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 40 mg/1

Manufacturer
MAJOR PHARMACEUTICALS

Identifiers & Regulatory

Product NDC 0904-7422
Product ID 0904-7422_cecfd4c8-bff3-44fa-b360-b3e8a8e955f5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208037
Listing Expiration 2026-12-31
Marketing Start 2023-02-09

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047422
Hyphenated Format 0904-7422

Supplemental Identifiers

RxCUI
1040031 1040041 1235247 1297278 1431235
UPC
0309047422463 0309047423460 0309047424467 0309047425464 0309047421466
UNII
O0P4I5851I

Packaging Origin

Original Packager
true

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 ANDA208037 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (0904-7422-46)
source: ndc

Packages (1)

0904-7422-46 30 TABLET, FILM COATED in 1 BOTTLE (0904-7422-46)

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": "cecfd4c8-bff3-44fa-b360-b3e8a8e955f5", "openfda": {"upc": ["0309047422463", "0309047423460", "0309047424467", "0309047425464", "0309047421466"], "unii": ["O0P4I5851I"], "rxcui": ["1040031", "1040041", "1235247", "1297278", "1431235"], "spl_set_id": ["cecfd4c8-bff3-44fa-b360-b3e8a8e955f5"], "manufacturer_name": ["MAJOR PHARMACEUTICALS"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0904-7422-46)", "package_ndc": "0904-7422-46", "marketing_start_date": "20240105"}], "brand_name": "lurasidone hydrochloride", "product_id": "0904-7422_cecfd4c8-bff3-44fa-b360-b3e8a8e955f5", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "0904-7422", "generic_name": "lurasidone hydrochloride", "labeler_name": "MAJOR PHARMACEUTICALS", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "lurasidone hydrochloride", "active_ingredients": [{"name": "LURASIDONE HYDROCHLORIDE", "strength": "40 mg/1"}], "application_number": "ANDA208037", "marketing_category": "ANDA", "marketing_start_date": "20230209", "listing_expiration_date": "20261231"}