Ruconest (Page 5 of 5)

Package/Label Display Panel

RUCONEST®

C1 esterase inhibitor (recombinant)

2100 U

NDC 68012-350-01

For intravenous use only.

For single patient use.

See prescribing information for directions for use.

Rx only

labels
(click image for full-size original)
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
Packaging
# 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. (104286369)
Establishment
Name Address ID/FEI Operations
Bioconnection B.V. 414325873 MANUFACTURE (68012-350)

Revised: 02/2015 Santarus, Inc.

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