FDA.reportPublic FDA data

Lurasidone Hydrochloride

Product NDC
31722-080
11-digit product format
317220080
Labeler code
31722
Product ID
31722-080_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
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
Rxcui1040031, 1040041, 1235247, 1297278, 1431235

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
86802824-8cc9-f7e2-fc5f-652f1d04e1a2Product name820250804
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-080-05Lurasidone Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5002
31722-080-30Lurasidone Hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
31722-080-90Lurasidone Hydrochloride90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-080-30EA - Each31722-0807137078b-a213-4b63-8de3-589d00b566a112025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-080LURASIDONE 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 TabletPSN0115b2fa-4c11-4f91-abe7-8293903e066c2
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 TabletSCD0115b2fa-4c11-4f91-abe7-8293903e066c2
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
31722-080-0531722008005500 TABLET, FILM COATED in 1 BOTTLE (31722-080-05) 2024-08-21NoNoCurrent
31722-080-303172200803030 TABLET, FILM COATED in 1 BOTTLE (31722-080-30) 2024-08-21NoNoCurrent
31722-080-903172200809090 TABLET, FILM COATED in 1 BOTTLE (31722-080-90) 2024-08-21NoNoCurrent