lurasidone hydrochloride

Generic: lurasidone hydrochloride

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

Drug Facts

Product Profile

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

lurasidone hydrochloride 80 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-673
Product ID 68180-673_8d77b0dd-8cc2-44da-afed-1e5cb75bed99
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208031
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 68180673
Hyphenated Format 68180-673

Supplemental Identifiers

RxCUI
1040031 1040041 1235247 1297278 1431235
UPC
0368180671060 0368180673064 0368180672067 0368180670063 0368180674061
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 ANDA208031 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (68180-673-06)
source: ndc

Packages (1)

68180-673-06 30 TABLET in 1 BOTTLE (68180-673-06)

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": "8d77b0dd-8cc2-44da-afed-1e5cb75bed99", "openfda": {"upc": ["0368180671060", "0368180673064", "0368180672067", "0368180670063", "0368180674061"], "unii": ["O0P4I5851I"], "rxcui": ["1040031", "1040041", "1235247", "1297278", "1431235"], "spl_set_id": ["74f2429b-71df-47f0-9cb5-98685372a9b8"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (68180-673-06)", "package_ndc": "68180-673-06", "marketing_start_date": "20230220"}], "brand_name": "lurasidone hydrochloride", "product_id": "68180-673_8d77b0dd-8cc2-44da-afed-1e5cb75bed99", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "68180-673", "generic_name": "lurasidone hydrochloride", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "lurasidone hydrochloride", "active_ingredients": [{"name": "LURASIDONE HYDROCHLORIDE", "strength": "80 mg/1"}], "application_number": "ANDA208031", "marketing_category": "ANDA", "marketing_start_date": "20230220", "listing_expiration_date": "20261231"}