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 20 mg/1

Manufacturer
Torrent Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 13668-581
Product ID 13668-581_1f85153f-5d3a-40d8-8570-1d969f4efa3c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212062
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 13668581
Hyphenated Format 13668-581

Supplemental Identifiers

RxCUI
2123194
UPC
0313668581300
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 ANDA212062 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (13668-581-30)
  • 60 TABLET in 1 BOTTLE (13668-581-60)
source: ndc

Packages (2)

13668-581-30 30 TABLET in 1 BOTTLE (13668-581-30) 13668-581-60 60 TABLET in 1 BOTTLE (13668-581-60)

Ingredients (1)

tadalafil (20 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": "1f85153f-5d3a-40d8-8570-1d969f4efa3c", "openfda": {"nui": ["N0000175599", "N0000020026"], "upc": ["0313668581300"], "unii": ["742SXX0ICT"], "rxcui": ["2123194"], "spl_set_id": ["88132351-7fee-47ef-8007-ef2777543299"], "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": "30 TABLET in 1 BOTTLE (13668-581-30)", "package_ndc": "13668-581-30", "marketing_start_date": "20190326"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (13668-581-60)", "package_ndc": "13668-581-60", "marketing_start_date": "20201121"}], "brand_name": "TADALAFIL", "product_id": "13668-581_1f85153f-5d3a-40d8-8570-1d969f4efa3c", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "13668-581", "generic_name": "TADALAFIL", "labeler_name": "Torrent Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TADALAFIL", "active_ingredients": [{"name": "TADALAFIL", "strength": "20 mg/1"}], "application_number": "ANDA212062", "marketing_category": "ANDA", "marketing_start_date": "20190326", "listing_expiration_date": "20271231"}