tadalafil

Generic: tadalafil

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

Drug Facts

Product Profile

Brand Name tadalafil
Generic Name tadalafil
Labeler macleods pharmaceuticals limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tadalafil 20 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-278
Product ID 33342-278_8b7e0bf0-c13c-4d67-ba78-68fc6ef8b9b2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207290
Listing Expiration 2026-12-31
Marketing Start 2019-10-17

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 33342278
Hyphenated Format 33342-278

Supplemental Identifiers

RxCUI
2123194
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 ANDA207290 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (33342-278-07)
  • 60 TABLET, FILM COATED in 1 BOTTLE (33342-278-09)
source: ndc

Packages (2)

33342-278-07 30 TABLET, FILM COATED in 1 BOTTLE (33342-278-07) 33342-278-09 60 TABLET, FILM COATED in 1 BOTTLE (33342-278-09)

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": "8b7e0bf0-c13c-4d67-ba78-68fc6ef8b9b2", "openfda": {"nui": ["N0000175599", "N0000020026"], "unii": ["742SXX0ICT"], "rxcui": ["2123194"], "spl_set_id": ["93dd604f-8f38-4600-afe8-0fcc92fd2497"], "pharm_class_epc": ["Phosphodiesterase 5 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 5 Inhibitors [MoA]"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (33342-278-07)", "package_ndc": "33342-278-07", "marketing_start_date": "20191030"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (33342-278-09)", "package_ndc": "33342-278-09", "marketing_start_date": "20191030"}], "brand_name": "Tadalafil", "product_id": "33342-278_8b7e0bf0-c13c-4d67-ba78-68fc6ef8b9b2", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "33342-278", "generic_name": "Tadalafil", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tadalafil", "active_ingredients": [{"name": "TADALAFIL", "strength": "20 mg/1"}], "application_number": "ANDA207290", "marketing_category": "ANDA", "marketing_start_date": "20191017", "listing_expiration_date": "20261231"}