lurasidone hydrochloride

Generic: lurasidone hydrochloride

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lurasidone hydrochloride
Generic Name lurasidone hydrochloride
Labeler zydus pharmaceuticals usa inc.
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

lurasidone hydrochloride 40 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-966
Product ID 68382-966_4583ae02-09cb-4dd4-b5e7-b3074f3b95aa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208052
Listing Expiration 2026-12-31
Marketing Start 2023-02-01

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68382966
Hyphenated Format 68382-966

Supplemental Identifiers

RxCUI
1040031 1040041 1235247 1297278 1431235
UPC
0368382967060 0368382968067 0368382859068 0368382965066
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 ANDA208052 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 100 TABLET, COATED in 1 BOTTLE (68382-966-01)
  • 500 TABLET, COATED in 1 BOTTLE (68382-966-05)
  • 30 TABLET, COATED in 1 BOTTLE (68382-966-06)
  • 90 TABLET, COATED in 1 BOTTLE (68382-966-16)
  • 100 BLISTER PACK in 1 CARTON (68382-966-77) / 1 TABLET, COATED in 1 BLISTER PACK (68382-966-30)
source: ndc

Packages (5)

68382-966-01 100 TABLET, COATED in 1 BOTTLE (68382-966-01) 68382-966-05 500 TABLET, COATED in 1 BOTTLE (68382-966-05) 68382-966-06 30 TABLET, COATED in 1 BOTTLE (68382-966-06) 68382-966-16 90 TABLET, COATED in 1 BOTTLE (68382-966-16) 68382-966-77 100 BLISTER PACK in 1 CARTON (68382-966-77) / 1 TABLET, COATED in 1 BLISTER PACK (68382-966-30)

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": "4583ae02-09cb-4dd4-b5e7-b3074f3b95aa", "openfda": {"upc": ["0368382967060", "0368382968067", "0368382859068", "0368382965066"], "unii": ["O0P4I5851I"], "rxcui": ["1040031", "1040041", "1235247", "1297278", "1431235"], "spl_set_id": ["bceb350e-4b88-4de1-9629-9629365a27a7"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (68382-966-01)", "package_ndc": "68382-966-01", "marketing_start_date": "20230201"}, {"sample": false, "description": "500 TABLET, COATED in 1 BOTTLE (68382-966-05)", "package_ndc": "68382-966-05", "marketing_start_date": "20230201"}, {"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (68382-966-06)", "package_ndc": "68382-966-06", "marketing_start_date": "20230323"}, {"sample": false, "description": "90 TABLET, COATED in 1 BOTTLE (68382-966-16)", "package_ndc": "68382-966-16", "marketing_start_date": "20230201"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (68382-966-77)  / 1 TABLET, COATED in 1 BLISTER PACK (68382-966-30)", "package_ndc": "68382-966-77", "marketing_start_date": "20230201"}], "brand_name": "Lurasidone hydrochloride", "product_id": "68382-966_4583ae02-09cb-4dd4-b5e7-b3074f3b95aa", "dosage_form": "TABLET, COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "68382-966", "generic_name": "Lurasidone hydrochloride", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lurasidone hydrochloride", "active_ingredients": [{"name": "LURASIDONE HYDROCHLORIDE", "strength": "40 mg/1"}], "application_number": "ANDA208052", "marketing_category": "ANDA", "marketing_start_date": "20230201", "listing_expiration_date": "20261231"}