tadalafil

Generic: tadalafil

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tadalafil
Generic Name tadalafil
Labeler advanced rx of tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tadalafil 20 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0443
Product ID 80425-0443_248a470e-c977-fb5c-e063-6394a90abb66
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210420
Listing Expiration 2026-12-31
Marketing Start 2024-10-15

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 804250443
Hyphenated Format 80425-0443

Supplemental Identifiers

RxCUI
402019
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 ANDA210420 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 7 TABLET, FILM COATED in 1 BOTTLE (80425-0443-1)
source: ndc

Packages (1)

80425-0443-1 7 TABLET, FILM COATED in 1 BOTTLE (80425-0443-1)

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": "248a470e-c977-fb5c-e063-6394a90abb66", "openfda": {"nui": ["N0000175599", "N0000020026"], "unii": ["742SXX0ICT"], "rxcui": ["402019"], "spl_set_id": ["248a4705-1403-e94a-e063-6294a90a3544"], "pharm_class_epc": ["Phosphodiesterase 5 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 5 Inhibitors [MoA]"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "7 TABLET, FILM COATED in 1 BOTTLE (80425-0443-1)", "package_ndc": "80425-0443-1", "marketing_start_date": "20241015"}], "brand_name": "Tadalafil", "product_id": "80425-0443_248a470e-c977-fb5c-e063-6394a90abb66", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "80425-0443", "generic_name": "Tadalafil", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tadalafil", "active_ingredients": [{"name": "TADALAFIL", "strength": "20 mg/1"}], "application_number": "ANDA210420", "marketing_category": "ANDA", "marketing_start_date": "20241015", "listing_expiration_date": "20261231"}