tadalafil

Generic: tadalafil

Labeler: accord healthcare inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tadalafil
Generic Name tadalafil
Labeler accord healthcare inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tadalafil 2.5 mg/1

Manufacturer
Accord Healthcare Inc.

Identifiers & Regulatory

Product NDC 16729-369
Product ID 16729-369_44e7e28b-88e4-784b-e063-6294a90a6002
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209167
Listing Expiration 2026-12-31
Marketing Start 2019-03-27

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 16729369
Hyphenated Format 16729-369

Supplemental Identifiers

RxCUI
402019 403957 484814 757707
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 ANDA209167 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (16729-369-10)
  • 500 TABLET, FILM COATED in 1 BOTTLE (16729-369-16)
source: ndc

Packages (2)

16729-369-10 30 TABLET, FILM COATED in 1 BOTTLE (16729-369-10) 16729-369-16 500 TABLET, FILM COATED in 1 BOTTLE (16729-369-16)

Ingredients (1)

tadalafil (2.5 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": "44e7e28b-88e4-784b-e063-6294a90a6002", "openfda": {"nui": ["N0000175599", "N0000020026"], "unii": ["742SXX0ICT"], "rxcui": ["402019", "403957", "484814", "757707"], "spl_set_id": ["eedf3ad9-7d40-496d-b1a9-6200010c18e1"], "pharm_class_epc": ["Phosphodiesterase 5 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 5 Inhibitors [MoA]"], "manufacturer_name": ["Accord Healthcare Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (16729-369-10)", "package_ndc": "16729-369-10", "marketing_start_date": "20190327"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (16729-369-16)", "package_ndc": "16729-369-16", "marketing_start_date": "20200505"}], "brand_name": "Tadalafil", "product_id": "16729-369_44e7e28b-88e4-784b-e063-6294a90a6002", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "16729-369", "generic_name": "Tadalafil", "labeler_name": "Accord Healthcare Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tadalafil", "active_ingredients": [{"name": "TADALAFIL", "strength": "2.5 mg/1"}], "application_number": "ANDA209167", "marketing_category": "ANDA", "marketing_start_date": "20190327", "listing_expiration_date": "20261231"}