lurasidone hydrochloride

Generic: lurasidone hydrochloride

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

lurasidone hydrochloride 80 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-881
Product ID 65162-881_cfb63983-dd01-4006-b387-7e8cfec0699d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208002
Listing Expiration 2026-12-31
Marketing Start 2023-01-02

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162881
Hyphenated Format 65162-881

Supplemental Identifiers

RxCUI
1040031 1040041 1235247 1297278 1431235
UPC
0365162882032 0365162880038 0365162879032 0365162082036 0365162881035
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 ANDA208002 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 30 TABLET, COATED in 1 BOTTLE (65162-881-03)
  • 90 TABLET, COATED in 1 BOTTLE (65162-881-09)
  • 500 TABLET, COATED in 1 BOTTLE (65162-881-50)
source: ndc

Packages (3)

65162-881-03 30 TABLET, COATED in 1 BOTTLE (65162-881-03) 65162-881-09 90 TABLET, COATED in 1 BOTTLE (65162-881-09) 65162-881-50 500 TABLET, COATED in 1 BOTTLE (65162-881-50)

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": "cfb63983-dd01-4006-b387-7e8cfec0699d", "openfda": {"upc": ["0365162882032", "0365162880038", "0365162879032", "0365162082036", "0365162881035"], "unii": ["O0P4I5851I"], "rxcui": ["1040031", "1040041", "1235247", "1297278", "1431235"], "spl_set_id": ["6ef0b2f9-9356-4f61-a2fa-e7c2c77a5d3a"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (65162-881-03)", "package_ndc": "65162-881-03", "marketing_start_date": "20230102"}, {"sample": false, "description": "90 TABLET, COATED in 1 BOTTLE (65162-881-09)", "package_ndc": "65162-881-09", "marketing_start_date": "20230102"}, {"sample": false, "description": "500 TABLET, COATED in 1 BOTTLE (65162-881-50)", "package_ndc": "65162-881-50", "marketing_start_date": "20230102"}], "brand_name": "Lurasidone Hydrochloride", "product_id": "65162-881_cfb63983-dd01-4006-b387-7e8cfec0699d", "dosage_form": "TABLET, COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "65162-881", "generic_name": "Lurasidone Hydrochloride", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lurasidone Hydrochloride", "active_ingredients": [{"name": "LURASIDONE HYDROCHLORIDE", "strength": "80 mg/1"}], "application_number": "ANDA208002", "marketing_category": "ANDA", "marketing_start_date": "20230102", "listing_expiration_date": "20261231"}