lurasidone hcl

Generic: lurasidone hcl

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lurasidone hcl
Generic Name lurasidone hcl
Labeler direct_rx
Dosage Form TABLET
Routes
ORAL
Active Ingredients

lurasidone hydrochloride 40 mg/1

Manufacturer
Direct_rx

Identifiers & Regulatory

Product NDC 72189-598
Product ID 72189-598_296811cf-cba9-16c2-e063-6294a90acfa6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208045
Listing Expiration 2026-12-31
Marketing Start 2024-12-16

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189598
Hyphenated Format 72189-598

Supplemental Identifiers

RxCUI
1040031
UNII
O0P4I5851I

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 lurasidone hcl (source: ndc)
Generic Name lurasidone hcl (source: ndc)
Application Number ANDA208045 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (72189-598-30)
source: ndc

Packages (1)

72189-598-30 30 TABLET in 1 BOTTLE (72189-598-30)

Ingredients (1)

lurasidone hydrochloride (40 mg/1)

Linked Drug Pages (1)

Lurasidone HCL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "296811cf-cba9-16c2-e063-6294a90acfa6", "openfda": {"unii": ["O0P4I5851I"], "rxcui": ["1040031"], "spl_set_id": ["296811cf-cba8-16c2-e063-6294a90acfa6"], "manufacturer_name": ["Direct_rx"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (72189-598-30)", "package_ndc": "72189-598-30", "marketing_start_date": "20241216"}], "brand_name": "Lurasidone HCL", "product_id": "72189-598_296811cf-cba9-16c2-e063-6294a90acfa6", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "72189-598", "generic_name": "Lurasidone HCL", "labeler_name": "Direct_rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lurasidone HCL", "active_ingredients": [{"name": "LURASIDONE HYDROCHLORIDE", "strength": "40 mg/1"}], "application_number": "ANDA208045", "marketing_category": "ANDA", "marketing_start_date": "20241216", "listing_expiration_date": "20261231"}