NDC 63629-4601

Cialis

Tadalafil

Cialis is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Tadalafil.

Product ID63629-4601_95941052-a9f9-4b0b-885c-efc4d114b6a9
NDC63629-4601
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 NameBryant Ranch Prepack
Substance NameTADALAFIL
Active Ingredient Strength5 mg/1
Pharm ClassesPhosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 63629-4601-1

1 TABLET, FILM COATED in 1 BOTTLE (63629-4601-1)
Marketing Start Date2015-09-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-4601-1 [63629460101]

Cialis TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021368
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-09-17
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
TADALAFIL5 mg/1

OpenFDA Data

SPL SET ID:bd516af6-f8c2-4b47-9958-af5ec176975d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 403957
  • 404711

    • 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
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