lurasidone hydrochloride

Generic: lurasidone hydrochloride

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

lurasidone hydrochloride 80 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7358
Product ID 0904-7358_382b3af6-5685-44e2-b310-76fee0d2e0da
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212244
Listing Expiration 2026-12-31
Marketing Start 2023-01-04

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047358
Hyphenated Format 0904-7358

Supplemental Identifiers

RxCUI
1040031 1040041 1235247 1297278 1431235
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 ANDA212244 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-7358-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7358-61 100 BLISTER PACK in 1 CARTON (0904-7358-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

lurasidone hydrochloride (80 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": "382b3af6-5685-44e2-b310-76fee0d2e0da", "openfda": {"unii": ["O0P4I5851I"], "rxcui": ["1040031", "1040041", "1235247", "1297278", "1431235"], "spl_set_id": ["d8b9ba36-fb02-4f52-b0ed-7fdd81d50c4c"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-7358-61)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-7358-61", "marketing_start_date": "20230220"}], "brand_name": "lurasidone hydrochloride", "product_id": "0904-7358_382b3af6-5685-44e2-b310-76fee0d2e0da", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "0904-7358", "generic_name": "lurasidone hydrochloride", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "lurasidone hydrochloride", "active_ingredients": [{"name": "LURASIDONE HYDROCHLORIDE", "strength": "80 mg/1"}], "application_number": "ANDA212244", "marketing_category": "ANDA", "marketing_start_date": "20230104", "listing_expiration_date": "20261231"}