NDC 0527-2801

Vardenafil Hydrochloride

Vardenafil Hydrochloride

Vardenafil Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Lannett Company, Inc.. The primary component is Vardenafil Hydrochloride.

Product ID0527-2801_3d24176d-55f7-4009-a96a-caf72da1222e
NDC0527-2801
Product TypeHuman Prescription Drug
Proprietary NameVardenafil Hydrochloride
Generic NameVardenafil Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-11-01
Marketing CategoryANDA / ANDA
Application NumberANDA209057
Labeler NameLannett Company, Inc.
Substance NameVARDENAFIL HYDROCHLORIDE
Active Ingredient Strength5 mg/1
Pharm ClassesPhosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2024-12-31

Packaging

NDC 0527-2801-32

30 TABLET in 1 BOTTLE (0527-2801-32)
Marketing Start Date2018-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0527-2801-32 [00527280132]

Vardenafil Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA209057
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-11-01
Inactivation Date2020-01-31
Reactivation Date2020-04-17

Drug Details

Active Ingredients

IngredientStrength
VARDENAFIL HYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:2782efed-6198-47b9-81ac-3e255e2ab7f6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 349479
  • 349478
  • 402273
  • 349480

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0093-7652Vardenafil HydrochlorideVardenafil Hydrochloride
    0093-7653Vardenafil HydrochlorideVardenafil Hydrochloride
    0093-7654Vardenafil HydrochlorideVardenafil Hydrochloride
    0093-7655Vardenafil HydrochlorideVardenafil Hydrochloride
    0527-2800Vardenafil HydrochlorideVardenafil Hydrochloride
    0527-2801Vardenafil HydrochlorideVardenafil Hydrochloride
    0527-2802Vardenafil HydrochlorideVardenafil Hydrochloride
    0527-2803Vardenafil HydrochlorideVardenafil Hydrochloride
    69238-1152Vardenafil hydrochlorideVardenafil hydrochloride
    69238-1153Vardenafil hydrochlorideVardenafil hydrochloride
    69238-1151Vardenafil hydrochlorideVardenafil hydrochloride
    42291-847Vardenafil HydrochlorideVardenafil Hydrochloride
    42291-848Vardenafil HydrochlorideVardenafil Hydrochloride
    71610-310Vardenafil HydrochlorideVardenafil Hydrochloride
    33342-151Vardenafil HydrochlorideVardenafil Hydrochloride
    33342-152Vardenafil HydrochlorideVardenafil Hydrochloride
    33342-154Vardenafil HydrochlorideVardenafil Hydrochloride
    33342-153Vardenafil HydrochlorideVardenafil Hydrochloride
    62332-237VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDE
    46708-237VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDE
    46708-239VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDE
    62332-239VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDE
    0173-0829Levitravardenafil hydrochloride
    0173-0830Levitravardenafil hydrochloride
    0173-0831Levitravardenafil hydrochloride
    0173-0822Staxynvardenafil hydrochloride
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.