lurasidone hydrochloride (46708-495)

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 40 mg/1

Manufacturer

Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-495

Product ID 46708-495_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 46708495

Hyphenated Format 46708-495

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

40 mg/1

source: ndc

Packaging

100 BLISTER PACK in 1 CARTON (46708-495-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
30 TABLET, FILM COATED in 1 BOTTLE (46708-495-30)
500 TABLET, FILM COATED in 1 BOTTLE (46708-495-71)
90 TABLET, FILM COATED in 1 BOTTLE (46708-495-90)
1000 TABLET, FILM COATED in 1 BOTTLE (46708-495-91)

source: ndc

Packages (5)

46708-495-10 100 BLISTER PACK in 1 CARTON (46708-495-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK 46708-495-30 30 TABLET, FILM COATED in 1 BOTTLE (46708-495-30) 46708-495-71 500 TABLET, FILM COATED in 1 BOTTLE (46708-495-71) 46708-495-90 90 TABLET, FILM COATED in 1 BOTTLE (46708-495-90) 46708-495-91 1000 TABLET, FILM COATED in 1 BOTTLE (46708-495-91)

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

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