FDA.reportPublic FDA data

ARISTADA INITIO

Product NDC
65757-500
11-digit product format
657570500
Labeler code
65757
Product ID
65757-500_cbde23b9-60d1-4ae1-b42d-1093610ba18d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
aripiprazole lauroxil
Dosage form
INJECTION, SUSPENSION, EXTENDED RELEASE
Route
INTRAMUSCULAR
Labeler
Alkermes, Inc.
Application
NDA209830
Marketing category
NDA
Marketing start
2018-06-29
Substance
ARIPIPRAZOLE LAUROXIL
Active strength
675 mg/2.4mL
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
ARISTADA INITIO
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARIPIPRAZOLE LAUROXIL675 mg/2.4mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB786J7A343
Rxcui2049341, 2049343

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
915afeb5-0b22-42c0-86ea-77abf1c5fe15Product name120250307
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
51c1e9bf-32c5-4a7b-b010-f93a90af7b6eProduct name120231010
34645f32-2ac4-41bf-9c61-8107e4764a26Product name120181210
f8ff9e17-cd6c-4547-98c3-f5db0d1fc25dProduct name120180110
14eaf619-f285-4cd0-9f39-d9dd8f3d9c02Product name120170824
7af8ba3d-8c7a-4c9f-806c-a55cd50e39beProduct name120170725
8223ef47-de85-24dd-a9c7-5a041d2634a2Product name920170223
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65757-500-03ARISTADA INITIO2.4 mL in 1 SYRINGEINJECTION, SUSPENSION, EXTENDED2.416
65757-500-03ARISTADA INITIO1 in 1 CARTONINJECTION, SUSPENSION, EXTENDED116
65757-500-04ARISTADA INITIO2.4 mL in 1 SYRINGEINJECTION, SUSPENSION, EXTENDED2.416
65757-500-04ARISTADA INITIO1 in 1 CARTONINJECTION, SUSPENSION, EXTENDED116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65757-500-03ML - Milliliter65757-5002c96eec6-8459-4f31-b994-96cdd96e7f9f12018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65757-500ARISTADA INITIO (ARIPIPRAZOLE LAUROXIL) INJECTION, SUSPENSION, EXTENDED RELEASE [ALKERMES, INC.]16Current NDC, Legacy NDC, 4 package rows20250210_b18fdfd9-31cd-4a2f-9f1c-ebc70d7a9403.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2049341ARIPiprazole lauroxil 675 MG in 2.4 ML Prefilled SyringePSNb18fdfd9-31cd-4a2f-9f1c-ebc70d7a940316
2049343Aristada Initio Starter Dose 675 MG in 2.4 ML Prefilled SyringePSNb18fdfd9-31cd-4a2f-9f1c-ebc70d7a940316
20493432.4 ML aripiprazole lauroxil 281.3 MG/ML Prefilled Syringe [Aristada]SBDb18fdfd9-31cd-4a2f-9f1c-ebc70d7a940316
20493412.4 ML aripiprazole lauroxil 281.3 MG/ML Prefilled SyringeSCDb18fdfd9-31cd-4a2f-9f1c-ebc70d7a940316
20493432.4 ML Aristada 281.25 MG/ML Extended Release Suspension Prefilled SyringeSYb18fdfd9-31cd-4a2f-9f1c-ebc70d7a940316
2049341aripiprazole lauroxil 675 MG per 2.4 ML Prefilled SyringeSYb18fdfd9-31cd-4a2f-9f1c-ebc70d7a940316
2049343Aristada 675 MG per 2.4 ML Prefilled SyringeSYb18fdfd9-31cd-4a2f-9f1c-ebc70d7a940316
2049343Aristada Initio Starter Dose 281.3 MG/ML per 2.4 ML Prefilled SyringeSYb18fdfd9-31cd-4a2f-9f1c-ebc70d7a940316

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65757-500-03657570500031 SYRINGE in 1 CARTON (65757-500-03) / 2.4 mL in 1 SYRINGE1 syringe2018-06-290000-00-00NoNoCurrent
65757-500-04657570500041 SYRINGE in 1 CARTON (65757-500-04) / 2.4 mL in 1 SYRINGE1 syringe2018-06-290000-00-00YesNoCurrent