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
Routes
ORAL
Active Ingredients

lurasidone hydrochloride 20 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-215
Product ID 82804-215_fa9f0d28-c525-4a1e-acec-84c82e10b9a2
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 82804215
Hyphenated Format 82804-215

Supplemental Identifiers

RxCUI
1235247
UPC
0382804215300
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 ANDA208045 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (82804-215-30)
source: ndc

Packages (1)

82804-215-30 30 TABLET in 1 BOTTLE (82804-215-30)

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": "fa9f0d28-c525-4a1e-acec-84c82e10b9a2", "openfda": {"upc": ["0382804215300"], "unii": ["O0P4I5851I"], "rxcui": ["1235247"], "spl_set_id": ["fa9f0d28-c525-4a1e-acec-84c82e10b9a2"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (82804-215-30)", "package_ndc": "82804-215-30", "marketing_start_date": "20250331"}], "brand_name": "LURASIDONE HYDROCHLORIDE", "product_id": "82804-215_fa9f0d28-c525-4a1e-acec-84c82e10b9a2", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "82804-215", "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": "ANDA208045", "marketing_category": "ANDA", "marketing_start_date": "20230310", "listing_expiration_date": "20261231"}