lurasidone hydrochloride

Generic: lurasidone hydrochloride

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lurasidone hydrochloride
Generic Name lurasidone hydrochloride
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

lurasidone hydrochloride 80 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-685
Product ID 47335-685_2ebf334e-6f66-4ef7-b0ca-9d21ccb3165e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208066
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 47335685
Hyphenated Format 47335-685

Supplemental Identifiers

RxCUI
1040031 1040041 1235247 1297278 1431235
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 ANDA208066 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (47335-685-13)
  • 90 TABLET in 1 BOTTLE (47335-685-81)
  • 30 TABLET in 1 BOTTLE (47335-685-83)
source: ndc

Packages (3)

47335-685-13 500 TABLET in 1 BOTTLE (47335-685-13) 47335-685-81 90 TABLET in 1 BOTTLE (47335-685-81) 47335-685-83 30 TABLET in 1 BOTTLE (47335-685-83)

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": "2ebf334e-6f66-4ef7-b0ca-9d21ccb3165e", "openfda": {"unii": ["O0P4I5851I"], "rxcui": ["1040031", "1040041", "1235247", "1297278", "1431235"], "spl_set_id": ["6d97d871-66d3-4ed8-bbc5-0620e9f69ae5"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (47335-685-13)", "package_ndc": "47335-685-13", "marketing_start_date": "20230220"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (47335-685-81)", "package_ndc": "47335-685-81", "marketing_start_date": "20230220"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (47335-685-83)", "package_ndc": "47335-685-83", "marketing_start_date": "20230220"}], "brand_name": "Lurasidone Hydrochloride", "product_id": "47335-685_2ebf334e-6f66-4ef7-b0ca-9d21ccb3165e", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "47335-685", "generic_name": "Lurasidone Hydrochloride", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lurasidone Hydrochloride", "active_ingredients": [{"name": "LURASIDONE HYDROCHLORIDE", "strength": "80 mg/1"}], "application_number": "ANDA208066", "marketing_category": "ANDA", "marketing_start_date": "20230220", "listing_expiration_date": "20261231"}