tadalafil

Generic: tadalafil

Labeler: northwind health company, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tadalafil
Generic Name tadalafil
Labeler northwind health company, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tadalafil 20 mg/1

Manufacturer
Northwind Health Company, LLC

Identifiers & Regulatory

Product NDC 51655-063
Product ID 51655-063_46ddbacb-b89b-1715-e063-6394a90a3c49
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206693
Listing Expiration 2027-12-31
Marketing Start 2022-09-27

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 51655063
Hyphenated Format 51655-063

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 ANDA206693 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-063-54)
  • 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-063-87)
source: ndc

Packages (2)

51655-063-54 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-063-54) 51655-063-87 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-063-87)

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": "46ddbacb-b89b-1715-e063-6394a90a3c49", "openfda": {"nui": ["N0000175599", "N0000020026"], "unii": ["742SXX0ICT"], "rxcui": ["402019"], "spl_set_id": ["f2a132af-d75e-2ca0-e053-2a95a90a332e"], "pharm_class_epc": ["Phosphodiesterase 5 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 5 Inhibitors [MoA]"], "manufacturer_name": ["Northwind Health Company, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-063-54)", "package_ndc": "51655-063-54", "marketing_start_date": "20220927"}, {"sample": false, "description": "6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-063-87)", "package_ndc": "51655-063-87", "marketing_start_date": "20220927"}], "brand_name": "Tadalafil", "product_id": "51655-063_46ddbacb-b89b-1715-e063-6394a90a3c49", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "51655-063", "generic_name": "Tadalafil", "labeler_name": "Northwind Health Company, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tadalafil", "active_ingredients": [{"name": "TADALAFIL", "strength": "20 mg/1"}], "application_number": "ANDA206693", "marketing_category": "ANDA", "marketing_start_date": "20220927", "listing_expiration_date": "20271231"}