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] |