NDC 71610-354

Tadalafil

Tadalafil

Tadalafil is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Tadalafil.

Product ID71610-354_b5ab073b-8449-4044-be5e-fc4aee8835c1
NDC71610-354
Product TypeHuman Prescription Drug
Proprietary NameTadalafil
Generic NameTadalafil
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-10-09
Marketing CategoryANDA / ANDA
Application NumberANDA090141
Labeler NameAphena Pharma Solutions - Tennessee, LLC
Substance NameTADALAFIL
Active Ingredient Strength5 mg/1
Pharm ClassesPhosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 71610-354-11

48 TABLET, FILM COATED in 1 BOTTLE (71610-354-11)
Marketing Start Date2019-10-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71610-354-23 [71610035423]

Tadalafil TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090141
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-10-25

NDC 71610-354-11 [71610035411]

Tadalafil TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090141
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-10-25

NDC 71610-354-47 [71610035447]

Tadalafil TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090141
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-10-25

Drug Details

Active Ingredients

IngredientStrength
TADALAFIL5 mg/1

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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