FDA.reportPublic FDA data

Lurasidone Hydrochloride

Product NDC
31722-082
11-digit product format
317220082
Labeler code
31722
Product ID
31722-082_3a429e3e-35e3-c6bb-e063-6294a90ac9ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lurasidone Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA218174
Marketing category
ANDA
Marketing start
2024-08-21
Substance
LURASIDONE HYDROCHLORIDE
Active strength
60 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 HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO0P4I5851I
Rxcui1040031, 1040041, 1235247, 1297278, 1431235

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
31722-082-05Lurasidone Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5002
31722-082-30Lurasidone Hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
31722-082-90Lurasidone Hydrochloride90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-082-30EA - Each31722-0829c253d50-f728-4615-afcf-4e962b00166f12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-082LURASIDONE HYDROCHLORIDE (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1Current NDC, 3 package rows20241020_c80625bb-7857-4763-81fe-542b3448d84f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1297278lurasidone HCl 120 MG Oral TabletPSNc80625bb-7857-4763-81fe-542b3448d84f2
1235247lurasidone HCl 20 MG Oral TabletPSNc80625bb-7857-4763-81fe-542b3448d84f2
1040031lurasidone HCl 40 MG Oral TabletPSNc80625bb-7857-4763-81fe-542b3448d84f2
1431235lurasidone HCl 60 MG Oral TabletPSNc80625bb-7857-4763-81fe-542b3448d84f2
1040041lurasidone HCl 80 MG Oral TabletPSNc80625bb-7857-4763-81fe-542b3448d84f2
1297278lurasidone hydrochloride 120 MG Oral TabletSCDc80625bb-7857-4763-81fe-542b3448d84f2
1235247lurasidone hydrochloride 20 MG Oral TabletSCDc80625bb-7857-4763-81fe-542b3448d84f2
1040031lurasidone hydrochloride 40 MG Oral TabletSCDc80625bb-7857-4763-81fe-542b3448d84f2
1431235lurasidone hydrochloride 60 MG Oral TabletSCDc80625bb-7857-4763-81fe-542b3448d84f2
1040041lurasidone hydrochloride 80 MG Oral TabletSCDc80625bb-7857-4763-81fe-542b3448d84f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
31722-082-0531722008205500 TABLET, FILM COATED in 1 BOTTLE (31722-082-05) 2024-08-21NoNoHistorical
31722-082-303172200823030 TABLET, FILM COATED in 1 BOTTLE (31722-082-30) 2024-08-21NoNoHistorical
31722-082-903172200829090 TABLET, FILM COATED in 1 BOTTLE (31722-082-90) 2024-08-21NoNoHistorical