NDC 0173-0822

Staxyn

Vardenafil Hydrochloride

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

Product ID0173-0822_1a2c1fa7-6a5f-47e8-a487-1aa4a0e179b5
NDC0173-0822
Product TypeHuman Prescription Drug
Proprietary NameStaxyn
Generic NameVardenafil Hydrochloride
Dosage FormTablet, Orally Disintegrating
Route of AdministrationORAL
Marketing Start Date2011-04-21
Marketing CategoryNDA / NDA
Application NumberNDA200179
Labeler NameGlaxoSmithKline LLC
Substance NameVARDENAFIL HYDROCHLORIDE
Active Ingredient Strength12 mg/1
Pharm ClassesPhosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0173-0822-04

1 BLISTER PACK in 1 BOX (0173-0822-04) > 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Marketing Start Date2011-04-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0173-0822-04 [00173082204]

Staxyn TABLET, ORALLY DISINTEGRATING
Marketing CategoryNDA
Application NumberNDA200179
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-04-21

NDC 0173-0822-61 [00173082261]

Staxyn TABLET, ORALLY DISINTEGRATING
Marketing CategoryNDA
Application NumberNDA200179
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-04-21
Marketing End Date2020-02-28

NDC 0173-0822-14 [00173082214]

Staxyn TABLET, ORALLY DISINTEGRATING
Marketing CategoryNDA
Application NumberNDA200179
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-04-21
Marketing End Date2019-01-24

Drug Details

Active Ingredients

IngredientStrength
VARDENAFIL HYDROCHLORIDE11.85 mg/1

OpenFDA Data

SPL SET ID:0e5139d8-bf61-4f21-a36b-81b96b9b07d1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 996179
  • 996183
  • UPC Code
  • 0301730822048
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0173-0822Staxynvardenafil hydrochloride
    0173-0829Levitravardenafil hydrochloride
    0173-0830Levitravardenafil hydrochloride
    0173-0831Levitravardenafil 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 [Staxyn]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    STAXYN
    STAXYN
    77600029 4035352 Live/Registered
    BAYER AKTIENGESELLSCHAFT
    2008-10-24

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