Lurasidone HCL

Product NDC
72189-598
11-digit product format
721890598
Labeler code
72189
Product ID
72189-598_296811cf-cba9-16c2-e063-6294a90acfa6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lurasidone HCL
Dosage form
TABLET
Route
ORAL
Labeler
Direct_rx
Application
ANDA208045
Marketing category
ANDA
Marketing start
2024-12-16
Substance
LURASIDONE HYDROCHLORIDE
Active strength
40 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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
72189-598-307218905983030 TABLET in 1 BOTTLE (72189-598-30) 30 tablet2024-12-16NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Lurasidone HCLDirect_rx2024-12-16HUMAN PRESCRIPTION DRUG LABEL1