NDC Code(s) : 0002-7669-01, 0002-7678-01
Packager : Eli Lilly and Company

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CYRAMZA ramucirumab SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0002-7669
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ramucirumab(UNII: D99YVK4L0X)
(ramucirumab - UNII:D99YVK4L0X) 		ramucirumab10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
histidine(UNII: 4QD397987E)0.65 mg in 1 mL
histidine monohydrochloride(UNII: 1D5Q932XM6)1.22 mg in 1 mL
sodium chloride(UNII: 451W47IQ8X)4.38 mg in 1 mL
glycine(UNII: TE7660XO1C)9.98 mg in 1 mL
polysorbate 80(UNII: 6OZP39ZG8H)0.1 mg in 1 mL
water(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0002-7669-011 in 1 CARTON 21/04/2014
110 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125477 04/21/2014
CYRAMZA ramucirumab SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0002-7678
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ramucirumab(UNII: D99YVK4L0X)
(ramucirumab - UNII:D99YVK4L0X) 		ramucirumab10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
histidine(UNII: 4QD397987E)0.65 mg in 1 mL
histidine monohydrochloride(UNII: 1D5Q932XM6)1.22 mg in 1 mL
sodium chloride(UNII: 451W47IQ8X)4.38 mg in 1 mL
glycine(UNII: TE7660XO1C)9.98 mg in 1 mL
polysorbate 80(UNII: 6OZP39ZG8H)0.1 mg in 1 mL
water(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0002-7678-011 in 1 CARTON 21/04/2014
150 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125477 04/21/2014

LABELER - Eli Lilly and Company(006421325)

PRINCIPAL DISPLAY PANEL

PACKAGE LABELING

This section contains a representative sample of product package labeling. Product may be manufactured at other manufacturing sites.

PACKAGE CARTON –CYRAMZA 100 mg/10 mL single-use vial.

NDC 0002-7669-01

Cyramza®

(ramucirumab)

Injection

100 mg/10 mL

(10 mg/mL)

For Intravenous Infusion Only

Must Dilute Prior to Use

Single-Dose Vial

Discard Unused Portion

Keep Refrigerated

Rx only

www.cyramza.com

Lilly

CARTON FOR US ORIGIN

CARTON FOR IRELAND ORIGIN

PRINCIPAL DISPLAY PANEL

PACKAGE CARTON – CYRAMZA 500 mg/50mL single-use vial.

NDC 0002-7678-01

Cyramza®

(ramucirumab)

Injection

500 mg/50 mL

(10 mg/mL)

For Intravenous Infusion Only

Must Dilute Prior to Use

Single-Dose Vial

Discard Unused Portion

Keep Refrigerated

Rx only

www.cyramza.com

Lilly

CARTON FOR US ORIGIN

PACKAGE CARTON – CYRAMZA 100 mg/10 mL single-use vial

CARTON FOR IRELAND ORIGIN

PACKAGE CARTON – CYRAMZA 100 mg/10 mL single-use vial