NDC 70710-1069

VARDENAFIL

Vardenafil

VARDENAFIL is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Vardenafil Hydrochloride Trihydrate.

Product ID70710-1069_11dc6238-f3ca-42d3-9146-d7e01588a3cb
NDC70710-1069
Product TypeHuman Prescription Drug
Proprietary NameVARDENAFIL
Generic NameVardenafil
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-11-01
Marketing CategoryANDA / ANDA
Application NumberANDA208960
Labeler NameZydus Pharmaceuticals (USA) Inc.
Substance NameVARDENAFIL HYDROCHLORIDE TRIHYDRATE
Active Ingredient Strength5 mg/1
Pharm ClassesPhosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70710-1069-1

100 TABLET, FILM COATED in 1 BOTTLE (70710-1069-1)
Marketing Start Date2018-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70710-1069-1 [70710106901]

VARDENAFIL TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA208960
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-01

NDC 70710-1069-3 [70710106903]

VARDENAFIL TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA208960
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-11-01

NDC 70710-1069-9 [70710106909]

VARDENAFIL TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA208960
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-01

Drug Details

Active Ingredients

IngredientStrength
VARDENAFIL HYDROCHLORIDE TRIHYDRATE5 mg/1

OpenFDA Data

SPL SET ID:5876e062-e604-42a7-99c3-5da30b8dac06
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 349479
  • 349478
  • 402273
  • 349480
    • UPC Code
  • 0370770107156

    • Pharmacological Class

    • Phosphodiesterase 5 Inhibitor [EPC]
    • Phosphodiesterase 5 Inhibitors [MoA]

    NDC Crossover Matching brand name "VARDENAFIL" or generic name "Vardenafil"

    NDCBrand NameGeneric Name
    33342-203VardenafilVardenafil
    46708-235VardenafilVardenafil
    51407-174VARDENAFILVARDENAFIL
    62332-235VardenafilVardenafil
    70710-1068VARDENAFILVARDENAFIL
    70710-1069VARDENAFILVARDENAFIL
    70710-1070VARDENAFILVARDENAFIL
    70710-1071VARDENAFILVARDENAFIL
    70771-1047VARDENAFILVARDENAFIL
    70771-1048VARDENAFILVARDENAFIL
    70771-1049VARDENAFILVARDENAFIL
    70771-1050VARDENAFILVARDENAFIL
    71610-477VARDENAFILVARDENAFIL
    71610-643VARDENAFILVARDENAFIL
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