lurasidone hydrochloride

Generic: lurasidone hydrochloride

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lurasidone hydrochloride
Generic Name lurasidone hydrochloride
Labeler american health packaging
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

lurasidone hydrochloride 20 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-747
Product ID 60687-747_2abe376d-e980-af98-e063-6394a90ac3ef
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212244
Listing Expiration 2026-12-31
Marketing Start 2023-06-05

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60687747
Hyphenated Format 60687-747

Supplemental Identifiers

RxCUI
1040031 1040041 1235247 1431235
UNII
O0P4I5851I

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 ANDA212244 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 CARTON (60687-747-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-747-11)
source: ndc

Packages (1)

60687-747-21 30 BLISTER PACK in 1 CARTON (60687-747-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-747-11)

Ingredients (1)

lurasidone hydrochloride (20 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": "2abe376d-e980-af98-e063-6394a90ac3ef", "openfda": {"unii": ["O0P4I5851I"], "rxcui": ["1040031", "1040041", "1235247", "1431235"], "spl_set_id": ["b83e1015-8016-4c7c-8239-8dba3a882e46"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (60687-747-21)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-747-11)", "package_ndc": "60687-747-21", "marketing_start_date": "20230605"}], "brand_name": "Lurasidone Hydrochloride", "product_id": "60687-747_2abe376d-e980-af98-e063-6394a90ac3ef", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "60687-747", "generic_name": "Lurasidone Hydrochloride", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lurasidone Hydrochloride", "active_ingredients": [{"name": "LURASIDONE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA212244", "marketing_category": "ANDA", "marketing_start_date": "20230605", "listing_expiration_date": "20261231"}