lurasidone hydrochloride

Generic: lurasidone hydrochloride

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lurasidone hydrochloride
Generic Name lurasidone hydrochloride
Labeler coupler llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

lurasidone hydrochloride 40 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1637
Product ID 67046-1637_4742c86b-0f0d-1222-e063-6394a90a6ab0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213248
Listing Expiration 2026-12-31
Marketing Start 2025-12-31

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 670461637
Hyphenated Format 67046-1637

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 ANDA213248 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1637-3)
source: ndc

Packages (1)

67046-1637-3 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1637-3)

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": "4742c86b-0f0d-1222-e063-6394a90a6ab0", "openfda": {"unii": ["O0P4I5851I"], "rxcui": ["1040031"], "spl_set_id": ["4742c2fd-303b-da08-e063-6294a90a7621"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1637-3)", "package_ndc": "67046-1637-3", "marketing_start_date": "20251231"}], "brand_name": "Lurasidone Hydrochloride", "product_id": "67046-1637_4742c86b-0f0d-1222-e063-6394a90a6ab0", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "67046-1637", "generic_name": "Lurasidone Hydrochloride", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lurasidone Hydrochloride", "active_ingredients": [{"name": "LURASIDONE HYDROCHLORIDE", "strength": "40 mg/1"}], "application_number": "ANDA213248", "marketing_category": "ANDA", "marketing_start_date": "20251231", "listing_expiration_date": "20261231"}