lurasidone hydrochloride

Generic: lurasidone hydrochloride

Labeler: accord healthcare, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lurasidone hydrochloride
Generic Name lurasidone hydrochloride
Labeler accord healthcare, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

lurasidone hydrochloride 120 mg/1

Manufacturer
Accord Healthcare, Inc.

Identifiers & Regulatory

Product NDC 16729-350
Product ID 16729-350_415fe396-0d31-40a9-e063-6294a90a8462
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208049
Listing Expiration 2026-12-31
Marketing Start 2023-02-20

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16729350
Hyphenated Format 16729-350

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 ANDA208049 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (16729-350-10)
source: ndc

Packages (1)

16729-350-10 30 TABLET, FILM COATED in 1 BOTTLE (16729-350-10)

Ingredients (1)

lurasidone hydrochloride (120 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": "415fe396-0d31-40a9-e063-6294a90a8462", "openfda": {"unii": ["O0P4I5851I"], "rxcui": ["1040031", "1040041", "1235247", "1297278", "1431235"], "spl_set_id": ["7e11ec22-63c1-41a6-899c-4fe746f76bd0"], "manufacturer_name": ["Accord Healthcare, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (16729-350-10)", "package_ndc": "16729-350-10", "marketing_start_date": "20230220"}], "brand_name": "lurasidone hydrochloride", "product_id": "16729-350_415fe396-0d31-40a9-e063-6294a90a8462", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "16729-350", "generic_name": "lurasidone hydrochloride", "labeler_name": "Accord Healthcare, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "lurasidone hydrochloride", "active_ingredients": [{"name": "LURASIDONE HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA208049", "marketing_category": "ANDA", "marketing_start_date": "20230220", "listing_expiration_date": "20261231"}