tadalafil

Generic: tadalafil

Labeler: xlcare pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

tadalafil 2.5 mg/1

Manufacturer
XLCare Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 72865-104
Product ID 72865-104_28d63724-c672-207c-e063-6294a90af28d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209908
Listing Expiration 2026-12-31
Marketing Start 2024-12-10

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 72865104
Hyphenated Format 72865-104

Supplemental Identifiers

RxCUI
402019 403957 484814 757707
UPC
0372865106303 0372865104309 0372865108307 0372865107300
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 ANDA209908 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (72865-104-30)
source: ndc

Packages (1)

72865-104-30 30 TABLET, FILM COATED in 1 BOTTLE (72865-104-30)

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": "28d63724-c672-207c-e063-6294a90af28d", "openfda": {"nui": ["N0000175599", "N0000020026"], "upc": ["0372865106303", "0372865104309", "0372865108307", "0372865107300"], "unii": ["742SXX0ICT"], "rxcui": ["402019", "403957", "484814", "757707"], "spl_set_id": ["add6afb8-d38c-47a2-8c35-d5940667bb0c"], "pharm_class_epc": ["Phosphodiesterase 5 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 5 Inhibitors [MoA]"], "manufacturer_name": ["XLCare Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (72865-104-30)", "package_ndc": "72865-104-30", "marketing_start_date": "20241210"}], "brand_name": "Tadalafil", "product_id": "72865-104_28d63724-c672-207c-e063-6294a90af28d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "72865-104", "generic_name": "Tadalafil", "labeler_name": "XLCare Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tadalafil", "active_ingredients": [{"name": "TADALAFIL", "strength": "2.5 mg/1"}], "application_number": "ANDA209908", "marketing_category": "ANDA", "marketing_start_date": "20241210", "listing_expiration_date": "20261231"}