NDC 65757-500

ARISTADA INITIO

Aripiprazole Lauroxil

ARISTADA INITIO 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: 65757-500_181e08d8-9e9d-4c7a-b2a0-d941ca5ea17f
• NDC: 65757-500
• Product Type: Human Prescription Drug
• Proprietary Name: ARISTADA INITIO
• Generic Name: Aripiprazole Lauroxil
• Dosage Form: Injection, Suspension, Extended Release
• Route of Administration: INTRAMUSCULAR
• Marketing Start Date: 2018-06-29
• Marketing Category: NDA / NDA
• Application Number: NDA209830
• Labeler Name: Alkermes, Inc.
• Substance Name: ARIPIPRAZOLE LAUROXIL
• Active Ingredient Strength: 675 mg/2.4mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 65757-500-03

1 SYRINGE in 1 CARTON (65757-500-03) > 2.4 mL in 1 SYRINGE

• Marketing Start Date: 2018-06-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65757-500-03 [65757050003]

ARISTADA INITIO INJECTION, SUSPENSION, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA209830
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-06-29

Drug Details

Active Ingredients

Ingredient	Strength
ARIPIPRAZOLE LAUROXIL	675 mg/2.4mL

OpenFDA Data

• SPL SET ID: b18fdfd9-31cd-4a2f-9f1c-ebc70d7a9403
• Manufacturer:
  • Alkermes, Inc.
• UNII:
  • B786J7A343
• RxNorm Concept Unique ID - RxCUI:
  • 2049341
  • 2049343

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

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