lurasidone hydrochloride

Generic: lurasidone hydrochloride

Labeler: camber pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lurasidone hydrochloride
Generic Name lurasidone hydrochloride
Labeler camber pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

lurasidone hydrochloride 120 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-084
Product ID 31722-084_3a429e3e-35e3-c6bb-e063-6294a90ac9ee
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218174
Listing Expiration 2026-12-31
Marketing Start 2024-08-21

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 31722084
Hyphenated Format 31722-084

Supplemental Identifiers

RxCUI
1040031 1040041 1235247 1297278 1431235
UPC
0331722083300
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 ANDA218174 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (31722-084-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (31722-084-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (31722-084-90)
source: ndc

Packages (3)

31722-084-05 500 TABLET, FILM COATED in 1 BOTTLE (31722-084-05) 31722-084-30 30 TABLET, FILM COATED in 1 BOTTLE (31722-084-30) 31722-084-90 90 TABLET, FILM COATED in 1 BOTTLE (31722-084-90)

Ingredients (1)

lurasidone hydrochloride (120 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": "3a429e3e-35e3-c6bb-e063-6294a90ac9ee", "openfda": {"upc": ["0331722083300"], "unii": ["O0P4I5851I"], "rxcui": ["1040031", "1040041", "1235247", "1297278", "1431235"], "spl_set_id": ["c80625bb-7857-4763-81fe-542b3448d84f"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (31722-084-05)", "package_ndc": "31722-084-05", "marketing_start_date": "20240821"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (31722-084-30)", "package_ndc": "31722-084-30", "marketing_start_date": "20240821"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (31722-084-90)", "package_ndc": "31722-084-90", "marketing_start_date": "20240821"}], "brand_name": "Lurasidone Hydrochloride", "product_id": "31722-084_3a429e3e-35e3-c6bb-e063-6294a90ac9ee", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "31722-084", "generic_name": "Lurasidone Hydrochloride", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lurasidone Hydrochloride", "active_ingredients": [{"name": "LURASIDONE HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA218174", "marketing_category": "ANDA", "marketing_start_date": "20240821", "listing_expiration_date": "20261231"}