lurasidone hydrochloride

Generic: lurasidone hydrochloride

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lurasidone hydrochloride
Generic Name lurasidone hydrochloride
Labeler zydus lifesciences limited
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

lurasidone hydrochloride 60 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1736
Product ID 70771-1736_b82674a0-84e9-4431-9041-e5c360bbdaca
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 707711736
Hyphenated Format 70771-1736

Supplemental Identifiers

RxCUI
1040031 1040041 1235247 1297278 1431235
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
  • 60 mg/1
source: ndc
Packaging
  • 100 TABLET, COATED in 1 BOTTLE (70771-1736-1)
  • 30 TABLET, COATED in 1 BOTTLE (70771-1736-3)
  • 10 BLISTER PACK in 1 CARTON (70771-1736-4) / 10 TABLET, COATED in 1 BLISTER PACK (70771-1736-2)
  • 500 TABLET, COATED in 1 BOTTLE (70771-1736-5)
  • 90 TABLET, COATED in 1 BOTTLE (70771-1736-9)
source: ndc

Packages (5)

70771-1736-1 100 TABLET, COATED in 1 BOTTLE (70771-1736-1) 70771-1736-3 30 TABLET, COATED in 1 BOTTLE (70771-1736-3) 70771-1736-4 10 BLISTER PACK in 1 CARTON (70771-1736-4) / 10 TABLET, COATED in 1 BLISTER PACK (70771-1736-2) 70771-1736-5 500 TABLET, COATED in 1 BOTTLE (70771-1736-5) 70771-1736-9 90 TABLET, COATED in 1 BOTTLE (70771-1736-9)

Ingredients (1)

lurasidone hydrochloride (60 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": "b82674a0-84e9-4431-9041-e5c360bbdaca", "openfda": {"unii": ["O0P4I5851I"], "rxcui": ["1040031", "1040041", "1235247", "1297278", "1431235"], "spl_set_id": ["0f5f8228-1304-4981-8577-029136627260"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (70771-1736-1)", "package_ndc": "70771-1736-1", "marketing_start_date": "20230201"}, {"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (70771-1736-3)", "package_ndc": "70771-1736-3", "marketing_start_date": "20230201"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (70771-1736-4)  / 10 TABLET, COATED in 1 BLISTER PACK (70771-1736-2)", "package_ndc": "70771-1736-4", "marketing_start_date": "20230201"}, {"sample": false, "description": "500 TABLET, COATED in 1 BOTTLE (70771-1736-5)", "package_ndc": "70771-1736-5", "marketing_start_date": "20230201"}, {"sample": false, "description": "90 TABLET, COATED in 1 BOTTLE (70771-1736-9)", "package_ndc": "70771-1736-9", "marketing_start_date": "20230201"}], "brand_name": "Lurasidone hydrochloride", "product_id": "70771-1736_b82674a0-84e9-4431-9041-e5c360bbdaca", "dosage_form": "TABLET, COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "70771-1736", "generic_name": "Lurasidone hydrochloride", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lurasidone hydrochloride", "active_ingredients": [{"name": "LURASIDONE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA208052", "marketing_category": "ANDA", "marketing_start_date": "20230201", "listing_expiration_date": "20261231"}