NDC 50458-561

INVEGA SUSTENNA

Paliperidone Palmitate

INVEGA SUSTENNA is a Intramuscular Injection in the Human Prescription Drug category. It is labeled and distributed by Janssen Pharmaceuticals, Inc.. The primary component is Paliperidone Palmitate.

• Product ID: 50458-561_86e7f21e-638b-11ea-8ce6-7c2bfc2ca371
• NDC: 50458-561
• Product Type: Human Prescription Drug
• Proprietary Name: INVEGA SUSTENNA
• Generic Name: Paliperidone Palmitate
• Dosage Form: Injection
• Route of Administration: INTRAMUSCULAR
• Marketing Start Date: 2009-07-31
• Marketing Category: NDA / NDA
• Application Number: NDA022264
• Labeler Name: Janssen Pharmaceuticals, Inc.
• Substance Name: PALIPERIDONE PALMITATE
• Active Ingredient Strength: 78 mg/.5mL
• Pharm Classes: Atypical Antipsychotic [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 50458-561-01

1 SYRINGE in 1 KIT (50458-561-01) > .5 mL in 1 SYRINGE

• Marketing Start Date: 2009-07-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50458-561-01 [50458056101]

INVEGA SUSTENNA INJECTION

• Marketing Category: NDA
• Application Number: NDA022264
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2009-07-31

Drug Details

Active Ingredients

Ingredient	Strength
PALIPERIDONE PALMITATE	78 mg/.5mL

OpenFDA Data

• SPL SET ID: 1af14e42-951d-414d-8564-5d5fce138554
• Manufacturer:
  • Janssen Pharmaceuticals, Inc.
• UNII:
  • R8P8USM8FR
• RxNorm Concept Unique ID - RxCUI:
  • 858057
  • 858074
  • 858051
  • 858052
  • 858053
  • 858054
  • 858055
  • 858056
  • 858048
  • 858073

Pharmacological Class

• Atypical Antipsychotic [EPC]
• Atypical Antipsychotic [EPC]

Medicade Reported Pricing

50458056101 INVEGA SUSTENNA 78 MG/0.5 ML

Pricing Unit: ML | Drug Type:

NDC Crossover Matching brand name "INVEGA SUSTENNA" or generic name "Paliperidone Palmitate"

NDC	Brand Name	Generic Name
50458-560	INVEGA SUSTENNA	paliperidone palmitate
50458-561	INVEGA SUSTENNA	paliperidone palmitate
50458-562	INVEGA SUSTENNA	paliperidone palmitate
50458-563	INVEGA SUSTENNA	paliperidone palmitate
50458-564	INVEGA SUSTENNA	paliperidone palmitate
50458-606	INVEGA TRINZA	paliperidone palmitate
50458-607	INVEGA TRINZA	paliperidone palmitate
50458-608	INVEGA TRINZA	paliperidone palmitate