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 5 mg/1

Manufacturer
Solco Healthcare US, LLC

Identifiers & Regulatory

Product NDC 43547-049
Product ID 43547-049_b7c42c71-e6fa-4e5d-afe3-617dc236a69f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210609
Listing Expiration 2027-12-31
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 43547049
Hyphenated Format 43547-049

Supplemental Identifiers

RxCUI
402019 403957 484814 757707
UPC
0343547051037 0343547049034 0343547047030 0343547050030
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
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (43547-049-03)
  • 1000 TABLET in 1 BOTTLE (43547-049-11)
  • 500 TABLET in 1 BOTTLE (43547-049-50)
source: ndc

Packages (3)

43547-049-03 30 TABLET in 1 BOTTLE (43547-049-03) 43547-049-11 1000 TABLET in 1 BOTTLE (43547-049-11) 43547-049-50 500 TABLET in 1 BOTTLE (43547-049-50)

Ingredients (1)

tadalafil (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": "b7c42c71-e6fa-4e5d-afe3-617dc236a69f", "openfda": {"nui": ["N0000175599", "N0000020026"], "upc": ["0343547051037", "0343547049034", "0343547047030", "0343547050030"], "unii": ["742SXX0ICT"], "rxcui": ["402019", "403957", "484814", "757707"], "spl_set_id": ["05640a4d-afb7-42ae-a5bb-77dbc8412356"], "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 (43547-049-03)", "package_ndc": "43547-049-03", "marketing_start_date": "20220118"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (43547-049-11)", "package_ndc": "43547-049-11", "marketing_start_date": "20220118"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (43547-049-50)", "package_ndc": "43547-049-50", "marketing_start_date": "20220118"}], "brand_name": "TADALAFIL", "product_id": "43547-049_b7c42c71-e6fa-4e5d-afe3-617dc236a69f", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "43547-049", "generic_name": "tadalafil", "labeler_name": "Solco Healthcare US, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TADALAFIL", "active_ingredients": [{"name": "TADALAFIL", "strength": "5 mg/1"}], "application_number": "ANDA210609", "marketing_category": "ANDA", "marketing_start_date": "20220118", "listing_expiration_date": "20271231"}