NUCALA- mepolizumab injection, powder, for solution 
GlaxoSmithKline Manufacturing SpA

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PRINCIPAL DISPLAY PANEL

NDC 0173-0881-01

Nucala®

(mepolizumab)

for Injection

100 mg/vial

Rx Only

For subcutaneous injection after reconstitution.

Single-use vial. Discard unused portion.

Contents: Each vial delivers mepolizumab 100 mg, polysorbate 80 (0.67 mg), sodium phosphate dibasic heptahydrate (7.14 mg), and sucrose (160 mg). After reconstitution with 1.2 mL of Sterile Water for Injection, USP, the reconstituted solution concentration is 100 mg/mL and delivers 1 mL.

No preservative.

No U.S. standard of potency.

1 vial

Do not accept if plastic overseal is missing or not securely fitted.

©2016 the GSK group of companies

 
10000000141958 Rev. 6/16
Nucala 100 mg per vial carton
NUCALA 
mepolizumab injection, powder, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:12064-018
Route of AdministrationSUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MEPOLIZUMAB (UNII: 90Z2UF0E52) (MEPOLIZUMAB - UNII:90Z2UF0E52) MEPOLIZUMAB100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B)  
SUCROSE (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12064-018-001 in 1 CARTON11/04/2015
11 mL in 1 VIAL; Type 0: Not a Combination Product
2NDC:12064-018-011 in 1 CARTON06/17/2016
21 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractBLA12552611/04/2015
Labeler - GlaxoSmithKline Manufacturing SpA (338471078)

Revised: 12/2017
Document Id: ab3616d4-5124-4fb6-8f8e-8d408bcdd7fe
Set id: 4b7574ab-c677-4206-bdf3-9ced88fb09ff
Version: 3
Effective Time: 20171205
 
GlaxoSmithKline Manufacturing SpA