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 20 mg/1

Manufacturer
Quallent Pharmaceuticals Health LLC

Identifiers & Regulatory

Product NDC 82009-080
Product ID 82009-080_f6dd0676-5e89-4c63-8a1c-7b594d23f304
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210392
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 82009080
Hyphenated Format 82009-080

Supplemental Identifiers

RxCUI
2123194
UPC
0382009080604
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 ANDA210392 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (82009-080-60)
source: ndc

Packages (1)

82009-080-60 60 TABLET in 1 BOTTLE (82009-080-60)

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": "f6dd0676-5e89-4c63-8a1c-7b594d23f304", "openfda": {"nui": ["N0000175599", "N0000020026"], "upc": ["0382009080604"], "unii": ["742SXX0ICT"], "rxcui": ["2123194"], "spl_set_id": ["84cb16c8-30ab-49f2-a6df-ec3c97bf6284"], "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": "60 TABLET in 1 BOTTLE (82009-080-60)", "package_ndc": "82009-080-60", "marketing_start_date": "20230719"}], "brand_name": "Tadalafil", "product_id": "82009-080_f6dd0676-5e89-4c63-8a1c-7b594d23f304", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "82009-080", "generic_name": "Tadalafil", "labeler_name": "Quallent Pharmaceuticals Health LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tadalafil", "active_ingredients": [{"name": "TADALAFIL", "strength": "20 mg/1"}], "application_number": "ANDA210392", "marketing_category": "ANDA", "marketing_start_date": "20230719", "listing_expiration_date": "20261231"}