lurasidone hydrochloride

Generic: lurasidone hydrochloride

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

Drug Facts

Product Profile

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

lurasidone hydrochloride 40 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 53746-880
Product ID 53746-880_f81d4ba1-6578-46ad-bbc6-7c80a6e37625
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208002
Listing Expiration 2026-12-31
Marketing Start 2024-07-05

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53746880
Hyphenated Format 53746-880

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 ANDA208002 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 TABLET, COATED in 1 BOTTLE (53746-880-30)
source: ndc

Packages (1)

53746-880-30 30 TABLET, COATED in 1 BOTTLE (53746-880-30)

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": "f81d4ba1-6578-46ad-bbc6-7c80a6e37625", "openfda": {"unii": ["O0P4I5851I"], "rxcui": ["1040031", "1040041", "1235247", "1297278", "1431235"], "spl_set_id": ["84648adf-b3c6-476e-8d11-2a9d7c5eb550"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (53746-880-30)", "package_ndc": "53746-880-30", "marketing_start_date": "20240705"}], "brand_name": "Lurasidone Hydrochloride", "product_id": "53746-880_f81d4ba1-6578-46ad-bbc6-7c80a6e37625", "dosage_form": "TABLET, COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "53746-880", "generic_name": "Lurasidone Hydrochloride", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lurasidone Hydrochloride", "active_ingredients": [{"name": "LURASIDONE HYDROCHLORIDE", "strength": "40 mg/1"}], "application_number": "ANDA208002", "marketing_category": "ANDA", "marketing_start_date": "20240705", "listing_expiration_date": "20261231"}