lurasidone hydrochloride

Generic: lurasidone hydrochloride

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lurasidone hydrochloride
Generic Name lurasidone hydrochloride
Labeler a-s medication solutions
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

lurasidone hydrochloride 20 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-7078
Product ID 50090-7078_4f7ceeb8-872a-4e89-b8bd-e198d939acf0
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 500907078
Hyphenated Format 50090-7078

Supplemental Identifiers

RxCUI
1235247
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 (50090-7078-0)
source: ndc

Packages (1)

50090-7078-0 30 TABLET, FILM COATED in 1 BOTTLE (50090-7078-0)

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": "4f7ceeb8-872a-4e89-b8bd-e198d939acf0", "openfda": {"unii": ["O0P4I5851I"], "rxcui": ["1235247"], "spl_set_id": ["b848e6f3-63c0-4d2e-bda5-c9e961472092"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (50090-7078-0)", "package_ndc": "50090-7078-0", "marketing_start_date": "20240131"}], "brand_name": "lurasidone hydrochloride", "product_id": "50090-7078_4f7ceeb8-872a-4e89-b8bd-e198d939acf0", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "50090-7078", "generic_name": "lurasidone hydrochloride", "labeler_name": "A-S Medication Solutions", "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"}