FDA.reportPublic FDA data

ARISTADA

Product NDC
65757-404
11-digit product format
657570404
Labeler code
65757
Product ID
65757-404_3d951a36-1e73-4f84-8ebf-4d556d81a086
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
aripiprazole lauroxil
Dosage form
INJECTION, SUSPENSION, EXTENDED RELEASE
Route
INTRAMUSCULAR
Labeler
Alkermes, Inc.
Application
NDA207533
Marketing category
NDA
Marketing start
2017-06-05
Substance
ARIPIPRAZOLE LAUROXIL
Active strength
1064 mg/3.9mL
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARIPIPRAZOLE LAUROXIL1064 mg/3.9mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB786J7A343
Rxcui1673269, 1673274, 1673277, 1673278, 1673279, 1673280, 1925262, 1925264

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
915afeb5-0b22-42c0-86ea-77abf1c5fe15Product name120250307
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
51c1e9bf-32c5-4a7b-b010-f93a90af7b6eProduct name120231010
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
34645f32-2ac4-41bf-9c61-8107e4764a26Product name120181210
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
f8ff9e17-cd6c-4547-98c3-f5db0d1fc25dProduct name120180110
14eaf619-f285-4cd0-9f39-d9dd8f3d9c02Product name120170824
7af8ba3d-8c7a-4c9f-806c-a55cd50e39beProduct name120170725
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
8223ef47-de85-24dd-a9c7-5a041d2634a2Product name920170223
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65757-404-03ARISTADA1 in 1 CARTONINJECTION, SUSPENSION, EXTENDED132
65757-404-03ARISTADA3.9 mL in 1 SYRINGEINJECTION, SUSPENSION, EXTENDED3.932
65757-404-04ARISTADA1 in 1 CARTONINJECTION, SUSPENSION, EXTENDED132
65757-404-04ARISTADA3.9 mL in 1 SYRINGEINJECTION, SUSPENSION, EXTENDED3.932

