NDC 43353-070

ADCIRCA

Tadalafil

ADCIRCA is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Tadalafil.

Product ID43353-070_710cf772-574e-4ecd-a8aa-34190c719115
NDC43353-070
Product TypeHuman Prescription Drug
Proprietary NameADCIRCA
Generic NameTadalafil
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-05-22
Marketing CategoryNDA / NDA
Application NumberNDA022332
Labeler NameAphena Pharma Solutions - Tennessee, LLC
Substance NameTADALAFIL
Active Ingredient Strength20 mg/1
Pharm ClassesPhosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 43353-070-12

12 TABLET in 1 BOTTLE (43353-070-12)
Marketing Start Date2017-06-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43353-070-12 [43353007012]

ADCIRCA TABLET
Marketing CategoryNDA
Application NumberNDA022332
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-06-22

Drug Details

Active Ingredients

IngredientStrength
TADALAFIL20 mg/1

OpenFDA Data

SPL SET ID:3ca3928a-6466-4290-a228-461fa8a91735
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 849866
  • 402019
  • Pharmacological Class

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

    NDC Crossover Matching brand name "ADCIRCA" or generic name "Tadalafil"

    NDCBrand NameGeneric Name
    43353-070ADCIRCAADCIRCA
    66302-467ADCIRCAADCIRCA
    0093-3334ALYQTadalafil
    0002-4462CialisTadalafil
    0002-4463CialisTadalafil
    0002-4464CialisTadalafil
    0002-4465CialisTadalafil
    0093-3016TadalafilTadalafil
    0093-3017TadalafilTadalafil
    0093-3018TadalafilTadalafil
    0093-3019TadalafilTadalafil

    Trademark Results [ADCIRCA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ADCIRCA
    ADCIRCA
    78737811 not registered Dead/Abandoned
    ELI LILLY AND COMPANY
    2005-10-21
    ADCIRCA
    ADCIRCA
    77860178 3844162 Live/Registered
    Eli Lilly and Company
    2009-10-29
    ADCIRCA
    ADCIRCA
    77262532 3677077 Live/Registered
    Eli Lilly and Company
    2007-08-23

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