lurasidone hydrochloride

Generic: lurasidone hydrochloride

Labeler: northstar rxllc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lurasidone hydrochloride
Generic Name lurasidone hydrochloride
Labeler northstar rxllc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

lurasidone hydrochloride 80 mg/1

Manufacturer
NorthStar RxLLC

Identifiers & Regulatory

Product NDC 72603-624
Product ID 72603-624_10a88607-0b5e-4707-b0cb-40c58a5c6774
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212124
Listing Expiration 2026-12-31
Marketing Start 2025-04-08

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72603624
Hyphenated Format 72603-624

Supplemental Identifiers

RxCUI
1040031 1040041 1235247 1431235
UPC
0372603621013 0372603622010 0372603623017 0372603624014
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 ANDA212124 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (72603-624-01)
source: ndc

Packages (1)

72603-624-01 30 TABLET, FILM COATED in 1 BOTTLE (72603-624-01)

Ingredients (1)

lurasidone hydrochloride (80 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": "10a88607-0b5e-4707-b0cb-40c58a5c6774", "openfda": {"upc": ["0372603621013", "0372603622010", "0372603623017", "0372603624014"], "unii": ["O0P4I5851I"], "rxcui": ["1040031", "1040041", "1235247", "1431235"], "spl_set_id": ["10a88607-0b5e-4707-b0cb-40c58a5c6774"], "manufacturer_name": ["NorthStar RxLLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (72603-624-01)", "package_ndc": "72603-624-01", "marketing_start_date": "20250408"}], "brand_name": "lurasidone hydrochloride", "product_id": "72603-624_10a88607-0b5e-4707-b0cb-40c58a5c6774", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "72603-624", "generic_name": "lurasidone hydrochloride", "labeler_name": "NorthStar RxLLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "lurasidone hydrochloride", "active_ingredients": [{"name": "LURASIDONE HYDROCHLORIDE", "strength": "80 mg/1"}], "application_number": "ANDA212124", "marketing_category": "ANDA", "marketing_start_date": "20250408", "listing_expiration_date": "20261231"}