| Product NDC: | 0270-1111 |
| Proprietary Name: | ProHance |
| Non Proprietary Name: | gadoteridol |
| Active Ingredient(s): | 279.3 mg/mL & nbsp; gadoteridol |
| Administration Route(s): | INTRAVENOUS |
| Dosage Form(s): | INJECTION, SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0270-1111 |
| Labeler Name: | Bracco Diagnostics Inc |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021489 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20031009 |
| Package NDC: | 0270-1111-02 |
| Package Description: | 5 VIAL, SINGLE-DOSE in 1 BOX (0270-1111-02) > 15 mL in 1 VIAL, SINGLE-DOSE |
| NDC Code | 0270-1111-02 |
| Proprietary Name | ProHance |
| Package Description | 5 VIAL, SINGLE-DOSE in 1 BOX (0270-1111-02) > 15 mL in 1 VIAL, SINGLE-DOSE |
| Product NDC | 0270-1111 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | gadoteridol |
| Dosage Form Name | INJECTION, SOLUTION |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 20031009 |
| Marketing Category Name | NDA |
| Labeler Name | Bracco Diagnostics Inc |
| Substance Name | GADOTERIDOL |
| Strength Number | 279.3 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC] |