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: | 0270-1111-70 |
Package Description: | 5 VIAL, PHARMACY BULK PACKAGE in 1 BOX (0270-1111-70) > 50 mL in 1 VIAL, PHARMACY BULK PACKAGE |
NDC Code | 0270-1111-70 |
Proprietary Name | ProHance |
Package Description | 5 VIAL, PHARMACY BULK PACKAGE in 1 BOX (0270-1111-70) > 50 mL in 1 VIAL, PHARMACY BULK PACKAGE |
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] |