tadalafil

Generic: tadalafil

Labeler: quallent pharmaceuticals health llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tadalafil
Generic Name tadalafil
Labeler quallent pharmaceuticals health llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tadalafil 5 mg/1

Manufacturer
Quallent Pharmaceuticals Health LLC

Identifiers & Regulatory

Product NDC 82009-077
Product ID 82009-077_01775afe-20a4-476e-8c27-f4d83a6d925c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209654
Listing Expiration 2026-12-31
Marketing Start 2023-07-19

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 82009077
Hyphenated Format 82009-077

Supplemental Identifiers

RxCUI
402019 403957
UPC
0382009077055 0382009079059
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 ANDA209654 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (82009-077-05)
source: ndc

Packages (1)

82009-077-05 500 TABLET in 1 BOTTLE (82009-077-05)

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": "01775afe-20a4-476e-8c27-f4d83a6d925c", "openfda": {"nui": ["N0000175599", "N0000020026"], "upc": ["0382009077055", "0382009079059"], "unii": ["742SXX0ICT"], "rxcui": ["402019", "403957"], "spl_set_id": ["dc14daa3-cae9-4751-9034-b0e9c18054b4"], "pharm_class_epc": ["Phosphodiesterase 5 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 5 Inhibitors [MoA]"], "manufacturer_name": ["Quallent Pharmaceuticals Health LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (82009-077-05)", "package_ndc": "82009-077-05", "marketing_start_date": "20230719"}], "brand_name": "Tadalafil", "product_id": "82009-077_01775afe-20a4-476e-8c27-f4d83a6d925c", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "82009-077", "generic_name": "Tadalafil", "labeler_name": "Quallent Pharmaceuticals Health LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tadalafil", "active_ingredients": [{"name": "TADALAFIL", "strength": "5 mg/1"}], "application_number": "ANDA209654", "marketing_category": "ANDA", "marketing_start_date": "20230719", "listing_expiration_date": "20261231"}