lurasidone hydrochloride (46708-497)

Drug Facts

Product Profile

Brand Name lurasidone hydrochloride

Generic Name lurasidone hydrochloride

Labeler alembic pharmaceuticals limited

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

lurasidone hydrochloride 80 mg/1

Manufacturer

Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-497

Product ID 46708-497_a4f0715d-590f-4b13-bb72-19cdca95aa01

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 46708497

Hyphenated Format 46708-497

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 ANDA213248 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

80 mg/1

source: ndc

Packaging

100 BLISTER PACK in 1 CARTON (46708-497-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
30 TABLET, FILM COATED in 1 BOTTLE (46708-497-30)
500 TABLET, FILM COATED in 1 BOTTLE (46708-497-71)
90 TABLET, FILM COATED in 1 BOTTLE (46708-497-90)
1000 TABLET, FILM COATED in 1 BOTTLE (46708-497-91)

source: ndc

Packages (5)

46708-497-10 100 BLISTER PACK in 1 CARTON (46708-497-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK 46708-497-30 30 TABLET, FILM COATED in 1 BOTTLE (46708-497-30) 46708-497-71 500 TABLET, FILM COATED in 1 BOTTLE (46708-497-71) 46708-497-90 90 TABLET, FILM COATED in 1 BOTTLE (46708-497-90) 46708-497-91 1000 TABLET, FILM COATED in 1 BOTTLE (46708-497-91)

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": "a4f0715d-590f-4b13-bb72-19cdca95aa01", "openfda": {"unii": ["O0P4I5851I"], "rxcui": ["1040031", "1040041", "1235247", "1297278", "1431235"], "spl_set_id": ["27f70e15-ee22-47ae-ba87-20e2b4a1a4d6"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (46708-497-10)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "46708-497-10", "marketing_start_date": "20230124"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (46708-497-30)", "package_ndc": "46708-497-30", "marketing_start_date": "20230124"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (46708-497-71)", "package_ndc": "46708-497-71", "marketing_start_date": "20230124"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (46708-497-90)", "package_ndc": "46708-497-90", "marketing_start_date": "20230124"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (46708-497-91)", "package_ndc": "46708-497-91", "marketing_start_date": "20230124"}], "brand_name": "Lurasidone Hydrochloride", "product_id": "46708-497_a4f0715d-590f-4b13-bb72-19cdca95aa01", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "46708-497", "generic_name": "Lurasidone Hydrochloride", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lurasidone Hydrochloride", "active_ingredients": [{"name": "LURASIDONE HYDROCHLORIDE", "strength": "80 mg/1"}], "application_number": "ANDA213248", "marketing_category": "ANDA", "marketing_start_date": "20230124", "listing_expiration_date": "20261231"}