NDC 68382-896

Tadalafil

Tadalafil

Tadalafil is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals Usa Inc.. The primary component is Tadalafil.

Product ID68382-896_1c903b66-1d42-439a-957a-32e41a44ec70
NDC68382-896
Product TypeHuman Prescription Drug
Proprietary NameTadalafil
Generic NameTadalafil
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-03-27
Marketing CategoryANDA / ANDA
Application NumberANDA206693
Labeler NameZydus Pharmaceuticals USA Inc.
Substance NameTADALAFIL
Active Ingredient Strength3 mg/1
Pharm ClassesPhosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 68382-896-01

100 TABLET, FILM COATED in 1 BOTTLE (68382-896-01)
Marketing Start Date2019-03-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-896-16 [68382089616]

Tadalafil TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206693
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-27

NDC 68382-896-99 [68382089699]

Tadalafil TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206693
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-27

NDC 68382-896-05 [68382089605]

Tadalafil TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206693
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-27

NDC 68382-896-06 [68382089606]

Tadalafil TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206693
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-03-27

NDC 68382-896-01 [68382089601]

Tadalafil TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206693
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-27

NDC 68382-896-10 [68382089610]

Tadalafil TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206693
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-27

Drug Details

Active Ingredients

IngredientStrength
TADALAFIL2.5 mg/1

OpenFDA Data

SPL SET ID:cfe43ab8-8721-4db8-8810-f0072cf8f4d3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 484814
  • 402019
  • 757707
  • 403957
    • UPC Code
  • 0368382899064

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0093-3016TadalafilTadalafil
    0093-3017TadalafilTadalafil
    0093-3018TadalafilTadalafil
    0093-3019TadalafilTadalafil
    68180-914TadalafilTadalafil
    68382-896TadalafilTadalafil
    68382-898TadalafilTadalafil
    68382-897TadalafilTadalafil
    68382-899TadalafilTadalafil
    69097-376TadalafilTadalafil
    69097-375TadalafilTadalafil
    69097-373TadalafilTadalafil
    69097-526TadalafilTadalafil
    69097-374TadalafilTadalafil
    69238-1347TadalafilTadalafil
    69238-1346TadalafilTadalafil
    69238-1348TadalafilTadalafil
    69238-1349TadalafilTadalafil
    70771-1476TadalafilTadalafil
    70771-1477TadalafilTadalafil
    70771-1478TadalafilTadalafil
    70771-1475TadalafilTadalafil
    71610-214TadalafilTadalafil
    71610-213TadalafilTadalafil
    13668-568TADALAFILTADALAFIL
    13668-566TADALAFILTADALAFIL
    13668-567TADALAFILTADALAFIL
    13668-565TADALAFILTADALAFIL
    13668-581TADALAFILTADALAFIL
    16729-370TadalafilTadalafil
    16729-372TadalafilTadalafil
    16729-369TadalafilTadalafil
    27241-123TadalafilTadalafil
    27241-111TadalafilTadalafil
    27241-112TadalafilTadalafil
    29300-289tadalafiltadalafil
    29300-288tadalafiltadalafil
    27241-114TadalafilTadalafil
    27241-113TadalafilTadalafil
    31722-646TadalafilTadalafil
    29300-286tadalafiltadalafil
    31722-645TadalafilTadalafil
    29300-287tadalafiltadalafil
    31722-643TadalafilTadalafil
    31722-647TadalafilTadalafil
    31722-644TadalafilTadalafil
    35573-411TadalafilTadalafil
    35573-410TadalafilTadalafil
    35573-412TadalafilTadalafil
    35573-409TadalafilTadalafil
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