lurasidone hydrochloride

Product NDC
50090-7170
11-digit product format
500907170
Labeler code
50090
Product ID
50090-7170_d5b325d2-1204-4adb-b105-0bd981f990dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lurasidone hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA212244
Marketing category
ANDA
Marketing start
2023-01-04
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
50090-7170-0lurasidone hydrochloride30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7170-0EA - Each50090-7170d6fb6f1f-c432-40b6-890e-75efd1957f6112024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7170LURASIDONE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20240521_c96cbfc9-773b-410a-ada3-2822cbd58f8f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1235247lurasidone HCl 20 MG Oral TabletPSNc96cbfc9-773b-410a-ada3-2822cbd58f8f1
1235247lurasidone hydrochloride 20 MG Oral TabletSCDc96cbfc9-773b-410a-ada3-2822cbd58f8f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7170-05009071700030 TABLET, FILM COATED in 1 BOTTLE (50090-7170-0) 2024-05-15NoNoCurrent