FDA.reportPublic FDA data

Vraylar

Product NDC
61874-160
11-digit product format
618740160
Labeler code
61874
Product ID
61874-160_db2154b0-f0c7-403c-95fd-794666e79e30
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cariprazine
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Allergan, Inc.
Application
NDA204370
Marketing category
NDA
Marketing start
2015-09-17
Substance
CARIPRAZINE
Active strength
6 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
Vraylar
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARIPRAZINE6 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF6RJL8B278
Rxcui1667660, 1667666, 1667668, 1667670, 1667672, 1667674, 1667676, 1667678, 1741746, 1741747, 2729792, 2729794, 2729796, 2729798

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8bcf2fc0-7296-43a8-8a9f-34fc790c26bcProduct name120150929

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61874-160-07Vraylar7 in 1 BLISTER PACKCAPSULE, GELATIN COATED730
61874-160-30Vraylar30 in 1 BOTTLECAPSULE, GELATIN COATED3030
61874-160-90Vraylar90 in 1 BOTTLECAPSULE, GELATIN COATED9030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61874-160-30EA - Each61874-1602f75520f-5c6d-4a65-bf42-33cb0da229e412016-03-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
cariprazineACTIVE INGREDIENTF6RJL8B278VRAYLAR (CARIPRAZINE) CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]2
cariprazineACTIVE MOIETYF6RJL8B278VRAYLAR (CARIPRAZINE) CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDVRAYLAR (CARIPRAZINE) CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]2
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYVRAYLAR (CARIPRAZINE) CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAVRAYLAR (CARIPRAZINE) CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTVRAYLAR (CARIPRAZINE) CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]2
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357VRAYLAR (CARIPRAZINE) CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]2
gelatinINACTIVE INGREDIENT2G86QN327LVRAYLAR (CARIPRAZINE) CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30VRAYLAR (CARIPRAZINE) CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]2
shellacINACTIVE INGREDIENT46N107B71OVRAYLAR (CARIPRAZINE) CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]2
starch, cornINACTIVE INGREDIENTO8232NY3SJVRAYLAR (CARIPRAZINE) CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPVRAYLAR (CARIPRAZINE) CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61874-160VRAYLAR (CARIPRAZINE) CAPSULE, GELATIN COATED VRAYLAR (CARIPRAZINE) KIT [ALLERGAN, INC.]26Current NDC, Legacy NDC, 3 package rows20241206_4b5f7c65-aa2d-452a-b3db-bc85c06ff12f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1741747{1 (cariprazine 1.5 MG Oral Capsule [Vraylar]) / 6 (cariprazine 3 MG Oral Capsule [Vraylar]) } Pack [Vraylar 1.5/3 Mixed Pack]BPCK4b5f7c65-aa2d-452a-b3db-bc85c06ff12f30
1741746{1 (cariprazine 1.5 MG Oral Capsule) / 6 (cariprazine 3 MG Oral Capsule) } PackGPCK4b5f7c65-aa2d-452a-b3db-bc85c06ff12f30
2729792cariprazine 0.5 MG Oral CapsulePSN4b5f7c65-aa2d-452a-b3db-bc85c06ff12f30
