NDC 43353-323

Levitra

Vardenafil Hydrochloride

Levitra is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Inc.. The primary component is Vardenafil Hydrochloride.

Product ID43353-323_741bda18-742a-4192-b37c-41680ca38343
NDC43353-323
Product TypeHuman Prescription Drug
Proprietary NameLevitra
Generic NameVardenafil Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2008-05-15
Marketing CategoryNDA / NDA
Application NumberNDA021400
Labeler NameAPHENA PHARMA SOLUTIONS - TENNESSEE, INC.
Substance NameVARDENAFIL HYDROCHLORIDE
Active Ingredient Strength5 mg/1
Pharm ClassesPhosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 43353-323-06

6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-323-06)
Marketing Start Date2008-05-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43353-323-06 [43353032306]

Levitra TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021400
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-05-15
Inactivation Date2019-11-13

NDC 43353-323-02 [43353032302]

Levitra TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021400
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-05-15
Inactivation Date2019-11-13

Drug Details

Active Ingredients

IngredientStrength
VARDENAFIL HYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:be38b325-3a6f-4569-9ae0-a03feff8535d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 349478
  • 404637

    • 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
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