Package/Label Display Panel
C1 esterase inhibitor (recombinant)
For intravenous use only.
For single patient use.
See prescribing information for directions for use.
| RUCONEST c1 esterase inhibitor recombinant injection, powder, for solution |
|Product Information |
|Product Type ||HUMAN PRESCRIPTION DRUG ||Item Code (Source) ||NDC:68012-350 |
|Route of Administration ||INTRAVENOUS ||DEA Schedule || |
|Active Ingredient/Active Moiety |
|Ingredient Name ||Basis of Strength ||Strength |
|CONESTAT ALFA (CONESTAT ALFA) ||CONESTAT ALFA ||2100 U |
|Inactive Ingredients |
|Ingredient Name ||Strength |
| SUCROSE || |
| SODIUM CITRATE, UNSPECIFIED FORM || |
| CITRIC ACID MONOHYDRATE || |
|Product Characteristics |
|Color ||WHITE ||Score || |
|Shape || ||Size || |
|Flavor || ||Imprint Code || |
|Contains || |
|# ||Item Code ||Package Description ||Multilevel Packaging |
| 1 ||NDC:68012-350-02 ||1 VIAL, SINGLE-USE in 1 CARTON ||contains a VIAL, SINGLE-USE (68012-350-01) |
| 1 ||NDC:68012-350-01 ||1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE ||This package is contained within the CARTON (68012-350-02) |
| Marketing Information |
|Marketing Category ||Application Number or Monograph Citation ||Marketing Start Date ||Marketing End Date |
|BLA ||BLA125495 ||09/22/2014 ||01/18/2022 |
|Labeler — Santarus, Inc.
| Establishment |
|Name ||Address ||ID/FEI ||Operations |
|Bioconnection B.V. || ||414325873 ||MANUFACTURE (68012-350) |
Revised: 02/2015 Santarus, Inc.
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