Product NDC: | 42227-081 |
Proprietary Name: | Cinryze |
Non Proprietary Name: | HUMAN C1-ESTERASE INHIBITOR |
Active Ingredient(s): | 500 [iU]/5mL & nbsp; HUMAN C1-ESTERASE INHIBITOR |
Administration Route(s): | INTRAVENOUS |
Dosage Form(s): | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 42227-081 |
Labeler Name: | ViroPharma Biologics |
Product Type: | PLASMA DERIVATIVE |
FDA Application Number: | BLA125267 |
Marketing Category: | BLA |
Start Marketing Date: | 20081201 |
Package NDC: | 42227-081-05 |
Package Description: | 1 VIAL, SINGLE-USE in 1 CARTON (42227-081-05) > 5 mL in 1 VIAL, SINGLE-USE |
NDC Code | 42227-081-05 |
Proprietary Name | Cinryze |
Package Description | 1 VIAL, SINGLE-USE in 1 CARTON (42227-081-05) > 5 mL in 1 VIAL, SINGLE-USE |
Product NDC | 42227-081 |
Product Type Name | PLASMA DERIVATIVE |
Non Proprietary Name | HUMAN C1-ESTERASE INHIBITOR |
Dosage Form Name | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Route Name | INTRAVENOUS |
Start Marketing Date | 20081201 |
Marketing Category Name | BLA |
Labeler Name | ViroPharma Biologics |
Substance Name | HUMAN C1-ESTERASE INHIBITOR |
Strength Number | 500 |
Strength Unit | [iU]/5mL |
Pharmaceutical Classes | Human C1 Esterase Inhibitor [EPC],Decreased Vascular Permeability [PE],Kallikrein Inhibitors [MoA] |