NDC 50458-554

INVEGA

Paliperidone

INVEGA is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Janssen Pharmaceuticals, Inc.. The primary component is Paliperidone.

• Product ID: 50458-554_25b1fbca-09c7-11ea-b666-8f2d192adfa6
• NDC: 50458-554
• Product Type: Human Prescription Drug
• Proprietary Name: INVEGA
• Generic Name: Paliperidone
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2009-09-10
• Marketing Category: NDA / NDA
• Application Number: NDA021999
• Labeler Name: Janssen Pharmaceuticals, Inc.
• Substance Name: PALIPERIDONE
• Active Ingredient Strength: 2 mg/1
• Pharm Classes: Atypical Antipsychotic [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 50458-554-01

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-554-01)

• Marketing Start Date: 2009-09-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50458-554-10 [50458055410]

INVEGA TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA021999
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-09-10

NDC 50458-554-98 [50458055498]

INVEGA TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA021999
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-09-10
• Marketing End Date: 2017-06-28

NDC 50458-554-01 [50458055401]

INVEGA TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA021999
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-09-10

Drug Details

Active Ingredients

Ingredient	Strength
PALIPERIDONE	1.5 mg/1

OpenFDA Data

• SPL SET ID: 7b8e5b26-b9e4-4704-921b-3c3c0d159916
• Manufacturer:
  • Janssen Pharmaceuticals, Inc.
• UNII:
  • 838F01T721
• RxNorm Concept Unique ID - RxCUI:
  • 672567
  • 686445
  • 672571
  • 686443
  • 686441
  • 866103
  • 866105
  • 672569

Pharmacological Class

• Atypical Antipsychotic [EPC]

Medicade Reported Pricing

50458055401 INVEGA ER 1.5 MG TABLET

Pricing Unit: EA | Drug Type:

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

NDC	Brand Name	Generic Name
21695-455	INVEGA	INVEGA
50458-552	INVEGA	INVEGA
50458-554	INVEGA	INVEGA
50458-550	INVEGA	INVEGA
50458-551	INVEGA	INVEGA
64725-0550	INVEGA	INVEGA
0378-3978	Paliperidone	paliperidone
0378-3979	Paliperidone	paliperidone
0378-3980	Paliperidone	paliperidone
0378-3981	Paliperidone	paliperidone
0591-3692	Paliperidone	Paliperidone
0591-3693	Paliperidone	Paliperidone
0591-3694	Paliperidone	Paliperidone
0591-3695	Paliperidone	Paliperidone
0904-6935	Paliperidone	Paliperidone
0904-6936	Paliperidone	Paliperidone
0904-6937	Paliperidone	Paliperidone
10147-0951	Paliperidone	paliperidone
10147-0952	Paliperidone	paliperidone
10147-0953	Paliperidone	paliperidone