lurasidone hydrochloride

Generic: lurasidone hydrochloride

Labeler: dr. reddys laboratories inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lurasidone hydrochloride
Generic Name lurasidone hydrochloride
Labeler dr. reddys laboratories inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

lurasidone hydrochloride 120 mg/1

Manufacturer
Dr. Reddys Laboratories Inc

Identifiers & Regulatory

Product NDC 43598-355
Product ID 43598-355_a6742369-fc8f-d7cc-42c1-33c95d6946ef
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208055
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 43598355
Hyphenated Format 43598-355

Supplemental Identifiers

RxCUI
1297278
UPC
0343598355306
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 ANDA208055 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (43598-355-30)
source: ndc

Packages (1)

43598-355-30 30 TABLET, FILM COATED in 1 BOTTLE (43598-355-30)

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": "a6742369-fc8f-d7cc-42c1-33c95d6946ef", "openfda": {"upc": ["0343598355306"], "unii": ["O0P4I5851I"], "rxcui": ["1297278"], "spl_set_id": ["2f22a0bd-94f3-53d7-717c-03da8e1a7e97"], "manufacturer_name": ["Dr. Reddys Laboratories Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (43598-355-30)", "package_ndc": "43598-355-30", "marketing_start_date": "20230220"}], "brand_name": "Lurasidone Hydrochloride", "product_id": "43598-355_a6742369-fc8f-d7cc-42c1-33c95d6946ef", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "43598-355", "generic_name": "Lurasidone Hydrochloride", "labeler_name": "Dr. Reddys Laboratories Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lurasidone Hydrochloride", "active_ingredients": [{"name": "LURASIDONE HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA208055", "marketing_category": "ANDA", "marketing_start_date": "20230220", "listing_expiration_date": "20261231"}