lurasidone hydrochloride

Generic: lurasidone hydrochloride

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

lurasidone hydrochloride 40 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-420
Product ID 33342-420_f4eb6157-0321-467a-a06b-69c2970eda71
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212124
Listing Expiration 2026-12-31
Marketing Start 2023-06-09

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342420
Hyphenated Format 33342-420

Supplemental Identifiers

RxCUI
1040031 1040041 1235247 1297278 1431235
UPC
0333342420107 0333342423108 0333342419101 0333342420077 0333342419071 0333342423078 0333342422101
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 ANDA212124 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (33342-420-07)
  • 90 TABLET, FILM COATED in 1 BOTTLE (33342-420-10)
source: ndc

Packages (2)

33342-420-07 30 TABLET, FILM COATED in 1 BOTTLE (33342-420-07) 33342-420-10 90 TABLET, FILM COATED in 1 BOTTLE (33342-420-10)

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": "f4eb6157-0321-467a-a06b-69c2970eda71", "openfda": {"upc": ["0333342420107", "0333342423108", "0333342419101", "0333342420077", "0333342419071", "0333342423078", "0333342422101"], "unii": ["O0P4I5851I"], "rxcui": ["1040031", "1040041", "1235247", "1297278", "1431235"], "spl_set_id": ["2b07a830-93ba-427a-95fc-5138a6309f1e"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (33342-420-07)", "package_ndc": "33342-420-07", "marketing_start_date": "20230609"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (33342-420-10)", "package_ndc": "33342-420-10", "marketing_start_date": "20230609"}], "brand_name": "lurasidone hydrochloride", "product_id": "33342-420_f4eb6157-0321-467a-a06b-69c2970eda71", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "33342-420", "generic_name": "lurasidone hydrochloride", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "lurasidone hydrochloride", "active_ingredients": [{"name": "LURASIDONE HYDROCHLORIDE", "strength": "40 mg/1"}], "application_number": "ANDA212124", "marketing_category": "ANDA", "marketing_start_date": "20230609", "listing_expiration_date": "20261231"}