tadalafil

Generic: tadalafil

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

Drug Facts

Product Profile

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

tadalafil 5 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8465
Product ID 68788-8465_a2d04de6-0652-4040-9aa3-9575514262b8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210609
Listing Expiration 2026-12-31
Marketing Start 2023-06-23

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 687888465
Hyphenated Format 68788-8465

Supplemental Identifiers

RxCUI
403957
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
  • 15 TABLET in 1 BOTTLE (68788-8465-1)
  • 20 TABLET in 1 BOTTLE (68788-8465-2)
source: ndc

Packages (2)

68788-8465-1 15 TABLET in 1 BOTTLE (68788-8465-1) 68788-8465-2 20 TABLET in 1 BOTTLE (68788-8465-2)

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": "a2d04de6-0652-4040-9aa3-9575514262b8", "openfda": {"nui": ["N0000175599", "N0000020026"], "unii": ["742SXX0ICT"], "rxcui": ["403957"], "spl_set_id": ["66e24ced-0008-40cb-b242-9d9add1f665c"], "pharm_class_epc": ["Phosphodiesterase 5 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 5 Inhibitors [MoA]"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET in 1 BOTTLE (68788-8465-1)", "package_ndc": "68788-8465-1", "marketing_start_date": "20230623"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (68788-8465-2)", "package_ndc": "68788-8465-2", "marketing_start_date": "20230623"}], "brand_name": "TADALAFIL", "product_id": "68788-8465_a2d04de6-0652-4040-9aa3-9575514262b8", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "68788-8465", "generic_name": "tadalafil", "labeler_name": "Preferred 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": "20230623", "listing_expiration_date": "20261231"}