Latuda

Product NDC
70518-3010
11-digit product format
705183010
Labeler code
70518
Product ID
70518-3010_ba731448-9583-210c-e053-2a95a90abd7a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lurasidone hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
NDA200603
Marketing category
NDA
Marketing start
2021-02-02
Marketing end
0000-00-00
Substance
LURASIDONE HYDROCHLORIDE
Active strength
80 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3010-02025-09-08C16284748780-1f386c649-d75c-0266-e053-dadaa90a7c1a2a26c9b9-4436-48b2-9c5d-d0af4500ad57
70518-3010-02023-01-30C16284748780-1f386c649-d75c-0266-e053-dadaa90a7c1a2a26c9b9-4436-48b2-9c5d-d0af4500ad57

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3010LATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [REMEDYREPACK INC.]1Legacy NDC20210204_2a26c9b9-4436-48b2-9c5d-d0af4500ad57.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3010-07051830100030 POUCH in 1 BOX (70518-3010-0) > 1 TABLET, FILM COATED in 1 POUCH (70518-3010-1) 30 pouch2021-02-020000-00-00NoNoCurrent