tadalafil

Generic: tadalafil

Labeler: burel pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tadalafil
Generic Name tadalafil
Labeler burel pharmaceuticals, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tadalafil 20 mg/1

Manufacturer
Burel Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 35573-463
Product ID 35573-463_da1eee2b-ebe6-4af3-ad52-2b349a360a9a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215556
Listing Expiration 2027-12-31
Marketing Start 2023-04-01

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 35573463
Hyphenated Format 35573-463

Supplemental Identifiers

RxCUI
402019 403957 484814 757707
UPC
0335573463304 0335573462307
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 ANDA215556 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (35573-463-30)
source: ndc

Packages (1)

35573-463-30 30 TABLET, FILM COATED in 1 BOTTLE (35573-463-30)

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": "da1eee2b-ebe6-4af3-ad52-2b349a360a9a", "openfda": {"nui": ["N0000175599", "N0000020026"], "upc": ["0335573463304", "0335573462307"], "unii": ["742SXX0ICT"], "rxcui": ["402019", "403957", "484814", "757707"], "spl_set_id": ["a2e7f393-5cfc-45e5-b87d-9e8abc8e4355"], "pharm_class_epc": ["Phosphodiesterase 5 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 5 Inhibitors [MoA]"], "manufacturer_name": ["Burel Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (35573-463-30)", "package_ndc": "35573-463-30", "marketing_start_date": "20230401"}], "brand_name": "tadalafil", "product_id": "35573-463_da1eee2b-ebe6-4af3-ad52-2b349a360a9a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "35573-463", "generic_name": "Tadalafil", "labeler_name": "Burel Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "tadalafil", "active_ingredients": [{"name": "TADALAFIL", "strength": "20 mg/1"}], "application_number": "ANDA215556", "marketing_category": "ANDA", "marketing_start_date": "20230401", "listing_expiration_date": "20271231"}