NDC 0002-4462

Cialis

Tadalafil

Cialis is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Eli Lilly And Company. The primary component is Tadalafil.

Product ID0002-4462_05dbd8b6-1b9d-436a-a67c-8a16713f753f
NDC0002-4462
Product TypeHuman Prescription Drug
Proprietary NameCialis
Generic NameTadalafil
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2003-11-26
Marketing CategoryNDA / NDA
Application NumberNDA021368
Labeler NameEli Lilly and Company
Substance NameTADALAFIL
Active Ingredient Strength5 mg/1
Pharm ClassesPhosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0002-4462-30

30 TABLET, FILM COATED in 1 BOTTLE (0002-4462-30)
Marketing Start Date2003-11-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0002-4462-61 [00002446261]

Cialis TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021368
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-01-07
Marketing End Date2019-05-31

NDC 0002-4462-01 [00002446201]

Cialis TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021368
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-06-23
Marketing End Date2014-03-24

NDC 0002-4462-34 [00002446234]

Cialis TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021368
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-01-07

NDC 0002-4462-30 [00002446230]

Cialis TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021368
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-11-26

NDC 0002-4462-79 [00002446279]

Cialis TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021368
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-06-23

NDC 0002-4462-10 [00002446210]

Cialis TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021368
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2003-11-26
Marketing End Date2012-06-30

Drug Details

Active Ingredients

IngredientStrength
TADALAFIL5 mg/1

OpenFDA Data

SPL SET ID:bcd8f8ab-81a2-4891-83db-24a0b0e25895
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 402019
  • 762660
  • 484814
  • 403957
  • 757707
  • 404711
  • 402097
  • 402096
  • UPC Code
  • 0300024463301
  • 0300024462304
  • 0300024464308
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0002-4462CialisTadalafil
    0002-4463CialisTadalafil
    0002-4464CialisTadalafil
    0002-4465CialisTadalafil
    21695-028CialisCialis
    21695-029CialisCialis
    43353-857CialisCialis
    43063-236CialisCialis
    43353-044CialisCialis
    50436-4464CialisCialis
    50436-4465CialisCialis
    50436-4463CialisCialis
    50436-4462CialisCialis
    55154-1830CialisCialis
    55154-1832CialisCialis
    63629-4601CialisCialis
    63629-6367CialisCialis
    63629-7145CialisCialis
    63629-6769CialisCialis
    66336-566CialisCialis
    0093-3334ALYQTadalafil
    0093-3016TadalafilTadalafil
    0093-3017TadalafilTadalafil
    0093-3018TadalafilTadalafil
    0093-3019TadalafilTadalafil

    Trademark Results [Cialis]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CIALIS
    CIALIS
    78971555 not registered Dead/Abandoned
    ELI LILLY AND COMPANY
    2006-09-11
    CIALIS
    CIALIS
    76536972 not registered Dead/Abandoned
    Y.Z.Y. Inc
    2003-08-01
    CIALIS
    CIALIS
    75731188 2724589 Live/Registered
    ELI LILLY AND COMPANY
    1999-06-17

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.