NDC 50090-1127

Bystolic

Nebivolol Hydrochloride

Bystolic is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Nebivolol Hydro.

Product ID50090-1127_0bf927c4-913a-4375-8d29-cfefa27869a6
NDC50090-1127
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 NameA-S Medication Solutions
Substance NameNEBIVOLOL HYDRO
Active Ingredient Strength5 mg/1
Pharm ClassesAdrenergic beta
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50090-1127-0

30 TABLET in 1 BOTTLE (50090-1127-0)
Marketing Start Date2014-11-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50090-1127-0 [50090112700]

Bystolic TABLET
Marketing CategoryNDA
Application NumberNDA021742
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-11-28
Marketing End Date2019-04-11

NDC 50090-1127-1 [50090112701]

Bystolic TABLET
Marketing CategoryNDA
Application NumberNDA021742
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-19
Marketing End Date2019-04-11

Drug Details

Active Ingredients

IngredientStrength
NEBIVOLOL HYDROCHLORIDE5 mg/1

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.