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65757-404-01ML - Milliliter65757-404caacb56b-e6b6-4044-bd49-ac8b8957bf9912017-07-07
65757-404-03ML - Milliliter65757-40497432638-8f5f-4d58-9a0f-b5b81b2ef3e112017-07-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
aripiprazole lauroxilACTIVE INGREDIENTB786J7A343ARISTADA (ARIPIPRAZOLE LAUROXIL) INJECTION, SUSPENSION, EXTENDED RELEASE [ALKERMES, INC.]8
aripiprazole lauroxilACTIVE MOIETYB786J7A343ARISTADA (ARIPIPRAZOLE LAUROXIL) INJECTION, SUSPENSION, EXTENDED RELEASE [ALKERMES, INC.]8
Polysorbate 20INACTIVE INGREDIENT7T1F30V5YHARISTADA (ARIPIPRAZOLE LAUROXIL) INJECTION, SUSPENSION, EXTENDED RELEASE [ALKERMES, INC.]8
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XARISTADA (ARIPIPRAZOLE LAUROXIL) INJECTION, SUSPENSION, EXTENDED RELEASE [ALKERMES, INC.]8
Sodium Phosphate, Dibasic, AnhydrousINACTIVE INGREDIENT22ADO53M6FARISTADA (ARIPIPRAZOLE LAUROXIL) INJECTION, SUSPENSION, EXTENDED RELEASE [ALKERMES, INC.]8
Sodium Phosphate, Monobasic, AnhydrousINACTIVE INGREDIENTKH7I04HPUUARISTADA (ARIPIPRAZOLE LAUROXIL) INJECTION, SUSPENSION, EXTENDED RELEASE [ALKERMES, INC.]8
Sorbitan MonolaurateINACTIVE INGREDIENT6W9PS8B71JARISTADA (ARIPIPRAZOLE LAUROXIL) INJECTION, SUSPENSION, EXTENDED RELEASE [ALKERMES, INC.]8
WaterINACTIVE INGREDIENT059QF0KO0RARISTADA (ARIPIPRAZOLE LAUROXIL) INJECTION, SUSPENSION, EXTENDED RELEASE [ALKERMES, INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65757-404ARISTADA (ARIPIPRAZOLE LAUROXIL) INJECTION, SUSPENSION, EXTENDED RELEASE [ALKERMES, INC.]32Current NDC, Legacy NDC, 4 package rows20250210_17a8d11b-73b0-4833-a0b4-cf1ef85edefb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1925262ARIPiprazole lauroxil 1064 MG in 3.9 ML Prefilled SyringePSN17a8d11b-73b0-4833-a0b4-cf1ef85edefb32
1673269ARIPiprazole lauroxil 441 MG in 1.6 ML Prefilled SyringePSN17a8d11b-73b0-4833-a0b4-cf1ef85edefb32
1673277ARIPiprazole lauroxil 662 MG in 2.4 ML Prefilled SyringePSN17a8d11b-73b0-4833-a0b4-cf1ef85edefb32
1673279ARIPiprazole lauroxil 882 MG in 3.2 ML Prefilled SyringePSN17a8d11b-73b0-4833-a0b4-cf1ef85edefb32
1925264Aristada 1064 MG in 3.9 ML Prefilled SyringePSN17a8d11b-73b0-4833-a0b4-cf1ef85edefb32
1673274Aristada 441 MG in 1.6 ML Prefilled SyringePSN17a8d11b-73b0-4833-a0b4-cf1ef85edefb32
1673278Aristada 662 MG in 2.4 ML Prefilled SyringePSN17a8d11b-73b0-4833-a0b4-cf1ef85edefb32
1673280Aristada 882 MG in 3.2 ML Prefilled SyringePSN17a8d11b-73b0-4833-a0b4-cf1ef85edefb32
16732741.6 ML aripiprazole lauroxil 276 MG/ML Prefilled Syringe [Aristada]SBD17a8d11b-73b0-4833-a0b4-cf1ef85edefb32
16732782.4 ML aripiprazole lauroxil 276 MG/ML Prefilled Syringe [Aristada]SBD17a8d11b-73b0-4833-a0b4-cf1ef85edefb32
16732803.2 ML aripiprazole lauroxil 276 MG/ML Prefilled Syringe [Aristada]SBD17a8d11b-73b0-4833-a0b4-cf1ef85edefb32
19252643.9 ML aripiprazole lauroxil 273 MG/ML Prefilled Syringe [Aristada]SBD17a8d11b-73b0-4833-a0b4-cf1ef85edefb32
16732691.6 ML aripiprazole lauroxil 276 MG/ML Prefilled SyringeSCD17a8d11b-73b0-4833-a0b4-cf1ef85edefb32
16732772.4 ML aripiprazole lauroxil 276 MG/ML Prefilled SyringeSCD17a8d11b-73b0-4833-a0b4-cf1ef85edefb32
16732793.2 ML aripiprazole lauroxil 276 MG/ML Prefilled SyringeSCD17a8d11b-73b0-4833-a0b4-cf1ef85edefb32
19252623.9 ML aripiprazole lauroxil 273 MG/ML Prefilled SyringeSCD17a8d11b-73b0-4833-a0b4-cf1ef85edefb32
19252643.9 ML Aristada 273 MG/ML Prefilled SyringeSY17a8d11b-73b0-4833-a0b4-cf1ef85edefb32
1925262aripiprazole lauroxil 1064 MG per 3.9 ML Prefilled SyringeSY17a8d11b-73b0-4833-a0b4-cf1ef85edefb32
1673277aripiprazole lauroxil 276 MG/ML per 2.4 ML Prefilled SyringeSY17a8d11b-73b0-4833-a0b4-cf1ef85edefb32
1673279aripiprazole lauroxil 276 MG/ML per 3.2 ML Prefilled SyringeSY17a8d11b-73b0-4833-a0b4-cf1ef85edefb32
1673269aripiprazole lauroxil 441 MG per 1.6 ML Extended Release Suspension Prefilled SyringeSY17a8d11b-73b0-4833-a0b4-cf1ef85edefb32
1673269aripiprazole lauroxil 441 MG per 1.6 ML Prefilled SyringeSY17a8d11b-73b0-4833-a0b4-cf1ef85edefb32
1673277aripiprazole lauroxil 662 MG per 2.4 ML Prefilled SyringeSY17a8d11b-73b0-4833-a0b4-cf1ef85edefb32
1673279aripiprazole lauroxil 882 MG per 3.2 ML Prefilled SyringeSY17a8d11b-73b0-4833-a0b4-cf1ef85edefb32
1925264Aristada 1064 MG per 3.9 ML Prefilled SyringeSY17a8d11b-73b0-4833-a0b4-cf1ef85edefb32
1925264Aristada 273 MG/ML per 3.9 ML PrefilledSY17a8d11b-73b0-4833-a0b4-cf1ef85edefb32
1673278Aristada 276 MG/ML per 2.4 ML Prefilled SyringeSY17a8d11b-73b0-4833-a0b4-cf1ef85edefb32
1673280Aristada 276 MG/ML per 3.2 ML Prefilled SyringeSY17a8d11b-73b0-4833-a0b4-cf1ef85edefb32
1673274Aristada 441 MG per 1.6 ML Extended Release Suspension Prefilled SyringeSY17a8d11b-73b0-4833-a0b4-cf1ef85edefb32
1673274Aristada 441 MG per 1.6 ML Prefilled SyringeSY17a8d11b-73b0-4833-a0b4-cf1ef85edefb32
1673278Aristada 662 MG per 2.4 ML Prefilled SyringeSY17a8d11b-73b0-4833-a0b4-cf1ef85edefb32
1673280Aristada 882 MG per 3.2 ML Prefilled SyringeSY17a8d11b-73b0-4833-a0b4-cf1ef85edefb32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65757-404-03657570404031 SYRINGE in 1 CARTON (65757-404-03) / 3.9 mL in 1 SYRINGE1 syringe2017-06-050000-00-00NoNoCurrent
65757-404-04657570404041 SYRINGE in 1 CARTON (65757-404-04) / 3.9 mL in 1 SYRINGE1 syringe2017-06-050000-00-00YesNoCurrent