NDC 65862-852

Tadalafil

Tadalafil

Tadalafil is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is Tadalafil.

Product ID65862-852_0345b81b-f946-4dd6-b49d-2a2bdd4c49c9
NDC65862-852
Product TypeHuman Prescription Drug
Proprietary NameTadalafil
Generic NameTadalafil
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-03-26
Marketing CategoryANDA / DRUG FOR FURTHER PROCESSING
Application NumberANDA206285
Labeler NameAurobindo Pharma Limited
Substance NameTADALAFIL
Active Ingredient Strength10 mg/1
Pharm ClassesPhosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 65862-852-05

500 TABLET, FILM COATED in 1 BOTTLE (65862-852-05)
Marketing Start Date2019-03-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65862-852-05 [65862085205]

Tadalafil TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206285
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-26

NDC 65862-852-30 [65862085230]

Tadalafil TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206285
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-26

NDC 65862-852-99 [65862085299]

Tadalafil TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206285
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-26

Drug Details

Active Ingredients

IngredientStrength
TADALAFIL10 mg/1

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.