Product NDC: | 67684-5505 |
Proprietary Name: | HEXABRIX |
Non Proprietary Name: | ioxaglate meglumine and ioxaglate sodium |
Active Ingredient(s): | 393; 196 mg/mL; mg/mL & nbsp; ioxaglate meglumine and ioxaglate sodium |
Administration Route(s): | INTRAVASCULAR |
Dosage Form(s): | INJECTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 67684-5505 |
Labeler Name: | Guerbet LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA018905 |
Marketing Category: | NDA |
Start Marketing Date: | 20090409 |
Package NDC: | 67684-5505-2 |
Package Description: | 25 VIAL, GLASS in 1 CASE (67684-5505-2) > 50 mL in 1 VIAL, GLASS |
NDC Code | 67684-5505-2 |
Proprietary Name | HEXABRIX |
Package Description | 25 VIAL, GLASS in 1 CASE (67684-5505-2) > 50 mL in 1 VIAL, GLASS |
Product NDC | 67684-5505 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | ioxaglate meglumine and ioxaglate sodium |
Dosage Form Name | INJECTION |
Route Name | INTRAVASCULAR |
Start Marketing Date | 20090409 |
Marketing Category Name | NDA |
Labeler Name | Guerbet LLC |
Substance Name | IOXAGLATE MEGLUMINE; IOXAGLATE SODIUM |
Strength Number | 393; 196 |
Strength Unit | mg/mL; mg/mL |
Pharmaceutical Classes | Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA],Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] |