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 76420-855
Product ID 76420-855_38689a7c-8af1-e4b0-e063-6394a90a94d8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209250
Listing Expiration 2026-12-31
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 76420855
Hyphenated Format 76420-855

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 ANDA209250 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-855-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-855-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-855-30)
  • 2 BLISTER PACK in 1 CARTON (76420-855-33) / 15 TABLET, FILM COATED in 1 BLISTER PACK
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-855-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-855-90)
source: ndc

Packages (6)

76420-855-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-855-01) 76420-855-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-855-05) 76420-855-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-855-30) 76420-855-33 2 BLISTER PACK in 1 CARTON (76420-855-33) / 15 TABLET, FILM COATED in 1 BLISTER PACK 76420-855-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-855-60) 76420-855-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-855-90)

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": "38689a7c-8af1-e4b0-e063-6394a90a94d8", "openfda": {"nui": ["N0000175599", "N0000020026"], "unii": ["742SXX0ICT"], "rxcui": ["402019", "403957", "484814", "757707"], "spl_set_id": ["fa547e3d-455a-4926-9fd9-349930898502"], "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": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-855-01)", "package_ndc": "76420-855-01", "marketing_start_date": "20250128"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-855-05)", "package_ndc": "76420-855-05", "marketing_start_date": "20250128"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-855-30)", "package_ndc": "76420-855-30", "marketing_start_date": "20250128"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (76420-855-33)  / 15 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "76420-855-33", "marketing_start_date": "20250128"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-855-60)", "package_ndc": "76420-855-60", "marketing_start_date": "20250128"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-855-90)", "package_ndc": "76420-855-90", "marketing_start_date": "20250128"}], "brand_name": "tadalafil", "product_id": "76420-855_38689a7c-8af1-e4b0-e063-6394a90a94d8", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "76420-855", "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": "ANDA209250", "marketing_category": "ANDA", "marketing_start_date": "20190326", "listing_expiration_date": "20261231"}