FDA.reportPublic FDA data

CAPLYTA

Product NDC
72060-110
11-digit product format
720600110
Labeler code
72060
Product ID
72060-110_160162e3-e8aa-4783-bd98-adf4c96ad2c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lumateperone
Dosage form
CAPSULE
Route
ORAL
Labeler
Intra-Cellular Therapies, Inc
Application
NDA209500
Marketing category
NDA
Marketing start
2022-08-09
Substance
LUMATEPERONE
Active strength
10.5 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CAPLYTA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LUMATEPERONE10.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii70BSQ12069
Rxcui2275607, 2275613, 2607529, 2607531, 2607533, 2607535

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
be572206-b036-4503-934b-e830606fefaeProduct name120200107

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72060-110-07CAPLYTA7 in 1 BOTTLECAPSULE726
72060-110-40CAPLYTA30 in 1 BOTTLECAPSULE3026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72060-110-40EA - Each72060-11093bdd61a-7331-4db9-b386-873b16bbbc2412022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72060-110CAPLYTA (LUMATEPERONE) CAPSULE [INTRA-CELLULAR THERAPIES, INC]18Current NDC, Legacy NDC, 2 package rows20240927_db730b06-6351-47fd-8183-e61e61bbead5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2607531CAPLYTA 10.5 MG Oral CapsulePSNdb730b06-6351-47fd-8183-e61e61bbead527
2607535CAPLYTA 21 MG Oral CapsulePSNdb730b06-6351-47fd-8183-e61e61bbead527
2275613CAPLYTA 42 MG Oral CapsulePSNdb730b06-6351-47fd-8183-e61e61bbead527
2607529lumateperone 10.5 MG Oral CapsulePSNdb730b06-6351-47fd-8183-e61e61bbead527
2607533lumateperone 21 MG Oral CapsulePSNdb730b06-6351-47fd-8183-e61e61bbead527
2275607lumateperone 42 MG Oral CapsulePSNdb730b06-6351-47fd-8183-e61e61bbead527
2607531lumateperone 10.5 MG Oral Capsule [Caplyta]SBDdb730b06-6351-47fd-8183-e61e61bbead527
2607535lumateperone 21 MG Oral Capsule [Caplyta]SBDdb730b06-6351-47fd-8183-e61e61bbead527
2275613lumateperone 42 MG Oral Capsule [Caplyta]SBDdb730b06-6351-47fd-8183-e61e61bbead527
2607529lumateperone 10.5 MG Oral CapsuleSCDdb730b06-6351-47fd-8183-e61e61bbead527
2607533lumateperone 21 MG Oral CapsuleSCDdb730b06-6351-47fd-8183-e61e61bbead527
2275607lumateperone 42 MG Oral CapsuleSCDdb730b06-6351-47fd-8183-e61e61bbead527
2607531Caplyta 10.5 MG Oral CapsuleSYdb730b06-6351-47fd-8183-e61e61bbead527
2607535Caplyta 21 MG Oral CapsuleSYdb730b06-6351-47fd-8183-e61e61bbead527
2275613Caplyta 42 MG (equivalent to lumateperone tosylate 60 MG) Oral CapsuleSYdb730b06-6351-47fd-8183-e61e61bbead527
2275613Caplyta 42 MG Oral CapsuleSYdb730b06-6351-47fd-8183-e61e61bbead527
2607529lumateperone 10.5 MG (as lumateperone tosylate 15 MG) Oral CapsuleSYdb730b06-6351-47fd-8183-e61e61bbead527
2607533lumateperone 21 MG (as lumateperone tosylate 30 MG) Oral CapsuleSYdb730b06-6351-47fd-8183-e61e61bbead527
2275607lumateperone 42 MG (equivalent to lumateperone tosylate 60 MG) Oral CapsuleSYdb730b06-6351-47fd-8183-e61e61bbead527

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72060-110-07720600110077 CAPSULE in 1 BOTTLE (72060-110-07) 7 capsule2023-06-01YesNoCurrent
72060-110-407206001104030 CAPSULE in 1 BOTTLE (72060-110-40) 30 capsule2022-08-090000-00-00NoNoCurrent