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
Routes
ORAL
Active Ingredients

tadalafil 20 mg/1

Manufacturer
Northwind Health Company, LLC

Identifiers & Regulatory

Product NDC 82868-028
Product ID 82868-028_46dca45a-dcd4-7994-e063-6294a90a573a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206286
Listing Expiration 2026-12-31
Marketing Start 2023-11-16

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 82868028
Hyphenated Format 82868-028

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 ANDA206286 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 6 TABLET in 1 BOTTLE, PLASTIC (82868-028-06)
  • 15 TABLET in 1 BOTTLE, PLASTIC (82868-028-15)
source: ndc

Packages (2)

82868-028-06 6 TABLET in 1 BOTTLE, PLASTIC (82868-028-06) 82868-028-15 15 TABLET in 1 BOTTLE, PLASTIC (82868-028-15)

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": "46dca45a-dcd4-7994-e063-6294a90a573a", "openfda": {"nui": ["N0000175599", "N0000020026"], "unii": ["742SXX0ICT"], "rxcui": ["402019"], "spl_set_id": ["0afd0728-256a-293b-e063-6394a90a3c5f"], "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": "6 TABLET in 1 BOTTLE, PLASTIC (82868-028-06)", "package_ndc": "82868-028-06", "marketing_start_date": "20231121"}, {"sample": false, "description": "15 TABLET in 1 BOTTLE, PLASTIC (82868-028-15)", "package_ndc": "82868-028-15", "marketing_start_date": "20231116"}], "brand_name": "Tadalafil", "product_id": "82868-028_46dca45a-dcd4-7994-e063-6294a90a573a", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "82868-028", "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": "ANDA206286", "marketing_category": "ANDA", "marketing_start_date": "20231116", "listing_expiration_date": "20261231"}