lurasidone hydrochloride

Generic: lurasidone hydrochloride

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lurasidone hydrochloride
Generic Name lurasidone hydrochloride
Labeler proficient rx lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

lurasidone hydrochloride 20 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-034
Product ID 82804-034_5c5f8dc7-3941-42be-8e7f-3c5027ac570e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212091
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 82804034
Hyphenated Format 82804-034

Supplemental Identifiers

RxCUI
1235247
UPC
0382804034307
UNII
O0P4I5851I

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 ANDA212091 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (82804-034-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (82804-034-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (82804-034-90)
source: ndc

Packages (3)

82804-034-30 30 TABLET, FILM COATED in 1 BOTTLE (82804-034-30) 82804-034-60 60 TABLET, FILM COATED in 1 BOTTLE (82804-034-60) 82804-034-90 90 TABLET, FILM COATED in 1 BOTTLE (82804-034-90)

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": "5c5f8dc7-3941-42be-8e7f-3c5027ac570e", "openfda": {"upc": ["0382804034307"], "unii": ["O0P4I5851I"], "rxcui": ["1235247"], "spl_set_id": ["5c5f8dc7-3941-42be-8e7f-3c5027ac570e"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (82804-034-30)", "package_ndc": "82804-034-30", "marketing_start_date": "20231101"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (82804-034-60)", "package_ndc": "82804-034-60", "marketing_start_date": "20231101"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (82804-034-90)", "package_ndc": "82804-034-90", "marketing_start_date": "20231101"}], "brand_name": "lurasidone hydrochloride", "product_id": "82804-034_5c5f8dc7-3941-42be-8e7f-3c5027ac570e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "82804-034", "generic_name": "lurasidone hydrochloride", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "lurasidone hydrochloride", "active_ingredients": [{"name": "LURASIDONE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA212091", "marketing_category": "ANDA", "marketing_start_date": "20230220", "listing_expiration_date": "20261231"}