NDC Code(s) : 12064-018-00, 12064-018-01
Packager : GlaxoSmithKline Manufacturing SpA

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Nucalamepolizumab INJECTION, POWDER, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:12064-018
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEPOLIZUMAB(UNII: 90Z2UF0E52)
(MEPOLIZUMAB - UNII:90Z2UF0E52) 		MEPOLIZUMAB100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
POLYSORBATE 80(UNII: 6OZP39ZG8H)
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE(UNII: 70WT22SF4B)
SUCROSE(UNII: C151H8M554)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:12064-018-001 in 1 CARTON 04/11/2015
11 mL in 1 VIAL Type 0: Not a Combination Product
2NDC:12064-018-011 in 1 CARTON 17/06/2016
21 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Approved Drug Product Manufactured Under Contract BLA125526 11/04/2015

PRINCIPAL DISPLAY PANEL

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