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 ID: 65757-401_1d4131ab-13f2-4fb7-8772-cc5b01bfc4e7
• NDC: 65757-401
• Product Type: Human Prescription Drug
• Proprietary Name: ARISTADA
• Generic Name: Aripiprazole Lauroxil
• Dosage Form: Injection, Suspension, Extended Release
• Route of Administration: INTRAMUSCULAR
• Marketing Start Date: 2015-10-05
• Marketing Category: NDA / NDA
• Application Number: NDA207533
• Labeler Name: Alkermes, Inc.
• Substance Name: ARIPIPRAZOLE LAUROXIL
• Active Ingredient Strength: 441 mg/1.6mL
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 65757-401-03

1 SYRINGE in 1 CARTON (65757-401-03) > 1.6 mL in 1 SYRINGE

• Marketing Start Date: 2015-10-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65757-401-01 [65757040101]

ARISTADA INJECTION, SUSPENSION, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA207533
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-10-05
• Marketing End Date: 2018-10-15

NDC 65757-401-03 [65757040103]

ARISTADA INJECTION, SUSPENSION, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA207533
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-10-05

Drug Details

Active Ingredients

Ingredient	Strength
ARIPIPRAZOLE LAUROXIL	441 mg/1.6mL

OpenFDA Data

• SPL SET ID: 17a8d11b-73b0-4833-a0b4-cf1ef85edefb
• Manufacturer:
  • Alkermes, Inc.
• UNII:
  • B786J7A343
• 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"

NDC	Brand Name	Generic Name
65757-401	ARISTADA	aripiprazole lauroxil
65757-402	ARISTADA	aripiprazole lauroxil
65757-403	ARISTADA	aripiprazole lauroxil
65757-404	ARISTADA	aripiprazole lauroxil
65757-500	ARISTADA INITIO	aripiprazole lauroxil