NDC 0173-0830

Levitra

Vardenafil Hydrochloride

Levitra is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Glaxosmithkline Llc. The primary component is Vardenafil Hydrochloride.

Product ID0173-0830_084e9ed5-726f-4bf4-8b51-34687f75cbed
NDC0173-0830
Product TypeHuman Prescription Drug
Proprietary NameLevitra
Generic NameVardenafil Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2003-08-25
Marketing End Date2021-12-31
Marketing CategoryNDA / NDA
Application NumberNDA021400
Labeler NameGlaxoSmithKline LLC
Substance NameVARDENAFIL HYDROCHLORIDE
Active Ingredient Strength10 mg/1
Pharm ClassesPhosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
NDC Exclude FlagN

Packaging

NDC 0173-0830-13

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0173-0830-13)
Marketing Start Date2017-08-25
Marketing End Date2021-12-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0173-0830-13 [00173083013]

Levitra TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021400
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-08-25

NDC 0173-0830-61 [00173083061]

Levitra TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021400
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2003-08-25

Drug Details

Active Ingredients

IngredientStrength
VARDENAFIL HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:a01def95-c0ef-43b9-bd9e-5565b2385ad3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 402273
  • 349480
  • 349479
  • 349478
  • 404637
  • 404636
  • 404639
  • 404638
    • UPC Code
  • 0301730828132
  • 0301730831132
  • 0301730829139
  • 0301730830135

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0173-0829Levitravardenafil hydrochloride
    0173-0830Levitravardenafil hydrochloride
    0173-0831Levitravardenafil hydrochloride
    43353-741LevitraLevitra
    43353-748LevitraLevitra
    43353-744LevitraLevitra
    43353-323LevitraLevitra
    55289-193LevitraLevitra
    63629-3372LevitraLevitra
    67544-507LevitraLevitra
    67544-512LevitraLevitra
    0173-0822Staxynvardenafil hydrochloride
    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

    Trademark Results [Levitra]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    LEVITRA
    LEVITRA
    78560108 3050814 Live/Registered
    Bayer Aktiengesellschaft
    2005-02-03
    LEVITRA
    LEVITRA
    75913260 2622847 Live/Registered
    Bayer Aktiengesellschaft
    2000-02-08
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.