypeHuman Prescription Drug
Proprietary NameNebivolol
Generic NameNebivolol
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2015-04-28
Marketing CategoryANDA / ANDA
Application NumberANDA203659
Labeler NameAmerigen Pharmaceuticals Inc.
Substance NameNEBIVOLOL HYDROCHLORIDE
Active Ingredient Strength3 mg/1
Pharm ClassesAdrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 43975-248-03

30 TABLET in 1 BOTTLE (43975-248-03)
Marketing Start Date2015-04-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43975-248-10 [43975024810]

Nebivolol TABLET
Marketing CategoryANDA
Application NumberANDA203659
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-04-28
Inactivation Date2020-01-31

NDC 43975-248-03 [43975024803]

Nebivolol TABLET
Marketing CategoryANDA
Application NumberANDA203659
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-04-28
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
NEBIVOLOL HYDROCHLORIDE2.5 mg/1

OpenFDA Data

SPL SET ID:8f98d499-f68f-4148-8ec3-8c66ef184a83
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 387013
  • 751618
  • 751612
  • 827073
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Nebivolol" or generic name "Nebivolol"

    NDCBrand NameGeneric Name
    0904-7189nebivololnebivolol
    0904-7190nebivololnebivolol
    0904-7225nebivololnebivolol
    0904-7226nebivololnebivolol
    13668-353nebivololnebivolol
    13668-354nebivololnebivolol
    13668-355nebivololnebivolol
    13668-356nebivololnebivolol
    43975-248NebivololNebivolol
    43975-250NebivololNebivolol
    43975-249NebivololNebivolol
    43975-251NebivololNebivolol

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.