tadalafil

Generic: tadalafil

Labeler: nucare pharmaceuticals,inc..
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tadalafil
Generic Name tadalafil
Labeler nucare pharmaceuticals,inc..
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tadalafil 5 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc..

Identifiers & Regulatory

Product NDC 68071-3598
Product ID 68071-3598_1bfa0b78-af77-374d-e063-6394a90a944b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210609
Listing Expiration 2026-12-31
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 680713598
Hyphenated Format 68071-3598

Supplemental Identifiers

RxCUI
403957
UPC
0368071359862
UNII
742SXX0ICT
NUI
N0000175599 N0000020026

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
  • 10 TABLET in 1 BOTTLE (68071-3598-1)
  • 60 TABLET in 1 BOTTLE (68071-3598-6)
source: ndc

Packages (2)

68071-3598-1 10 TABLET in 1 BOTTLE (68071-3598-1) 68071-3598-6 60 TABLET in 1 BOTTLE (68071-3598-6)

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": "1bfa0b78-af77-374d-e063-6394a90a944b", "openfda": {"nui": ["N0000175599", "N0000020026"], "upc": ["0368071359862"], "unii": ["742SXX0ICT"], "rxcui": ["403957"], "spl_set_id": ["16f13179-7c87-aa6c-e063-6294a90a93eb"], "pharm_class_epc": ["Phosphodiesterase 5 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 5 Inhibitors [MoA]"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc.."]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET in 1 BOTTLE (68071-3598-1)", "package_ndc": "68071-3598-1", "marketing_start_date": "20240628"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (68071-3598-6)", "package_ndc": "68071-3598-6", "marketing_start_date": "20240425"}], "brand_name": "TADALAFIL", "product_id": "68071-3598_1bfa0b78-af77-374d-e063-6394a90a944b", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "68071-3598", "generic_name": "tadalafil", "labeler_name": "NuCare Pharmaceuticals,Inc..", "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": "20261231"}