tadalafil

Generic: tadalafil

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tadalafil
Generic Name tadalafil
Labeler bryant ranch prepack
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tadalafil 20 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-2583
Product ID 71335-2583_43a31ce4-0db9-417a-a1d9-80927c92a4cd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209250
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 713352583
Hyphenated Format 71335-2583

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 ANDA209250 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (71335-2583-1)
  • 10 TABLET, FILM COATED in 1 BOTTLE (71335-2583-2)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71335-2583-3)
  • 5 TABLET, FILM COATED in 1 BOTTLE (71335-2583-4)
  • 60 TABLET, FILM COATED in 1 BOTTLE (71335-2583-5)
  • 20 TABLET, FILM COATED in 1 BOTTLE (71335-2583-6)
  • 15 TABLET, FILM COATED in 1 BOTTLE (71335-2583-7)
  • 100 TABLET, FILM COATED in 1 BOTTLE (71335-2583-8)
source: ndc

Packages (8)

71335-2583-1 30 TABLET, FILM COATED in 1 BOTTLE (71335-2583-1) 71335-2583-2 10 TABLET, FILM COATED in 1 BOTTLE (71335-2583-2) 71335-2583-3 90 TABLET, FILM COATED in 1 BOTTLE (71335-2583-3) 71335-2583-4 5 TABLET, FILM COATED in 1 BOTTLE (71335-2583-4) 71335-2583-5 60 TABLET, FILM COATED in 1 BOTTLE (71335-2583-5) 71335-2583-6 20 TABLET, FILM COATED in 1 BOTTLE (71335-2583-6) 71335-2583-7 15 TABLET, FILM COATED in 1 BOTTLE (71335-2583-7) 71335-2583-8 100 TABLET, FILM COATED in 1 BOTTLE (71335-2583-8)

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": "43a31ce4-0db9-417a-a1d9-80927c92a4cd", "openfda": {"nui": ["N0000175599", "N0000020026"], "unii": ["742SXX0ICT"], "rxcui": ["402019"], "spl_set_id": ["24b82a6a-1b7e-42e6-b29b-41d4ee4d525f"], "pharm_class_epc": ["Phosphodiesterase 5 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 5 Inhibitors [MoA]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71335-2583-1)", "package_ndc": "71335-2583-1", "marketing_start_date": "20250403"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (71335-2583-2)", "package_ndc": "71335-2583-2", "marketing_start_date": "20250403"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71335-2583-3)", "package_ndc": "71335-2583-3", "marketing_start_date": "20250403"}, {"sample": false, "description": "5 TABLET, FILM COATED in 1 BOTTLE (71335-2583-4)", "package_ndc": "71335-2583-4", "marketing_start_date": "20250403"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71335-2583-5)", "package_ndc": "71335-2583-5", "marketing_start_date": "20250403"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (71335-2583-6)", "package_ndc": "71335-2583-6", "marketing_start_date": "20250403"}, {"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (71335-2583-7)", "package_ndc": "71335-2583-7", "marketing_start_date": "20250403"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (71335-2583-8)", "package_ndc": "71335-2583-8", "marketing_start_date": "20250403"}], "brand_name": "tadalafil", "product_id": "71335-2583_43a31ce4-0db9-417a-a1d9-80927c92a4cd", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "71335-2583", "generic_name": "tadalafil", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "tadalafil", "active_ingredients": [{"name": "TADALAFIL", "strength": "20 mg/1"}], "application_number": "ANDA209250", "marketing_category": "ANDA", "marketing_start_date": "20190326", "listing_expiration_date": "20261231"}