NDC 71610-303

TADALAFIL

Tadalafil

TADALAFIL 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 ID71610-303_a04f5824-f355-4b98-b7cd-782233f0a64a
NDC71610-303
Product TypeHuman Prescription Drug
Proprietary NameTADALAFIL
Generic NameTadalafil
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-03-26
Marketing CategoryANDA / ANDA
Application NumberANDA211839
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 Through2020-12-31

Packaging

NDC 71610-303-04

4 TABLET in 1 BOTTLE (71610-303-04)
Marketing Start Date2019-07-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71610-303-04 [71610030304]

TADALAFIL TABLET
Marketing CategoryANDA
Application NumberANDA211839
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-07-10

NDC 71610-303-06 [71610030306]

TADALAFIL TABLET
Marketing CategoryANDA
Application NumberANDA211839
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-07-10

NDC 71610-303-12 [71610030312]

TADALAFIL TABLET
Marketing CategoryANDA
Application NumberANDA211839
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-07-10

Drug Details

Active Ingredients

IngredientStrength
TADALAFIL20 mg/1

OpenFDA Data

SPL SET ID:721e4488-b2da-4c47-bc5c-8226adf1296b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 402019

    • 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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