NDC 13668-567

TADALAFIL

Tadalafil

TADALAFIL is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Torrent Pharmaceuticals Limited. The primary component is Tadalafil.

Product ID13668-567_2460f120-c14c-4b19-a927-b7e9908c43f2
NDC13668-567
Product TypeHuman Prescription Drug
Proprietary NameTADALAFIL
Generic NameTadalafil
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-03-26
Marketing CategoryANDA / ANDA
Application NumberANDA211839
Labeler NameTorrent Pharmaceuticals Limited
Substance NameTADALAFIL
Active Ingredient Strength10 mg/1
Pharm ClassesPhosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 13668-567-05

500 TABLET in 1 BOTTLE (13668-567-05)
Marketing Start Date2019-03-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 13668-567-74 [13668056774]

TADALAFIL TABLET
Marketing CategoryANDA
Application NumberANDA211839
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-26

NDC 13668-567-05 [13668056705]

TADALAFIL TABLET
Marketing CategoryANDA
Application NumberANDA211839
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-26

NDC 13668-567-30 [13668056730]

TADALAFIL TABLET
Marketing CategoryANDA
Application NumberANDA211839
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-03-26

NDC 13668-567-71 [13668056771]

TADALAFIL TABLET
Marketing CategoryANDA
Application NumberANDA211839
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-26

Drug Details

Active Ingredients

IngredientStrength
TADALAFIL10 mg/1

OpenFDA Data

SPL SET ID:3ea7612b-b004-43ef-accc-34c8ec5146b8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 484814
  • 402019
  • 757707
  • 403957
    • UPC Code
  • 0313668565058
  • 0313668568059
  • 0313668567052
  • 0313668566055

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