NDC 65757-401

ARISTADA

Aripiprazole Lauroxil

ARISTADA is a Intramuscular Injection, Suspension, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Alkermes, Inc.. The primary component is Aripiprazole Lauroxil.

Product ID65757-401_1d4131ab-13f2-4fb7-8772-cc5b01bfc4e7
NDC65757-401
Product TypeHuman Prescription Drug
Proprietary NameARISTADA
Generic NameAripiprazole Lauroxil
Dosage FormInjection, Suspension, Extended Release
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2015-10-05
Marketing CategoryNDA / NDA
Application NumberNDA207533
Labeler NameAlkermes, Inc.
Substance NameARIPIPRAZOLE LAUROXIL
Active Ingredient Strength441 mg/1.6mL
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 65757-401-03

1 SYRINGE in 1 CARTON (65757-401-03) > 1.6 mL in 1 SYRINGE
Marketing Start Date2015-10-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65757-401-01 [65757040101]

ARISTADA INJECTION, SUSPENSION, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA207533
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-10-05
Marketing End Date2018-10-15

NDC 65757-401-03 [65757040103]

ARISTADA INJECTION, SUSPENSION, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA207533
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-10-05

Drug Details

Active Ingredients

IngredientStrength
ARIPIPRAZOLE LAUROXIL441 mg/1.6mL

OpenFDA Data

SPL SET ID:17a8d11b-73b0-4833-a0b4-cf1ef85edefb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1673269
  • 1673280
  • 1673278
  • 1673274
  • 1673277
  • 1925264
  • 1673279
  • 1925262
  • Medicade Reported Pricing

    65757040103 ARISTADA ER 441 MG/1.6 ML SYRN

    Pricing Unit: ML | Drug Type:

    65757040101 ARISTADA ER 441 MG/1.6 ML SYRN

    Pricing Unit: ML | Drug Type:

    NDC Crossover Matching brand name "ARISTADA" or generic name "Aripiprazole Lauroxil"

    NDCBrand NameGeneric Name
    65757-401ARISTADAaripiprazole lauroxil
    65757-402ARISTADAaripiprazole lauroxil
    65757-403ARISTADAaripiprazole lauroxil
    65757-404ARISTADAaripiprazole lauroxil
    65757-500ARISTADA INITIOaripiprazole lauroxil

    Trademark Results [ARISTADA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ARISTADA
    ARISTADA
    90765853 not registered Live/Pending
    Alkermes Pharma Ireland Limited
    2021-06-10
    ARISTADA
    ARISTADA
    90765846 not registered Live/Pending
    Alkermes Pharma Ireland Limited
    2021-06-10
    ARISTADA
    ARISTADA
    87806402 5519704 Live/Registered
    Alkermes Pharma Ireland Limited
    2018-02-22
    ARISTADA
    ARISTADA
    87189103 5392594 Live/Registered
    Alkermes Pharma Ireland Limited
    2016-09-30
    ARISTADA
    ARISTADA
    86388951 4942168 Live/Registered
    Alkermes Pharma Ireland Limited
    2014-09-09
    ARISTADA
    ARISTADA
    85619287 4893254 Live/Registered
    ALKERMES PHARMA IRELAND LIMITED
    2012-05-08

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