lurasidone hydrochloride

Generic: lurasidone hydrochloride

Labeler: torrent pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lurasidone hydrochloride
Generic Name lurasidone hydrochloride
Labeler torrent pharmaceuticals limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

lurasidone hydrochloride 60 mg/1

Manufacturer
Torrent Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 13668-509
Product ID 13668-509_dba1819d-0cd5-4522-9666-5155aa9e0085
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208047
Listing Expiration 2026-12-31
Marketing Start 2023-02-17

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 13668509
Hyphenated Format 13668-509

Supplemental Identifiers

RxCUI
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 ANDA208047 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (13668-509-30)
source: ndc

Packages (1)

13668-509-30 30 TABLET, FILM COATED in 1 BOTTLE (13668-509-30)

Ingredients (1)

lurasidone hydrochloride (60 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": "dba1819d-0cd5-4522-9666-5155aa9e0085", "openfda": {"unii": ["O0P4I5851I"], "rxcui": ["1431235"], "spl_set_id": ["a101e62e-dd1f-4add-8393-ba6d54adce06"], "manufacturer_name": ["Torrent Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (13668-509-30)", "package_ndc": "13668-509-30", "marketing_start_date": "20230217"}], "brand_name": "Lurasidone hydrochloride", "product_id": "13668-509_dba1819d-0cd5-4522-9666-5155aa9e0085", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "13668-509", "generic_name": "Lurasidone hydrochloride", "labeler_name": "Torrent Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lurasidone hydrochloride", "active_ingredients": [{"name": "LURASIDONE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA208047", "marketing_category": "ANDA", "marketing_start_date": "20230217", "listing_expiration_date": "20261231"}