lurasidone hydrochloride (62332-494)

Drug Facts

Product Profile

Brand Name lurasidone hydrochloride

Generic Name lurasidone hydrochloride

Labeler alembic pharmaceuticals inc.

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

lurasidone hydrochloride 20 mg/1

Manufacturer

Alembic Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 62332-494

Product ID 62332-494_2ad2918d-7142-4425-bd00-45a269ef0d61

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA213248

Listing Expiration 2026-12-31

Marketing Start 2023-01-24

Pharmacologic Class

Classes

atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62332494

Hyphenated Format 62332-494

Supplemental Identifiers

RxCUI

1040031 1040041 1235247 1297278 1431235

UPC

0362332496303

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 ANDA213248 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

20 mg/1

source: ndc

Packaging

100 BLISTER PACK in 1 CARTON (62332-494-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
30 TABLET, FILM COATED in 1 BOTTLE (62332-494-30)
500 TABLET, FILM COATED in 1 BOTTLE (62332-494-71)
90 TABLET, FILM COATED in 1 BOTTLE (62332-494-90)
1000 TABLET, FILM COATED in 1 BOTTLE (62332-494-91)

source: ndc

Packages (5)

62332-494-10 100 BLISTER PACK in 1 CARTON (62332-494-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK 62332-494-30 30 TABLET, FILM COATED in 1 BOTTLE (62332-494-30) 62332-494-71 500 TABLET, FILM COATED in 1 BOTTLE (62332-494-71) 62332-494-90 90 TABLET, FILM COATED in 1 BOTTLE (62332-494-90) 62332-494-91 1000 TABLET, FILM COATED in 1 BOTTLE (62332-494-91)

Ingredients (1)

lurasidone hydrochloride (20 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": "2ad2918d-7142-4425-bd00-45a269ef0d61", "openfda": {"upc": ["0362332496303"], "unii": ["O0P4I5851I"], "rxcui": ["1040031", "1040041", "1235247", "1297278", "1431235"], "spl_set_id": ["1cc441b3-0a23-4c68-a90e-436030b7daf2"], "manufacturer_name": ["Alembic Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (62332-494-10)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "62332-494-10", "marketing_start_date": "20230124"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (62332-494-30)", "package_ndc": "62332-494-30", "marketing_start_date": "20230124"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (62332-494-71)", "package_ndc": "62332-494-71", "marketing_start_date": "20230124"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (62332-494-90)", "package_ndc": "62332-494-90", "marketing_start_date": "20230124"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (62332-494-91)", "package_ndc": "62332-494-91", "marketing_start_date": "20230124"}], "brand_name": "Lurasidone Hydrochloride", "product_id": "62332-494_2ad2918d-7142-4425-bd00-45a269ef0d61", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "62332-494", "generic_name": "Lurasidone Hydrochloride", "labeler_name": "Alembic Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lurasidone Hydrochloride", "active_ingredients": [{"name": "LURASIDONE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA213248", "marketing_category": "ANDA", "marketing_start_date": "20230124", "listing_expiration_date": "20261231"}