NDC 0023-5874

Byvalson

Nebivolol Hydrochloride And Valsartan

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

Product ID0023-5874_6964c0d8-8223-4992-b42c-43d3de03080e
NDC0023-5874
Product TypeHuman Prescription Drug
Proprietary NameByvalson
Generic NameNebivolol Hydrochloride And Valsartan
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-06-03
Marketing CategoryNDA / NDA
Application NumberNDA206302
Labeler NameAllergan, Inc.
Substance NameNEBIVOLOL HYDROCHLORIDE; VALSARTAN
Active Ingredient Strength5 mg/1; mg/1
Pharm ClassesAdrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0023-5874-90

90 TABLET, FILM COATED in 1 BOTTLE (0023-5874-90)
Marketing Start Date2016-06-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0023-5874-32 [00023587432]

Byvalson TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA206302
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-06-03
Marketing End Date2019-05-31

NDC 0023-5874-07 [00023587407]

Byvalson TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA206302
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-06-03
Marketing End Date2019-05-31

NDC 0023-5874-90 [00023587490]

Byvalson TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA206302
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-06-03
Marketing End Date2019-05-31

NDC 0023-5874-84 [00023587484]

Byvalson TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA206302
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-06-03
Marketing End Date2019-05-31

NDC 0023-5874-31 [00023587431]

Byvalson TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA206302
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-06-03
Marketing End Date2019-05-31

NDC 0023-5874-30 [00023587430]

Byvalson TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA206302
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-06-03
Marketing End Date2019-05-31

Drug Details

Active Ingredients

IngredientStrength
NEBIVOLOL HYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:b4ad6a5b-e69d-4b39-9fe3-58569a964978
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1798281
  • 1798287
  • UPC Code
  • 0300235874309
  • Pharmacological Class

    • Adrenergic beta-Antagonists [MoA]
    • beta-Adrenergic Blocker [EPC]
    • Angiotensin 2 Receptor Antagonists [MoA]
    • Angiotensin 2 Receptor Blocker [EPC]

    Trademark Results [Byvalson]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    BYVALSON
    BYVALSON
    86101968 5073605 Live/Registered
    ALLERGAN SALES, LLC
    2013-10-25

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