lurasidone hydrochloride

Generic: lurasidone hydrochloride

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

Drug Facts

Product Profile

Brand Name lurasidone hydrochloride
Generic Name lurasidone hydrochloride
Labeler remedyrepack inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

lurasidone hydrochloride 40 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4117
Product ID 70518-4117_3d310ff4-f668-b9d5-e063-6394a90af777
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208047
Listing Expiration 2026-12-31
Marketing Start 2024-06-27

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184117
Hyphenated Format 70518-4117

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 hydrochloride (source: ndc)
Generic Name lurasidone hydrochloride (source: ndc)
Application Number ANDA208047 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4117-0)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4117-1)
source: ndc

Packages (2)

70518-4117-0 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4117-0) 70518-4117-1 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4117-1)

Ingredients (1)

lurasidone hydrochloride (40 mg/1)

Linked Drug Pages (1)

Lurasidone hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3d310ff4-f668-b9d5-e063-6394a90af777", "openfda": {"unii": ["O0P4I5851I"], "rxcui": ["1040031"], "spl_set_id": ["672d22f6-fad5-49db-9206-f924d02af181"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4117-0)", "package_ndc": "70518-4117-0", "marketing_start_date": "20240627"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4117-1)", "package_ndc": "70518-4117-1", "marketing_start_date": "20250823"}], "brand_name": "Lurasidone hydrochloride", "product_id": "70518-4117_3d310ff4-f668-b9d5-e063-6394a90af777", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "70518-4117", "generic_name": "Lurasidone hydrochloride", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lurasidone hydrochloride", "active_ingredients": [{"name": "LURASIDONE HYDROCHLORIDE", "strength": "40 mg/1"}], "application_number": "ANDA208047", "marketing_category": "ANDA", "marketing_start_date": "20240627", "listing_expiration_date": "20261231"}