tadalafil

Generic: tadalafil

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tadalafil
Generic Name tadalafil
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tadalafil 10 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-852
Product ID 65862-852_44ab9fdc-f741-47c8-9570-8d24b0f0d106
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206285
Listing Expiration 2026-12-31
Marketing Start 2019-03-26

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 65862852
Hyphenated Format 65862-852

Supplemental Identifiers

RxCUI
402019 403957 484814 757707
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 ANDA206285 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (65862-852-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (65862-852-30)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (65862-852-99)
source: ndc

Packages (3)

65862-852-05 500 TABLET, FILM COATED in 1 BOTTLE (65862-852-05) 65862-852-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-852-30) 65862-852-99 1000 TABLET, FILM COATED in 1 BOTTLE (65862-852-99)

Ingredients (1)

tadalafil (10 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": "44ab9fdc-f741-47c8-9570-8d24b0f0d106", "openfda": {"nui": ["N0000175599", "N0000020026"], "unii": ["742SXX0ICT"], "rxcui": ["402019", "403957", "484814", "757707"], "spl_set_id": ["0345b81b-f946-4dd6-b49d-2a2bdd4c49c9"], "pharm_class_epc": ["Phosphodiesterase 5 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 5 Inhibitors [MoA]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (65862-852-05)", "package_ndc": "65862-852-05", "marketing_start_date": "20190326"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65862-852-30)", "package_ndc": "65862-852-30", "marketing_start_date": "20190326"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (65862-852-99)", "package_ndc": "65862-852-99", "marketing_start_date": "20190326"}], "brand_name": "Tadalafil", "product_id": "65862-852_44ab9fdc-f741-47c8-9570-8d24b0f0d106", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "65862-852", "generic_name": "Tadalafil", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tadalafil", "active_ingredients": [{"name": "TADALAFIL", "strength": "10 mg/1"}], "application_number": "ANDA206285", "marketing_category": "ANDA", "marketing_start_date": "20190326", "listing_expiration_date": "20261231"}