: 4J9FJ0HL51)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:58160-829-01 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
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125614 10/20/2017
SHINGRIX
ge recombinant varicella zoster virus (vzv) glycoprotein e kit
PRODUCT INFORMATION
Product Type VACCINE Item Code (Source) NDC:58160-823
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:58160-823-11 1 in 1 CARTON; Type 0: Not a Combination Product
QUANTITY OF PARTS
Part # Package Quantity Total Product Quantity
Part 1 20 VIAL 10 mL
Part 2 20 VIAL 10 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: 4J9FJ0HL51)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:58160-829-01 0.5 mL in 1 VIAL; Type 0: Not a Combination Product
MARKETING INFORMATION
Marketing Category Application Numbe |
