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 20 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-903
Product ID 71610-903_351dae30-b57e-b988-e063-6394a90a47f2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210609
Listing Expiration 2026-12-31
Marketing Start 2022-01-18

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 71610903
Hyphenated Format 71610-903

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 ANDA210609 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 4 TABLET in 1 BOTTLE (71610-903-04)
  • 12 TABLET in 1 BOTTLE (71610-903-12)
  • 600 TABLET in 1 BOTTLE (71610-903-31)
  • 18 TABLET in 1 BOTTLE (71610-903-52)
source: ndc

Packages (4)

71610-903-04 4 TABLET in 1 BOTTLE (71610-903-04) 71610-903-12 12 TABLET in 1 BOTTLE (71610-903-12) 71610-903-31 600 TABLET in 1 BOTTLE (71610-903-31) 71610-903-52 18 TABLET in 1 BOTTLE (71610-903-52)

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": "351dae30-b57e-b988-e063-6394a90a47f2", "openfda": {"nui": ["N0000175599", "N0000020026"], "unii": ["742SXX0ICT"], "rxcui": ["402019"], "spl_set_id": ["34684fe8-9bf3-47fd-e063-6394a90ac80f"], "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 in 1 BOTTLE (71610-903-04)", "package_ndc": "71610-903-04", "marketing_start_date": "20250501"}, {"sample": false, "description": "12 TABLET in 1 BOTTLE (71610-903-12)", "package_ndc": "71610-903-12", "marketing_start_date": "20250501"}, {"sample": false, "description": "600 TABLET in 1 BOTTLE (71610-903-31)", "package_ndc": "71610-903-31", "marketing_start_date": "20250513"}, {"sample": false, "description": "18 TABLET in 1 BOTTLE (71610-903-52)", "package_ndc": "71610-903-52", "marketing_start_date": "20250501"}], "brand_name": "TADALAFIL", "product_id": "71610-903_351dae30-b57e-b988-e063-6394a90a47f2", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "71610-903", "generic_name": "tadalafil", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TADALAFIL", "active_ingredients": [{"name": "TADALAFIL", "strength": "20 mg/1"}], "application_number": "ANDA210609", "marketing_category": "ANDA", "marketing_start_date": "20220118", "listing_expiration_date": "20261231"}