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 20 mg/1

Manufacturer
Dr. Reddys Laboratories Inc

Identifiers & Regulatory

Product NDC 43598-351
Product ID 43598-351_f3c17d88-383d-89de-d8d6-8ed1bb1b3750
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208047
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 43598351
Hyphenated Format 43598-351

Supplemental Identifiers

RxCUI
1040031 1040041 1235247 1431235
UPC
0343598353302 0343598354309 0343598351308 0343598352305
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
  • 20 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (43598-351-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (43598-351-30)
  • 10 BLISTER PACK in 1 CARTON (43598-351-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (43598-351-79)
  • 90 TABLET, FILM COATED in 1 BOTTLE (43598-351-90)
source: ndc

Packages (4)

43598-351-05 500 TABLET, FILM COATED in 1 BOTTLE (43598-351-05) 43598-351-30 30 TABLET, FILM COATED in 1 BOTTLE (43598-351-30) 43598-351-78 10 BLISTER PACK in 1 CARTON (43598-351-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (43598-351-79) 43598-351-90 90 TABLET, FILM COATED in 1 BOTTLE (43598-351-90)

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": "f3c17d88-383d-89de-d8d6-8ed1bb1b3750", "openfda": {"upc": ["0343598353302", "0343598354309", "0343598351308", "0343598352305"], "unii": ["O0P4I5851I"], "rxcui": ["1040031", "1040041", "1235247", "1431235"], "spl_set_id": ["9b512af1-98ab-1242-10e8-9534a002306e"], "manufacturer_name": ["Dr. Reddys Laboratories Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (43598-351-05)", "package_ndc": "43598-351-05", "marketing_start_date": "20230220"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (43598-351-30)", "package_ndc": "43598-351-30", "marketing_start_date": "20230220"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (43598-351-78)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (43598-351-79)", "package_ndc": "43598-351-78", "marketing_start_date": "20230220"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (43598-351-90)", "package_ndc": "43598-351-90", "marketing_start_date": "20230220"}], "brand_name": "Lurasidone hydrochloride", "product_id": "43598-351_f3c17d88-383d-89de-d8d6-8ed1bb1b3750", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "43598-351", "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": "20 mg/1"}], "application_number": "ANDA208047", "marketing_category": "ANDA", "marketing_start_date": "20230220", "listing_expiration_date": "20261231"}