tadalafil

Generic: tadalafil

Labeler: solco healthcare us, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tadalafil
Generic Name tadalafil
Labeler solco healthcare us, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tadalafil 20 mg/1

Manufacturer
Solco Healthcare US, LLC

Identifiers & Regulatory

Product NDC 43547-033
Product ID 43547-033_bdb087ff-a428-434e-b23b-0437f8672219
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210609
Listing Expiration 2026-12-31
Marketing Start 2022-01-18

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 43547033
Hyphenated Format 43547-033

Supplemental Identifiers

RxCUI
402019 403957 484814 757707
UPC
0343547030032 0343547032036 0343547033033 0343547031039
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 ANDA210609 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (43547-033-03)
  • 500 TABLET in 1 BOTTLE (43547-033-50)
source: ndc

Packages (2)

43547-033-03 30 TABLET in 1 BOTTLE (43547-033-03) 43547-033-50 500 TABLET in 1 BOTTLE (43547-033-50)

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": "bdb087ff-a428-434e-b23b-0437f8672219", "openfda": {"nui": ["N0000175599", "N0000020026"], "upc": ["0343547030032", "0343547032036", "0343547033033", "0343547031039"], "unii": ["742SXX0ICT"], "rxcui": ["402019", "403957", "484814", "757707"], "spl_set_id": ["491cb72b-71f2-4df9-99f8-c02d93500103"], "pharm_class_epc": ["Phosphodiesterase 5 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 5 Inhibitors [MoA]"], "manufacturer_name": ["Solco Healthcare US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (43547-033-03)", "package_ndc": "43547-033-03", "marketing_start_date": "20241127"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (43547-033-50)", "package_ndc": "43547-033-50", "marketing_start_date": "20241127"}], "brand_name": "TADALAFIL", "product_id": "43547-033_bdb087ff-a428-434e-b23b-0437f8672219", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "43547-033", "generic_name": "tadalafil", "labeler_name": "Solco Healthcare US, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TADALAFIL", "active_ingredients": [{"name": "TADALAFIL", "strength": "20 mg/1"}], "application_number": "ANDA210609", "marketing_category": "ANDA", "marketing_start_date": "20220118", "listing_expiration_date": "20261231"}