Product NDC: | 52584-911 |
Proprietary Name: | Romazicon |
Non Proprietary Name: | Flumazenil |
Active Ingredient(s): | .1 mg/mL & nbsp; Flumazenil |
Administration Route(s): | INTRAVENOUS |
Dosage Form(s): | INJECTION, SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 52584-911 |
Labeler Name: | General Injectables & Vaccines, Inc |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA020073 |
Marketing Category: | NDA |
Start Marketing Date: | 20100901 |
Package NDC: | 52584-911-06 |
Package Description: | 1 VIAL, MULTI-DOSE in 1 BAG (52584-911-06) > 5 mL in 1 VIAL, MULTI-DOSE |
NDC Code | 52584-911-06 |
Proprietary Name | Romazicon |
Package Description | 1 VIAL, MULTI-DOSE in 1 BAG (52584-911-06) > 5 mL in 1 VIAL, MULTI-DOSE |
Product NDC | 52584-911 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Flumazenil |
Dosage Form Name | INJECTION, SOLUTION |
Route Name | INTRAVENOUS |
Start Marketing Date | 20100901 |
Marketing Category Name | NDA |
Labeler Name | General Injectables & Vaccines, Inc |
Substance Name | FLUMAZENIL |
Strength Number | .1 |
Strength Unit | mg/mL |
Pharmaceutical Classes | Benzodiazepine Antagonist [EPC] |