tadalafil

Generic: tadalafil

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tadalafil
Generic Name tadalafil
Labeler proficient rx lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tadalafil 20 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-112
Product ID 82804-112_a080fd7b-7bde-40ad-ac8c-4c85453be8db
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 82804112
Hyphenated Format 82804-112

Supplemental Identifiers

RxCUI
402019
UPC
0382804112906
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
  • 20 mg/1
source: ndc
Packaging
  • 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-112-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-112-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-112-90)
source: ndc

Packages (3)

82804-112-10 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-112-10) 82804-112-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-112-30) 82804-112-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-112-90)

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": "a080fd7b-7bde-40ad-ac8c-4c85453be8db", "openfda": {"nui": ["N0000175599", "N0000020026"], "upc": ["0382804112906"], "unii": ["742SXX0ICT"], "rxcui": ["402019"], "spl_set_id": ["929e391e-b74b-4ccd-8690-16ffcece7a30"], "pharm_class_epc": ["Phosphodiesterase 5 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 5 Inhibitors [MoA]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-112-10)", "package_ndc": "82804-112-10", "marketing_start_date": "20240718"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-112-30)", "package_ndc": "82804-112-30", "marketing_start_date": "20240626"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-112-90)", "package_ndc": "82804-112-90", "marketing_start_date": "20240617"}], "brand_name": "tadalafil", "product_id": "82804-112_a080fd7b-7bde-40ad-ac8c-4c85453be8db", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "82804-112", "generic_name": "tadalafil", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "tadalafil", "active_ingredients": [{"name": "TADALAFIL", "strength": "20 mg/1"}], "application_number": "ANDA209250", "marketing_category": "ANDA", "marketing_start_date": "20190326", "listing_expiration_date": "20261231"}