lurasidone hydrochloride

Product NDC
50090-7078
11-digit product format
500907078
Labeler code
50090
Product ID
50090-7078_4f7ceeb8-872a-4e89-b8bd-e198d939acf0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lurasidone hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA212091
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

Additional Listing Data#

Finished product
Yes
Brand name base
lurasidone hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LURASIDONE HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO0P4I5851I
Rxcui1235247

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
86802824-8cc9-f7e2-fc5f-652f1d04e1a2Product name820250804

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7078-0lurasidone hydrochloride30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7078-0EA - Each50090-707897cfab84-6de2-4eee-ac90-d92b21864ec412024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7078LURASIDONE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20240208_b848e6f3-63c0-4d2e-bda5-c9e961472092.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1235247lurasidone HCl 20 MG Oral TabletPSNb848e6f3-63c0-4d2e-bda5-c9e9614720921
1235247lurasidone hydrochloride 20 MG Oral TabletSCDb848e6f3-63c0-4d2e-bda5-c9e9614720921

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7078-05009070780030 TABLET, FILM COATED in 1 BOTTLE (50090-7078-0) 2024-01-31NoNoCurrent