Ultomiris: Package Insert and Label Information (Page 7 of 7)

PRINCIPAL DISPLAY PANEL — 30 mL Vial Carton

NDC 25682-022-01

ULTOMIRIS®
(ravulizumab-cwvz)
injection

300 mg/30 mL
(10 mg/mL)

For Intravenous Infusion

Dilute with 0.9% Sodium Chloride
Injection prior to use.

Rx only

30 mL Single-dose vial

Discard Unused Portion

Attention: Dispense the enclosed Medication Guide to each patient.

PRINCIPAL DISPLAY PANEL -- 30 mL Vial Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 3 mL Vial Carton

Rx only

NEW CONCENTRATION
NDC 25682-025-01

ULTOMIRIS®
(ravulizumab-cwvz)
Injection

300 mg/3 mL
(100 mg/mL)

For Intravenous Infusion

Dilute with 0.9 % Sodium Chloride
Injection prior to use.

3 mL Single-dose vial

Discard Unused Portion

Attention: Dispense the enclosed Medication Guide to each patient.

PRINCIPAL DISPLAY PANEL -- 3 mL Vial Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 11 mL Vial Carton

Rx only

NEW CONCENTRATION
NDC 25682-028-01

ULTOMIRIS®
(ravulizumab-cwvz)
Injection

1,100 mg/11mL
(100 mg/mL)

For Intravenous Infusion

Dilute with 0.9 % Sodium Chloride
Injection prior to use.

11 mL Single-dose vial

Discard Unused Portion

Attention: Dispense the enclosedMedication Guide to each patient.

PRINCIPAL DISPLAY PANEL -- 11 mL Vial Carton
(click image for full-size original)
ULTOMIRIS ravulizumab solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25682-022
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ravulizumab (ravulizumab) ravulizumab 300 mg in 30 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:25682-022-01 1 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS
1 30 mL in 1 VIAL, GLASS This package is contained within the CARTON (25682-022-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761108 12/21/2018
ULTOMIRIS ravulizumab solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25682-025
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ravulizumab (ravulizumab) ravulizumab 300 mg in 3 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:25682-025-01 1 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS
1 3 mL in 1 VIAL, GLASS This package is contained within the CARTON (25682-025-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761108 12/21/2018
ULTOMIRIS ravulizumab solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25682-028
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ravulizumab (ravulizumab) ravulizumab 1100 mg in 11 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:25682-028-01 1 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS
1 11 mL in 1 VIAL, GLASS This package is contained within the CARTON (25682-028-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761108 12/21/2018
Labeler — Alexion Pharmaceuticals Inc. (789359510)

Revised: 05/2022 Alexion Pharmaceuticals Inc.

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