lurasidone hydrochloride

Product NDC
50090-6438
11-digit product format
500906438
Labeler code
50090
Product ID
50090-6438_6bf72f5b-ee22-47bb-a052-2bf67dde23a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lurasidone hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA208049
Marketing category
ANDA
Marketing start
2023-02-20
Substance
LURASIDONE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
O0P4I5851ILURASIDONE HYDROCHLORIDE367514-88-3LURASIDONE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6438-05009064380030 TABLET, FILM COATED in 1 BOTTLE (50090-6438-0) 2023-04-17NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
lurasidone hydrochlorideA-S Medication Solutions2023-04-26HUMAN PRESCRIPTION DRUG LABEL1