tadalafil

Generic: tadalafil

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tadalafil
Generic Name tadalafil
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tadalafil 10 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-581
Product ID 71610-581_21f23cde-ebd8-aa67-e063-6394a90a7150
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209744
Listing Expiration 2026-12-31
Marketing Start 2021-01-21

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 71610581
Hyphenated Format 71610-581

Supplemental Identifiers

RxCUI
484814
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 ANDA209744 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 4 TABLET, FILM COATED in 1 BOTTLE (71610-581-04)
  • 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-581-06)
  • 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-581-12)
  • 1440 TABLET, FILM COATED in 1 BOTTLE (71610-581-39)
  • 18 TABLET, FILM COATED in 1 BOTTLE (71610-581-52)
source: ndc

Packages (5)

71610-581-04 4 TABLET, FILM COATED in 1 BOTTLE (71610-581-04) 71610-581-06 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-581-06) 71610-581-12 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-581-12) 71610-581-39 1440 TABLET, FILM COATED in 1 BOTTLE (71610-581-39) 71610-581-52 18 TABLET, FILM COATED in 1 BOTTLE (71610-581-52)

Ingredients (1)

tadalafil (10 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": "21f23cde-ebd8-aa67-e063-6394a90a7150", "openfda": {"nui": ["N0000175599", "N0000020026"], "unii": ["742SXX0ICT"], "rxcui": ["484814"], "spl_set_id": ["f2e8821e-04c9-4812-8c9e-39340775cc6e"], "pharm_class_epc": ["Phosphodiesterase 5 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 5 Inhibitors [MoA]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "4 TABLET, FILM COATED in 1 BOTTLE (71610-581-04)", "package_ndc": "71610-581-04", "marketing_start_date": "20210712"}, {"sample": false, "description": "6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-581-06)", "package_ndc": "71610-581-06", "marketing_start_date": "20230201"}, {"sample": false, "description": "12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-581-12)", "package_ndc": "71610-581-12", "marketing_start_date": "20210712"}, {"sample": false, "description": "1440 TABLET, FILM COATED in 1 BOTTLE (71610-581-39)", "package_ndc": "71610-581-39", "marketing_start_date": "20240403"}, {"sample": false, "description": "18 TABLET, FILM COATED in 1 BOTTLE (71610-581-52)", "package_ndc": "71610-581-52", "marketing_start_date": "20240905"}], "brand_name": "Tadalafil", "product_id": "71610-581_21f23cde-ebd8-aa67-e063-6394a90a7150", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "71610-581", "generic_name": "Tadalafil", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tadalafil", "active_ingredients": [{"name": "TADALAFIL", "strength": "10 mg/1"}], "application_number": "ANDA209744", "marketing_category": "ANDA", "marketing_start_date": "20210121", "listing_expiration_date": "20261231"}