latuda

Generic: lurasidone hydrochloride

Labeler: sumitomo pharma america, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name latuda
Generic Name lurasidone hydrochloride
Labeler sumitomo pharma america, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

lurasidone hydrochloride 120 mg/1

Manufacturer
Sumitomo Pharma America, Inc.

Identifiers & Regulatory

Product NDC 63402-312
Product ID 63402-312_7383b0e0-01e8-4778-96f0-6f2e0c9586ae
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA200603
Listing Expiration 2027-12-31
Marketing Start 2012-04-26

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63402312
Hyphenated Format 63402-312

Supplemental Identifiers

RxCUI
1040031 1040036 1040041 1040043 1235247 1235249 1297278 1297357 1431235 1431237
UPC
0363402306300 0363402302302 0363402304306 0363402312301 0363402306102 0363402306508 0363402308304 0363402306904
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 latuda (source: ndc)
Generic Name lurasidone hydrochloride (source: ndc)
Application Number NDA200603 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 4 BLISTER PACK in 1 CARTON (63402-312-04) / 7 TABLET, FILM COATED in 1 BLISTER PACK (63402-312-07)
  • 10 BLISTER PACK in 1 CARTON (63402-312-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK (63402-312-01)
  • 30 TABLET, FILM COATED in 1 BOTTLE (63402-312-30)
  • 500 TABLET, FILM COATED in 1 BOTTLE (63402-312-50)
  • 90 TABLET, FILM COATED in 1 BOTTLE (63402-312-90)
source: ndc

Packages (5)

63402-312-04 4 BLISTER PACK in 1 CARTON (63402-312-04) / 7 TABLET, FILM COATED in 1 BLISTER PACK (63402-312-07) 63402-312-10 10 BLISTER PACK in 1 CARTON (63402-312-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK (63402-312-01) 63402-312-30 30 TABLET, FILM COATED in 1 BOTTLE (63402-312-30) 63402-312-50 500 TABLET, FILM COATED in 1 BOTTLE (63402-312-50) 63402-312-90 90 TABLET, FILM COATED in 1 BOTTLE (63402-312-90)

Ingredients (1)

lurasidone hydrochloride (120 mg/1)

Linked Drug Pages (1)

Latuda ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7383b0e0-01e8-4778-96f0-6f2e0c9586ae", "openfda": {"upc": ["0363402306300", "0363402302302", "0363402304306", "0363402312301", "0363402306102", "0363402306508", "0363402308304", "0363402306904"], "unii": ["O0P4I5851I"], "rxcui": ["1040031", "1040036", "1040041", "1040043", "1235247", "1235249", "1297278", "1297357", "1431235", "1431237"], "spl_set_id": ["afad3051-9df2-4c54-9684-e8262a133af8"], "manufacturer_name": ["Sumitomo Pharma America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 BLISTER PACK in 1 CARTON (63402-312-04)  / 7 TABLET, FILM COATED in 1 BLISTER PACK (63402-312-07)", "package_ndc": "63402-312-04", "marketing_start_date": "20120426"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (63402-312-10)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (63402-312-01)", "package_ndc": "63402-312-10", "marketing_start_date": "20120426"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (63402-312-30)", "package_ndc": "63402-312-30", "marketing_start_date": "20120426"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (63402-312-50)", "package_ndc": "63402-312-50", "marketing_start_date": "20120426"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (63402-312-90)", "package_ndc": "63402-312-90", "marketing_start_date": "20120426"}], "brand_name": "Latuda", "product_id": "63402-312_7383b0e0-01e8-4778-96f0-6f2e0c9586ae", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "63402-312", "generic_name": "lurasidone hydrochloride", "labeler_name": "Sumitomo Pharma America, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Latuda", "active_ingredients": [{"name": "LURASIDONE HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "NDA200603", "marketing_category": "NDA", "marketing_start_date": "20120426", "listing_expiration_date": "20271231"}