2729796cariprazine 0.75 MG Oral CapsulePSN4b5f7c65-aa2d-452a-b3db-bc85c06ff12f30
1667660cariprazine 1.5 MG Oral CapsulePSN4b5f7c65-aa2d-452a-b3db-bc85c06ff12f30
1741746cariprazine 1.5/3 mixed packPSN4b5f7c65-aa2d-452a-b3db-bc85c06ff12f30
1667668cariprazine 3 MG Oral CapsulePSN4b5f7c65-aa2d-452a-b3db-bc85c06ff12f30
1667672cariprazine 4.5 MG Oral CapsulePSN4b5f7c65-aa2d-452a-b3db-bc85c06ff12f30
1667676cariprazine 6 MG Oral CapsulePSN4b5f7c65-aa2d-452a-b3db-bc85c06ff12f30
2729794Vraylar 0.5 MG Oral CapsulePSN4b5f7c65-aa2d-452a-b3db-bc85c06ff12f30
2729798Vraylar 0.75 MG Oral CapsulePSN4b5f7c65-aa2d-452a-b3db-bc85c06ff12f30
1667666Vraylar 1.5 MG Oral CapsulePSN4b5f7c65-aa2d-452a-b3db-bc85c06ff12f30
1741747Vraylar 1.5/3 Mixed PackPSN4b5f7c65-aa2d-452a-b3db-bc85c06ff12f30
1667670Vraylar 3 MG Oral CapsulePSN4b5f7c65-aa2d-452a-b3db-bc85c06ff12f30
1667674Vraylar 4.5 MG Oral CapsulePSN4b5f7c65-aa2d-452a-b3db-bc85c06ff12f30
1667678Vraylar 6 MG Oral CapsulePSN4b5f7c65-aa2d-452a-b3db-bc85c06ff12f30
2729794cariprazine 0.5 MG Oral Capsule [Vraylar]SBD4b5f7c65-aa2d-452a-b3db-bc85c06ff12f30
2729798cariprazine 0.75 MG Oral Capsule [Vraylar]SBD4b5f7c65-aa2d-452a-b3db-bc85c06ff12f30
1667666cariprazine 1.5 MG Oral Capsule [Vraylar]SBD4b5f7c65-aa2d-452a-b3db-bc85c06ff12f30
1667670cariprazine 3 MG Oral Capsule [Vraylar]SBD4b5f7c65-aa2d-452a-b3db-bc85c06ff12f30
1667674cariprazine 4.5 MG Oral Capsule [Vraylar]SBD4b5f7c65-aa2d-452a-b3db-bc85c06ff12f30
1667678cariprazine 6 MG Oral Capsule [Vraylar]SBD4b5f7c65-aa2d-452a-b3db-bc85c06ff12f30
2729792cariprazine 0.5 MG Oral CapsuleSCD4b5f7c65-aa2d-452a-b3db-bc85c06ff12f30
2729796cariprazine 0.75 MG Oral CapsuleSCD4b5f7c65-aa2d-452a-b3db-bc85c06ff12f30
1667660cariprazine 1.5 MG Oral CapsuleSCD4b5f7c65-aa2d-452a-b3db-bc85c06ff12f30
1667668cariprazine 3 MG Oral CapsuleSCD4b5f7c65-aa2d-452a-b3db-bc85c06ff12f30
1667672cariprazine 4.5 MG Oral CapsuleSCD4b5f7c65-aa2d-452a-b3db-bc85c06ff12f30
1667676cariprazine 6 MG Oral CapsuleSCD4b5f7c65-aa2d-452a-b3db-bc85c06ff12f30
2729792cariprazine (as cariprazine hydrochloride) 0.5 MG Oral CapsuleSY4b5f7c65-aa2d-452a-b3db-bc85c06ff12f30
2729796cariprazine (as cariprazine hydrochloride) 0.75 MG Oral CapsuleSY4b5f7c65-aa2d-452a-b3db-bc85c06ff12f30
1741746cariprazine 1.5/3 mixed packSY4b5f7c65-aa2d-452a-b3db-bc85c06ff12f30
2729794Vraylar 0.5 MG Oral CapsuleSY4b5f7c65-aa2d-452a-b3db-bc85c06ff12f30
2729798Vraylar 0.75 MG Oral CapsuleSY4b5f7c65-aa2d-452a-b3db-bc85c06ff12f30
1667666Vraylar 1.5 MG Oral CapsuleSY4b5f7c65-aa2d-452a-b3db-bc85c06ff12f30
1741747Vraylar 1.5/3 Mixed PackSY4b5f7c65-aa2d-452a-b3db-bc85c06ff12f30
1667670Vraylar 3 MG Oral CapsuleSY4b5f7c65-aa2d-452a-b3db-bc85c06ff12f30
1667674Vraylar 4.5 MG Oral CapsuleSY4b5f7c65-aa2d-452a-b3db-bc85c06ff12f30
1667678Vraylar 6 MG Oral CapsuleSY4b5f7c65-aa2d-452a-b3db-bc85c06ff12f30

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61874-160-07618740160077 CAPSULE, GELATIN COATED in 1 BLISTER PACK (61874-160-07) 2016-03-010000-00-00YesNoCurrent
61874-160-306187401603030 CAPSULE, GELATIN COATED in 1 BOTTLE (61874-160-30) 2016-03-010000-00-00NoNoCurrent
61874-160-906187401609090 in 1 BOTTLEHistorical