| Product NDC: | 57894-071 |
| Proprietary Name: | Simponi |
| Non Proprietary Name: | golimumab |
| Active Ingredient(s): | 100 mg/mL & nbsp; golimumab |
| Administration Route(s): | SUBCUTANEOUS |
| Dosage Form(s): | INJECTION, SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 57894-071 |
| Labeler Name: | Janssen Biotech, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | BLA125289 |
| Marketing Category: | BLA |
| Start Marketing Date: | 20130515 |
| Package NDC: | 57894-071-90 |
| Package Description: | 1 SYRINGE, GLASS in 1 CARTON (57894-071-90) > 1 mL in 1 SYRINGE, GLASS |
| NDC Code | 57894-071-90 |
| Proprietary Name | Simponi |
| Package Description | 1 SYRINGE, GLASS in 1 CARTON (57894-071-90) > 1 mL in 1 SYRINGE, GLASS |
| Product NDC | 57894-071 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | golimumab |
| Dosage Form Name | INJECTION, SOLUTION |
| Route Name | SUBCUTANEOUS |
| Start Marketing Date | 20130515 |
| Marketing Category Name | BLA |
| Labeler Name | Janssen Biotech, Inc. |
| Substance Name | GOLIMUMAB |
| Strength Number | 100 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Tumor Necrosis Factor Blocker [EPC] |