tadalafil

Generic: tadalafil

Labeler: direct rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tadalafil
Generic Name tadalafil
Labeler direct rx
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tadalafil 5 mg/1

Manufacturer
direct rx

Identifiers & Regulatory

Product NDC 72189-145
Product ID 72189-145_397f5fde-810b-642f-e063-6294a90ae47b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209654
Listing Expiration 2026-12-31
Marketing Start 2020-11-12

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 72189145
Hyphenated Format 72189-145

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 ANDA209654 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (72189-145-30)
  • 90 TABLET in 1 BOTTLE (72189-145-90)
source: ndc

Packages (2)

72189-145-30 30 TABLET in 1 BOTTLE (72189-145-30) 72189-145-90 90 TABLET in 1 BOTTLE (72189-145-90)

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": "397f5fde-810b-642f-e063-6294a90ae47b", "openfda": {"nui": ["N0000175599", "N0000020026"], "unii": ["742SXX0ICT"], "rxcui": ["403957"], "spl_set_id": ["b3ee8325-bcb2-43fd-e053-2a95a90a08c8"], "pharm_class_epc": ["Phosphodiesterase 5 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 5 Inhibitors [MoA]"], "manufacturer_name": ["direct rx"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (72189-145-30)", "package_ndc": "72189-145-30", "marketing_start_date": "20201112"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (72189-145-90)", "package_ndc": "72189-145-90", "marketing_start_date": "20201112"}], "brand_name": "TADALAFIL", "product_id": "72189-145_397f5fde-810b-642f-e063-6294a90ae47b", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "72189-145", "generic_name": "TADALAFIL", "labeler_name": "direct rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TADALAFIL", "active_ingredients": [{"name": "TADALAFIL", "strength": "5 mg/1"}], "application_number": "ANDA209654", "marketing_category": "ANDA", "marketing_start_date": "20201112", "listing_expiration_date": "20261231"}