lurasidone hydrochloride

Generic: lurasidone hydrochloride

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

lurasidone hydrochloride 20 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-638
Product ID 67877-638_6e4065a5-2672-4ef4-996d-f9d2f58970d3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212244
Listing Expiration 2026-12-31
Marketing Start 2023-01-04

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67877638
Hyphenated Format 67877-638

Supplemental Identifiers

RxCUI
1040031 1040041 1235247 1297278 1431235
UPC
0367877639901 0367877642055 0367877640303
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 ANDA212244 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (67877-638-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (67877-638-30)
  • 10 BLISTER PACK in 1 CARTON (67877-638-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-638-33)
  • 90 TABLET, FILM COATED in 1 BOTTLE (67877-638-90)
source: ndc

Packages (4)

67877-638-05 500 TABLET, FILM COATED in 1 BOTTLE (67877-638-05) 67877-638-30 30 TABLET, FILM COATED in 1 BOTTLE (67877-638-30) 67877-638-38 10 BLISTER PACK in 1 CARTON (67877-638-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-638-33) 67877-638-90 90 TABLET, FILM COATED in 1 BOTTLE (67877-638-90)

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": "6e4065a5-2672-4ef4-996d-f9d2f58970d3", "openfda": {"upc": ["0367877639901", "0367877642055", "0367877640303"], "unii": ["O0P4I5851I"], "rxcui": ["1040031", "1040041", "1235247", "1297278", "1431235"], "spl_set_id": ["36b6bacd-ac11-493b-a8a4-8dad448ed9d5"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (67877-638-05)", "package_ndc": "67877-638-05", "marketing_start_date": "20230104"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (67877-638-30)", "package_ndc": "67877-638-30", "marketing_start_date": "20230104"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (67877-638-38)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-638-33)", "package_ndc": "67877-638-38", "marketing_start_date": "20230104"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (67877-638-90)", "package_ndc": "67877-638-90", "marketing_start_date": "20230104"}], "brand_name": "lurasidone hydrochloride", "product_id": "67877-638_6e4065a5-2672-4ef4-996d-f9d2f58970d3", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "67877-638", "generic_name": "lurasidone hydrochloride", "labeler_name": "Ascend Laboratories, LLC", "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": "20230104", "listing_expiration_date": "20261231"}