tadalafil

Generic: tadalafil

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tadalafil
Generic Name tadalafil
Labeler asclemed usa, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tadalafil 5 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-541
Product ID 76420-541_f7777037-65b9-9411-e053-6294a90a37eb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208934
Listing Expiration 2026-12-31
Marketing Start 2020-02-19

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 76420541
Hyphenated Format 76420-541

Supplemental Identifiers

RxCUI
402019 403957 484814 757707
UNII
742SXX0ICT
NUI
N0000175599 N0000020026

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 ANDA208934 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (76420-541-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (76420-541-90)
source: ndc

Packages (2)

76420-541-30 30 TABLET, FILM COATED in 1 BOTTLE (76420-541-30) 76420-541-90 90 TABLET, FILM COATED in 1 BOTTLE (76420-541-90)

Ingredients (1)

tadalafil (5 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": "f7777037-65b9-9411-e053-6294a90a37eb", "openfda": {"nui": ["N0000175599", "N0000020026"], "unii": ["742SXX0ICT"], "rxcui": ["402019", "403957", "484814", "757707"], "spl_set_id": ["30ae58ed-5b56-4513-8eb3-eb4f89b78f9d"], "pharm_class_epc": ["Phosphodiesterase 5 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 5 Inhibitors [MoA]"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (76420-541-30)", "package_ndc": "76420-541-30", "marketing_start_date": "20230314"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (76420-541-90)", "package_ndc": "76420-541-90", "marketing_start_date": "20230314"}], "brand_name": "Tadalafil", "product_id": "76420-541_f7777037-65b9-9411-e053-6294a90a37eb", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "76420-541", "generic_name": "Tadalafil", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tadalafil", "active_ingredients": [{"name": "TADALAFIL", "strength": "5 mg/1"}], "application_number": "ANDA208934", "marketing_category": "ANDA", "marketing_start_date": "20200219", "listing_expiration_date": "20261231"}