-01
490627 Rev. 10/17
Shingrix 1 count Adjuvant vial label
PRINCIPAL DISPLAY PANEL
One Count Antigen Vial Label
NDC 58160-828-01
490628 Rev. 10/17
Shingirx 1 count Antigen vial label
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
NDC 58160-823-11
SHINGRIX
Zoster Vaccine Recombinant, Adjuvanted
Contents (10 doses of SHINGRIX):
10 Vials containing Lyophilized gE Antigen Component
10 Vials containing Adjuvant Suspension Component
After reconstitution, a single dose of SHINGRIX is 0.5 mL
For 50 Years of Age and Older
Trademark is owned by or licensed to the GSK group of companies.
Antigen and Adjuvant Made in Belgium
©2017 GSK group of companies or its licensor.
490734 Rev. 10/17
Shingrix 10 count carton
PRINCIPAL DISPLAY PANEL
10 Count Adjuvant Vial Label
NDC 58160-829-03
490658 Rev. 10/17
Shingrix 10 count adjuvant vial label
PRINCIPAL DISPLAY PANEL
10 Count Antigen Vial Label
NDC 58160-828-03
490735 Rev. 10/17
Shingrix 10 count antigen vial label
INGREDIENTS AND APPEARANCE
SHINGRIX
ge recombinant varicella zoster virus (vzv) glycoprotein e kit
PRODUCT INFORMATION
Product Type VACCINE Item Code (Source) NDC:58160-819
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:58160-819-12 1 in 1 CARTON; Type 0: Not a Combination Product
QUANTITY OF PARTS
Part # Package Quantity Total Product Quantity
Part 1 2 VIAL 1 mL
Part 2 2 VIAL 1 mL
Part 1 of 2
SHINGRIX
ge recombinant varicella zoster virus (vzv) glycoprotein e injection, powder, lyophilized, for suspension
PRODUCT INFORMATION
Item Code (Source) NDC:58160-828
Route of Administration INTRAMUSCULAR
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
gE: Recombinant Varicella Zoster Virus (VZV) glycoprotein E (UNII: COB9FF6I46) (gE: Recombinant Varicella Zoster Virus (VZV) glycoprotein E - UNII:COB9FF6I46) gE: Recombinant Varicella Zoster Virus (VZV) glycoprotein E 50 ug in 0.5 mL
INACTIVE INGREDIENTS
Ingredient Name Strength
SUCROSE (UNII: C151H8M554)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)
POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z)
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:58160-828-01 0.5 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
BLA BLA125614 10/20/2017
Part 2 of 2
AS01B
as01b suspension
PRODUCT INFORMATION
Item Code (Source) NDC:58160-829
Route of Administration INTRAMUSCULAR
INACTIVE INGREDIENTS
Ingredient Name Strength
MONOPHOSPHORYL LIPID A (UNII: MWC0ET1L2P)
QS-21 (UNII: 61H83WZX3U)
DIOLEOYLPHOSPHATIDYLCHOLINE, DL- (UNII: EDS2L3ODLV)
CHOLESTEROL (UNII: 97C5T2UQ7J)
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)
POTASSIUM PHOSPHATE, MONOBASIC (UNII |
