| Product NDC: | 50458-562 |
| Proprietary Name: | INVEGA SUSTENNA |
| Non Proprietary Name: | paliperidone palmitate |
| Active Ingredient(s): | 117 mg/.75mL & nbsp; paliperidone palmitate |
| Administration Route(s): | INTRAMUSCULAR |
| Dosage Form(s): | INJECTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 50458-562 |
| Labeler Name: | Janssen Pharmaceuticals, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA022264 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20090731 |
| Package NDC: | 50458-562-01 |
| Package Description: | 1 SYRINGE in 1 KIT (50458-562-01) > .75 mL in 1 SYRINGE |
| NDC Code | 50458-562-01 |
| Proprietary Name | INVEGA SUSTENNA |
| Package Description | 1 SYRINGE in 1 KIT (50458-562-01) > .75 mL in 1 SYRINGE |
| Product NDC | 50458-562 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | paliperidone palmitate |
| Dosage Form Name | INJECTION |
| Route Name | INTRAMUSCULAR |
| Start Marketing Date | 20090731 |
| Marketing Category Name | NDA |
| Labeler Name | Janssen Pharmaceuticals, Inc. |
| Substance Name | PALIPERIDONE PALMITATE |
| Strength Number | 117 |
| Strength Unit | mg/.75mL |
| Pharmaceutical Classes | Atypical Antipsychotic [EPC] |