NDC 68151-5135

Bystolic

Nebivolol Hydrochloride

Bystolic is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Carilion Materials Management. The primary component is Nebivolol Hydrochloride.

Product ID68151-5135_ca39c719-336a-437e-b7d2-98bb32ecd619
NDC68151-5135
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 NameCarilion Materials Management
Substance NameNEBIVOLOL HYDROCHLORIDE
Active Ingredient Strength10 mg/1
Pharm ClassesAdrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 68151-5135-7

1 TABLET in 1 CUP (68151-5135-7)
Marketing Start Date2008-01-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68151-5135-7 [68151513507]

Bystolic TABLET
Marketing CategoryNDA
Application NumberNDA021742
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-01-22
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
NEBIVOLOL HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:07ed02ff-523f-437e-bddc-5c41a4bb0062
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 751616
  • 751612

    • 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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.