| Product NDC: | 52584-411 |
| Proprietary Name: | ISOVUE-M 200 |
| Non Proprietary Name: | Iopamidol |
| Active Ingredient(s): | 408 mg/mL & nbsp; Iopamidol |
| Administration Route(s): | INTRATHECAL |
| Dosage Form(s): | INJECTION, SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 52584-411 |
| Labeler Name: | General Injectables & Vaccines, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA018735 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20101105 |
| Package NDC: | 52584-411-11 |
| Package Description: | 1 VIAL, SINGLE-DOSE in 1 BAG (52584-411-11) > 10 mL in 1 VIAL, SINGLE-DOSE |
| NDC Code | 52584-411-11 |
| Proprietary Name | ISOVUE-M 200 |
| Package Description | 1 VIAL, SINGLE-DOSE in 1 BAG (52584-411-11) > 10 mL in 1 VIAL, SINGLE-DOSE |
| Product NDC | 52584-411 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Iopamidol |
| Dosage Form Name | INJECTION, SOLUTION |
| Route Name | INTRATHECAL |
| Start Marketing Date | 20101105 |
| Marketing Category Name | NDA |
| Labeler Name | General Injectables & Vaccines, Inc. |
| Substance Name | IOPAMIDOL |
| Strength Number | 408 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] |