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
Routes
ORAL
Active Ingredients

tadalafil 5 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-461
Product ID 71610-461_b5c51223-f994-41aa-8478-ed13dc51a908
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209654
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 71610461
Hyphenated Format 71610-461

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 ANDA209654 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 8 TABLET in 1 BOTTLE (71610-461-08)
  • 48 TABLET in 1 BOTTLE (71610-461-11)
  • 16 TABLET in 1 BOTTLE (71610-461-23)
source: ndc

Packages (3)

71610-461-08 8 TABLET in 1 BOTTLE (71610-461-08) 71610-461-11 48 TABLET in 1 BOTTLE (71610-461-11) 71610-461-23 16 TABLET in 1 BOTTLE (71610-461-23)

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": "b5c51223-f994-41aa-8478-ed13dc51a908", "openfda": {"nui": ["N0000175599", "N0000020026"], "unii": ["742SXX0ICT"], "rxcui": ["403957"], "spl_set_id": ["36350106-98bc-41fc-bede-8be5e6f54a8a"], "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 in 1 BOTTLE (71610-461-08)", "package_ndc": "71610-461-08", "marketing_start_date": "20200904"}, {"sample": false, "description": "48 TABLET in 1 BOTTLE (71610-461-11)", "package_ndc": "71610-461-11", "marketing_start_date": "20200904"}, {"sample": false, "description": "16 TABLET in 1 BOTTLE (71610-461-23)", "package_ndc": "71610-461-23", "marketing_start_date": "20200904"}], "brand_name": "Tadalafil", "product_id": "71610-461_b5c51223-f994-41aa-8478-ed13dc51a908", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "71610-461", "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": "ANDA209654", "marketing_category": "ANDA", "marketing_start_date": "20190326", "listing_expiration_date": "20261231"}