tadalafil

Generic: tadalafil

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tadalafil
Generic Name tadalafil
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tadalafil 5 mg/1

Manufacturer
PD-RX Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-324
Product ID 72789-324_40bb2f8b-c4c1-4ec3-e063-6394a90ae8dc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215556
Listing Expiration 2026-12-31
Marketing Start 2023-04-01

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 72789324
Hyphenated Format 72789-324

Supplemental Identifiers

RxCUI
403957
UPC
0372789324906
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 ANDA215556 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-324-90)
source: ndc

Packages (1)

72789-324-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-324-90)

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": "40bb2f8b-c4c1-4ec3-e063-6394a90ae8dc", "openfda": {"nui": ["N0000175599", "N0000020026"], "upc": ["0372789324906"], "unii": ["742SXX0ICT"], "rxcui": ["403957"], "spl_set_id": ["fc7596dd-42d3-af7c-e053-6294a90af01e"], "pharm_class_epc": ["Phosphodiesterase 5 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 5 Inhibitors [MoA]"], "manufacturer_name": ["PD-RX Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-324-90)", "package_ndc": "72789-324-90", "marketing_start_date": "20230524"}], "brand_name": "tadalafil", "product_id": "72789-324_40bb2f8b-c4c1-4ec3-e063-6394a90ae8dc", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "72789-324", "generic_name": "Tadalafil", "labeler_name": "PD-RX Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "tadalafil", "active_ingredients": [{"name": "TADALAFIL", "strength": "5 mg/1"}], "application_number": "ANDA215556", "marketing_category": "ANDA", "marketing_start_date": "20230401", "listing_expiration_date": "20261231"}