tadalafil

Generic: tadalafil

Labeler: upsher-smith laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tadalafil
Generic Name tadalafil
Labeler upsher-smith laboratories, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tadalafil 20 mg/1

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 24979-730
Product ID 24979-730_555edf7e-85bf-492f-8e14-c53f72aa5b38
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210420
Listing Expiration 2027-12-31
Marketing Start 2024-04-07

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 24979730
Hyphenated Format 24979-730

Supplemental Identifiers

RxCUI
402019 403957 484814 757707
UPC
0324979727028 0324979728025 0324979730448 0324979730066 0324979729695 0324979729060
UNII
742SXX0ICT
NUI
N0000175599 N0000020026

Packaging Origin

Original Packager
true

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 ANDA210420 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (24979-730-06)
  • 120 TABLET, FILM COATED in 1 BOTTLE (24979-730-44)
source: ndc

Packages (2)

24979-730-06 30 TABLET, FILM COATED in 1 BOTTLE (24979-730-06) 24979-730-44 120 TABLET, FILM COATED in 1 BOTTLE (24979-730-44)

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": "555edf7e-85bf-492f-8e14-c53f72aa5b38", "openfda": {"nui": ["N0000175599", "N0000020026"], "upc": ["0324979727028", "0324979728025", "0324979730448", "0324979730066", "0324979729695", "0324979729060"], "unii": ["742SXX0ICT"], "rxcui": ["402019", "403957", "484814", "757707"], "spl_set_id": ["ae801b15-0462-44af-99a4-affe3eed899a"], "pharm_class_epc": ["Phosphodiesterase 5 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 5 Inhibitors [MoA]"], "manufacturer_name": ["Upsher-Smith Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (24979-730-06)", "package_ndc": "24979-730-06", "marketing_start_date": "20240407"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (24979-730-44)", "package_ndc": "24979-730-44", "marketing_start_date": "20240407"}], "brand_name": "Tadalafil", "product_id": "24979-730_555edf7e-85bf-492f-8e14-c53f72aa5b38", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "24979-730", "generic_name": "Tadalafil", "labeler_name": "Upsher-Smith Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tadalafil", "active_ingredients": [{"name": "TADALAFIL", "strength": "20 mg/1"}], "application_number": "ANDA210420", "marketing_category": "ANDA", "marketing_start_date": "20240407", "listing_expiration_date": "20271231"}