NDC 0456-1402

Bystolic

Nebivolol Hydrochloride

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

Product ID0456-1402_3f38e87f-c08a-4c22-8f31-b7d41f58b967
NDC0456-1402
Product TypeHuman Prescription Drug
Proprietary NameBystolic
Generic NameNebivolol Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2008-01-22
Marketing CategoryNDA / NDA
Application NumberNDA021742
Labeler NameAllergan, Inc.
Substance NameNEBIVOLOL HYDROCHLORIDE
Active Ingredient Strength3 mg/1
Pharm ClassesAdrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0456-1402-01

100 TABLET in 1 BOTTLE (0456-1402-01)
Marketing Start Date2008-01-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0456-1402-01 [00456140201]

Bystolic TABLET
Marketing CategoryNDA
Application NumberNDA021742
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-01-22

NDC 0456-1402-63 [00456140263]

Bystolic TABLET
Marketing CategoryNDA
Application NumberNDA021742
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-01-22

NDC 0456-1402-30 [00456140230]

Bystolic TABLET
Marketing CategoryNDA
Application NumberNDA021742
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-01-22

NDC 0456-1402-90 [00456140290]

Bystolic TABLET
Marketing CategoryNDA
Application NumberNDA021742
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-01-22

Drug Details

Active Ingredients

IngredientStrength
NEBIVOLOL HYDROCHLORIDE2.5 mg/1

OpenFDA Data

SPL SET ID:8b8ad213-1dc8-454e-a524-075685c0e1a8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 827075
  • 827073
  • 387013
  • 751620
  • 751623
  • 751618
  • 751616
  • 751612
    • UPC Code
  • 0304561420902
  • 0304561405305
  • 0304561410309
  • 0304561402304
  • 0304561405909
  • 0304561410903
  • 0304561420308

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0456-1402Bystolicnebivolol hydrochloride
    0456-1405Bystolicnebivolol hydrochloride
    0456-1410Bystolicnebivolol hydrochloride
    0456-1420Bystolicnebivolol hydrochloride
    50090-1127Bystolicnebivolol hydrochloride
    50090-1307Bystolicnebivolol hydrochloride
    50090-3326Bystolicnebivolol hydrochloride
    55154-4621Bystolicnebivolol hydrochloride
    55154-4622Bystolicnebivolol hydrochloride
    55154-4623Bystolicnebivolol hydrochloride
    68151-5135BystolicBystolic
    29300-375Nebivolol HydrochlorideNebivolol Hydrochloride
    29300-376Nebivolol HydrochlorideNebivolol Hydrochloride
    29300-377Nebivolol HydrochlorideNebivolol Hydrochloride
    29300-378Nebivolol HydrochlorideNebivolol Hydrochloride

    Trademark Results [Bystolic]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    BYSTOLIC
    BYSTOLIC
    78598232 3412780 Live/Registered
    ALLERGAN SALES, LLC
    2005-03-30
    BYSTOLIC
    BYSTOLIC
    78081886 not registered Dead/Abandoned
    Forest Laboratories, Inc.
    2001-08-30
    BYSTOLIC
    BYSTOLIC
    77363854 3609793 Live/Registered
    ALLERGAN SALES, LLC
    2008-01-03
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.