lurasidone hydrochloride

Generic: lurasidone hydrochloride

Labeler: heritage pharma labs inc. d/b/a avet pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lurasidone hydrochloride
Generic Name lurasidone hydrochloride
Labeler heritage pharma labs inc. d/b/a avet pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

lurasidone hydrochloride 120 mg/1

Manufacturer
Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 23155-891
Product ID 23155-891_0827fe43-e438-44c3-9962-7491d04b445d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208058
Listing Expiration 2026-12-31
Marketing Start 2023-10-19

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 23155891
Hyphenated Format 23155-891

Supplemental Identifiers

RxCUI
1040031 1040041 1235247 1297278 1431235
UPC
0323155888034 0323155887099 0323155891034 0323155887037 0323155890099 0323155889093 0323155888096 0323155890037 0323155889031
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 ANDA208058 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (23155-891-01)
  • 30 TABLET, FILM COATED in 1 BOTTLE (23155-891-03)
  • 500 TABLET, FILM COATED in 1 BOTTLE (23155-891-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (23155-891-10)
  • 20000 TABLET, FILM COATED in 1 CONTAINER (23155-891-18)
source: ndc

Packages (5)

23155-891-01 100 TABLET, FILM COATED in 1 BOTTLE (23155-891-01) 23155-891-03 30 TABLET, FILM COATED in 1 BOTTLE (23155-891-03) 23155-891-05 500 TABLET, FILM COATED in 1 BOTTLE (23155-891-05) 23155-891-10 1000 TABLET, FILM COATED in 1 BOTTLE (23155-891-10) 23155-891-18 20000 TABLET, FILM COATED in 1 CONTAINER (23155-891-18)

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": "0827fe43-e438-44c3-9962-7491d04b445d", "openfda": {"upc": ["0323155888034", "0323155887099", "0323155891034", "0323155887037", "0323155890099", "0323155889093", "0323155888096", "0323155890037", "0323155889031"], "unii": ["O0P4I5851I"], "rxcui": ["1040031", "1040041", "1235247", "1297278", "1431235"], "spl_set_id": ["083a1a52-5a13-4e28-8ef2-127ac4ce5b2d"], "manufacturer_name": ["Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (23155-891-01)", "package_ndc": "23155-891-01", "marketing_start_date": "20250820"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (23155-891-03)", "package_ndc": "23155-891-03", "marketing_start_date": "20250820"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (23155-891-05)", "package_ndc": "23155-891-05", "marketing_start_date": "20250820"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (23155-891-10)", "package_ndc": "23155-891-10", "marketing_start_date": "20250820"}, {"sample": false, "description": "20000 TABLET, FILM COATED in 1 CONTAINER (23155-891-18)", "package_ndc": "23155-891-18", "marketing_start_date": "20231019"}], "brand_name": "Lurasidone Hydrochloride", "product_id": "23155-891_0827fe43-e438-44c3-9962-7491d04b445d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "23155-891", "generic_name": "Lurasidone Hydrochloride", "labeler_name": "Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lurasidone Hydrochloride", "active_ingredients": [{"name": "LURASIDONE HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA208058", "marketing_category": "ANDA", "marketing_start_date": "20231019", "listing_expiration_date": "20261231"}