tadalafil

Generic: tadalafil

Labeler: torrent pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tadalafil
Generic Name tadalafil
Labeler torrent pharmaceuticals limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tadalafil 10 mg/1

Manufacturer
Torrent Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 13668-567
Product ID 13668-567_8d94d098-d4f5-488c-8cc9-d21f32b727ec
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211839
Listing Expiration 2027-12-31
Marketing Start 2019-03-26

Pharmacologic Class

Established (EPC)
phosphodiesterase 5 inhibitor [epc]
Mechanism of Action
phosphodiesterase 5 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 13668567
Hyphenated Format 13668-567

Supplemental Identifiers

RxCUI
402019 403957 484814 757707
UPC
0313668565300 0313668566307 0313668568301 0313668567304
UNII
742SXX0ICT
NUI
N0000175599 N0000020026

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tadalafil (source: ndc)
Generic Name tadalafil (source: ndc)
Application Number ANDA211839 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (13668-567-05)
  • 30 TABLET in 1 BOTTLE (13668-567-30)
source: ndc

Packages (2)

13668-567-05 500 TABLET in 1 BOTTLE (13668-567-05) 13668-567-30 30 TABLET in 1 BOTTLE (13668-567-30)

Ingredients (1)

tadalafil (10 mg/1)

Linked Drug Pages (1)

TADALAFIL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8d94d098-d4f5-488c-8cc9-d21f32b727ec", "openfda": {"nui": ["N0000175599", "N0000020026"], "upc": ["0313668565300", "0313668566307", "0313668568301", "0313668567304"], "unii": ["742SXX0ICT"], "rxcui": ["402019", "403957", "484814", "757707"], "spl_set_id": ["3ea7612b-b004-43ef-accc-34c8ec5146b8"], "pharm_class_epc": ["Phosphodiesterase 5 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 5 Inhibitors [MoA]"], "manufacturer_name": ["Torrent Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (13668-567-05)", "package_ndc": "13668-567-05", "marketing_start_date": "20190326"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (13668-567-30)", "package_ndc": "13668-567-30", "marketing_start_date": "20190326"}], "brand_name": "TADALAFIL", "product_id": "13668-567_8d94d098-d4f5-488c-8cc9-d21f32b727ec", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "13668-567", "generic_name": "TADALAFIL", "labeler_name": "Torrent Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TADALAFIL", "active_ingredients": [{"name": "TADALAFIL", "strength": "10 mg/1"}], "application_number": "ANDA211839", "marketing_category": "ANDA", "marketing_start_date": "20190326", "listing_expiration_date": "20271231"}