tadalafil

Generic: tadalafil

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tadalafil
Generic Name tadalafil
Labeler zydus pharmaceuticals usa inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tadalafil 10 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-898
Product ID 68382-898_5a958db7-5c0e-4cf0-9227-230886cf9bf8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206693
Listing Expiration 2026-12-31
Marketing Start 2019-03-27

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 68382898
Hyphenated Format 68382-898

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 ANDA206693 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (68382-898-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (68382-898-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (68382-898-06)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (68382-898-10)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68382-898-16)
  • 2 BLISTER PACK in 1 CARTON (68382-898-99) / 15 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (6)

68382-898-01 100 TABLET, FILM COATED in 1 BOTTLE (68382-898-01) 68382-898-05 500 TABLET, FILM COATED in 1 BOTTLE (68382-898-05) 68382-898-06 30 TABLET, FILM COATED in 1 BOTTLE (68382-898-06) 68382-898-10 1000 TABLET, FILM COATED in 1 BOTTLE (68382-898-10) 68382-898-16 90 TABLET, FILM COATED in 1 BOTTLE (68382-898-16) 68382-898-99 2 BLISTER PACK in 1 CARTON (68382-898-99) / 15 TABLET, FILM COATED in 1 BLISTER PACK

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": "5a958db7-5c0e-4cf0-9227-230886cf9bf8", "openfda": {"nui": ["N0000175599", "N0000020026"], "unii": ["742SXX0ICT"], "rxcui": ["402019", "403957", "484814", "757707"], "spl_set_id": ["cfe43ab8-8721-4db8-8810-f0072cf8f4d3"], "pharm_class_epc": ["Phosphodiesterase 5 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 5 Inhibitors [MoA]"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (68382-898-01)", "package_ndc": "68382-898-01", "marketing_start_date": "20190327"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (68382-898-05)", "package_ndc": "68382-898-05", "marketing_start_date": "20190327"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68382-898-06)", "package_ndc": "68382-898-06", "marketing_start_date": "20190327"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (68382-898-10)", "package_ndc": "68382-898-10", "marketing_start_date": "20190327"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68382-898-16)", "package_ndc": "68382-898-16", "marketing_start_date": "20190327"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (68382-898-99)  / 15 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "68382-898-99", "marketing_start_date": "20190327"}], "brand_name": "Tadalafil", "product_id": "68382-898_5a958db7-5c0e-4cf0-9227-230886cf9bf8", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "68382-898", "generic_name": "Tadalafil", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tadalafil", "active_ingredients": [{"name": "TADALAFIL", "strength": "10 mg/1"}], "application_number": "ANDA206693", "marketing_category": "ANDA", "marketing_start_date": "20190327", "listing_expiration_date": "20261231"}