| Product NDC: | 50458-554 |
| Proprietary Name: | INVEGA |
| Non Proprietary Name: | paliperidone |
| Active Ingredient(s): | 1.5 mg/1 & nbsp; paliperidone |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, EXTENDED RELEASE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 50458-554 |
| Labeler Name: | Janssen Pharmaceuticals, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021999 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20090910 |
| Package NDC: | 50458-554-10 |
| Package Description: | 10 BLISTER PACK in 1 BOX, UNIT-DOSE (50458-554-10) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
| NDC Code | 50458-554-10 |
| Proprietary Name | INVEGA |
| Package Description | 10 BLISTER PACK in 1 BOX, UNIT-DOSE (50458-554-10) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
| Product NDC | 50458-554 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | paliperidone |
| Dosage Form Name | TABLET, EXTENDED RELEASE |
| Route Name | ORAL |
| Start Marketing Date | 20090910 |
| Marketing Category Name | NDA |
| Labeler Name | Janssen Pharmaceuticals, Inc. |
| Substance Name | PALIPERIDONE |
| Strength Number | 1.5 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Atypical Antipsychotic [EPC] |