lurasidone hydrochloride

Generic: lurasidone hydrochloride

Labeler: novadoz pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lurasidone hydrochloride
Generic Name lurasidone hydrochloride
Labeler novadoz pharmaceuticals llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

lurasidone hydrochloride 80 mg/1

Manufacturer
Novadoz Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 72205-210
Product ID 72205-210_8f42d8c8-cccf-49e3-9bad-e9a45d8d7896
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208037
Listing Expiration 2026-12-31
Marketing Start 2023-02-09

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72205210
Hyphenated Format 72205-210

Supplemental Identifiers

RxCUI
1040031 1040041 1235247 1297278 1431235
UPC
0372205208308 0372205209053 0372205209909 0372205210905 0372205209305 0372205210301 0372205211902 0372205207059 0372205211308 0372205210059 0372205211056 0372205208056 0372205207301 0372205208902 0372205207905
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 ANDA208037 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (72205-210-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (72205-210-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (72205-210-90)
source: ndc

Packages (3)

72205-210-05 500 TABLET, FILM COATED in 1 BOTTLE (72205-210-05) 72205-210-30 30 TABLET, FILM COATED in 1 BOTTLE (72205-210-30) 72205-210-90 90 TABLET, FILM COATED in 1 BOTTLE (72205-210-90)

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": "8f42d8c8-cccf-49e3-9bad-e9a45d8d7896", "openfda": {"upc": ["0372205208308", "0372205209053", "0372205209909", "0372205210905", "0372205209305", "0372205210301", "0372205211902", "0372205207059", "0372205211308", "0372205210059", "0372205211056", "0372205208056", "0372205207301", "0372205208902", "0372205207905"], "unii": ["O0P4I5851I"], "rxcui": ["1040031", "1040041", "1235247", "1297278", "1431235"], "spl_set_id": ["4f969224-a9f0-4089-84d6-a15664ea7bfe"], "manufacturer_name": ["Novadoz Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (72205-210-05)", "package_ndc": "72205-210-05", "marketing_start_date": "20230220"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (72205-210-30)", "package_ndc": "72205-210-30", "marketing_start_date": "20230220"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (72205-210-90)", "package_ndc": "72205-210-90", "marketing_start_date": "20230220"}], "brand_name": "lurasidone hydrochloride", "product_id": "72205-210_8f42d8c8-cccf-49e3-9bad-e9a45d8d7896", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "72205-210", "generic_name": "lurasidone hydrochloride", "labeler_name": "Novadoz Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "lurasidone hydrochloride", "active_ingredients": [{"name": "LURASIDONE HYDROCHLORIDE", "strength": "80 mg/1"}], "application_number": "ANDA208037", "marketing_category": "ANDA", "marketing_start_date": "20230209", "listing_expiration_date": "20261231"}