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 5 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-603
Product ID 71610-603_14c0a7a9-5273-4ee8-e063-6294a90a13dc
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 71610603
Hyphenated Format 71610-603

Supplemental Identifiers

RxCUI
403957
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
  • 5 mg/1
source: ndc
Packaging
  • 8 TABLET, FILM COATED in 1 BOTTLE (71610-603-08)
  • 48 TABLET, FILM COATED in 1 BOTTLE (71610-603-11)
  • 16 TABLET, FILM COATED in 1 BOTTLE (71610-603-23)
  • 2940 TABLET, FILM COATED in 1 BOTTLE (71610-603-36)
source: ndc

Packages (4)

71610-603-08 8 TABLET, FILM COATED in 1 BOTTLE (71610-603-08) 71610-603-11 48 TABLET, FILM COATED in 1 BOTTLE (71610-603-11) 71610-603-23 16 TABLET, FILM COATED in 1 BOTTLE (71610-603-23) 71610-603-36 2940 TABLET, FILM COATED in 1 BOTTLE (71610-603-36)

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": "14c0a7a9-5273-4ee8-e063-6294a90a13dc", "openfda": {"nui": ["N0000175599", "N0000020026"], "unii": ["742SXX0ICT"], "rxcui": ["403957"], "spl_set_id": ["d1dd9d05-e9d3-49ea-aeda-047536a27037"], "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": "8 TABLET, FILM COATED in 1 BOTTLE (71610-603-08)", "package_ndc": "71610-603-08", "marketing_start_date": "20211018"}, {"sample": false, "description": "48 TABLET, FILM COATED in 1 BOTTLE (71610-603-11)", "package_ndc": "71610-603-11", "marketing_start_date": "20211018"}, {"sample": false, "description": "16 TABLET, FILM COATED in 1 BOTTLE (71610-603-23)", "package_ndc": "71610-603-23", "marketing_start_date": "20211018"}, {"sample": false, "description": "2940 TABLET, FILM COATED in 1 BOTTLE (71610-603-36)", "package_ndc": "71610-603-36", "marketing_start_date": "20240322"}], "brand_name": "Tadalafil", "product_id": "71610-603_14c0a7a9-5273-4ee8-e063-6294a90a13dc", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "71610-603", "generic_name": "Tadalafil", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tadalafil", "active_ingredients": [{"name": "TADALAFIL", "strength": "5 mg/1"}], "application_number": "ANDA209744", "marketing_category": "ANDA", "marketing_start_date": "20210121", "listing_expiration_date": "20261231"}