lurasidone hydrochloride

Generic: lurasidone hydrochloride

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lurasidone hydrochloride
Generic Name lurasidone hydrochloride
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

lurasidone hydrochloride 20 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-953
Product ID 65862-953_b73e1972-e96d-4463-ad39-f7bed99466e9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208045
Listing Expiration 2026-12-31
Marketing Start 2023-03-10

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862953
Hyphenated Format 65862-953

Supplemental Identifiers

RxCUI
1040031 1040041 1235247 1297278 1431235
UPC
0365862955302 0365862956309
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 ANDA208045 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (65862-953-05)
  • 30 TABLET in 1 BOTTLE (65862-953-30)
  • 90 TABLET in 1 BOTTLE (65862-953-90)
source: ndc

Packages (3)

65862-953-05 500 TABLET in 1 BOTTLE (65862-953-05) 65862-953-30 30 TABLET in 1 BOTTLE (65862-953-30) 65862-953-90 90 TABLET in 1 BOTTLE (65862-953-90)

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": "b73e1972-e96d-4463-ad39-f7bed99466e9", "openfda": {"upc": ["0365862955302", "0365862956309"], "unii": ["O0P4I5851I"], "rxcui": ["1040031", "1040041", "1235247", "1297278", "1431235"], "spl_set_id": ["b3e9cc86-0c5c-444f-ab57-f4d1a6865035"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (65862-953-05)", "package_ndc": "65862-953-05", "marketing_start_date": "20230310"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (65862-953-30)", "package_ndc": "65862-953-30", "marketing_start_date": "20230310"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (65862-953-90)", "package_ndc": "65862-953-90", "marketing_start_date": "20230310"}], "brand_name": "LURASIDONE HYDROCHLORIDE", "product_id": "65862-953_b73e1972-e96d-4463-ad39-f7bed99466e9", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "65862-953", "generic_name": "LURASIDONE HYDROCHLORIDE", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LURASIDONE HYDROCHLORIDE", "active_ingredients": [{"name": "LURASIDONE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA208045", "marketing_category": "ANDA", "marketing_start_date": "20230310", "listing_expiration_date": "20261231"}