NDC 50458-608

INVEGA TRINZA

Paliperidone Palmitate

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

• Product ID: 50458-608_1ef256dc-8107-11eb-98e1-81dffb2ca371
• NDC: 50458-608
• Product Type: Human Prescription Drug
• Proprietary Name: INVEGA TRINZA
• Generic Name: Paliperidone Palmitate
• Dosage Form: Injection, Suspension, Extended Release
• Route of Administration: INTRAMUSCULAR
• Marketing Start Date: 2015-05-19
• Marketing Category: NDA / NDA
• Application Number: NDA207946
• Labeler Name: Janssen Pharmaceuticals, Inc
• Substance Name: PALIPERIDONE PALMITATE
• Active Ingredient Strength: 546 mg/1.75mL
• Pharm Classes: Atypical Antipsychotic [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 50458-608-01

1 SYRINGE in 1 KIT (50458-608-01) > 1 mL in 1 SYRINGE

• Marketing Start Date: 2015-05-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50458-608-01 [50458060801]

INVEGA TRINZA INJECTION, SUSPENSION, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA207946
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-05-19

Drug Details

Active Ingredients

Ingredient	Strength
PALIPERIDONE PALMITATE	546 mg/1.75mL

OpenFDA Data

• SPL SET ID: c39e65d7-fa44-4e4c-8b12-a654d3ed0eae
• Manufacturer:
  • Janssen Pharmaceuticals, Inc
• UNII:
  • R8P8USM8FR
• RxNorm Concept Unique ID - RxCUI:
  • 1650968
  • 1650975
  • 1650974
  • 1650976
  • 1650971
  • 1650973
  • 1650972
  • 1650966

Pharmacological Class

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

Medicade Reported Pricing

50458060801 INVEGA TRINZA 546 MG/1.75 ML

Pricing Unit: ML | Drug Type:

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

NDC	Brand Name	Generic Name
50458-606	INVEGA TRINZA	paliperidone palmitate
50458-607	INVEGA TRINZA	paliperidone palmitate
50458-608	INVEGA TRINZA	paliperidone palmitate
50458-609	INVEGA TRINZA	INVEGA TRINZA
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