Vaccine Information: YF-VAX (Page 4 of 4)

PRINCIPAL DISPLAY PANEL — 0.5 mL Vial Label

NDC 49281-915-58
Yellow Fever
Vaccine
YF-VAX^®

YF

single-dose (0.5 mL)

Rx only

Mfd by: Sanofi Pasteur Inc.

YF-VAX^®

NDC 49281-915-58

Rx only

Mfd by: Sanofi Pasteur Inc.

(L)

7501

PRINCIPAL DISPLAY PANEL — 5 Vial Package

NDC 49281-915-01

5 single-dose vials

YF

Yellow Fever Vaccine
YF-VAX^®

(live 17D virus, freeze-dried, avian leukosis-free, sorbitol-gelatin stabilized)

Rx only

SANOFI PASTEUR

PRINCIPAL DISPLAY PANEL — 0.6 mL Vial Label

NDC 49281-912-59
NaCl

Sodium
Chloride
Injection USP

single-dose
0.6 mL
Rx only

For reconstitution of
1 Dose Yellow Fever
Vaccine only

Mfd by: Sanofi Pasteur Inc. Swiftwater PA 18370 USA

7503

PRINCIPAL DISPLAY PANEL — 5 Vial Package

NDC 49281-912-05 NaCl

5 single-dose vials
(0.6 mL each)

Sodium Chloride
Injection USP

Diluent for single-doseYellow Fever Vaccine

Rx only

SANOFI PASTEUR

YF-VAX yellow fever virus strain 17d-204 live antigen injection, powder, lyophilized, for suspension

Product Information Product Type VACCINE Item Code (Source) NDC:49281-915 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength YELLOW FEVER VIRUS STRAIN 17D-204 LIVE ANTIGEN (YELLOW FEVER VIRUS STRAIN 17D-204 LIVE ANTIGEN) YELLOW FEVER VIRUS STRAIN 17D-204 LIVE ANTIGEN 4.74 [PFU] in 0.5 mL

Inactive Ingredients Ingredient Name Strength SORBITOL GELATIN, UNSPECIFIED

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:49281-915-01 5 VIAL, SINGLE-DOSE in 1 PACKAGE contains a VIAL, SINGLE-DOSE (49281-915-58) 1 NDC:49281-915-58 0.5 mL in 1 VIAL, SINGLE-DOSE This package is contained within the PACKAGE (49281-915-01) 2 NDC:49281-915-05 1 VIAL, MULTI-DOSE in 1 PACKAGE contains a VIAL, MULTI-DOSE (49281-915-68) 2 NDC:49281-915-68 2.5 mL in 1 VIAL, MULTI-DOSE This package is contained within the PACKAGE (49281-915-05)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103915 05/22/1953

DILUENT sodium chloride injection

Product Information Product Type VACCINE Item Code (Source) NDC:49281-912 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 4.5 mg in 0.5 mL

Inactive Ingredients Ingredient Name Strength WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:49281-912-05 5 VIAL, SINGLE-DOSE in 1 PACKAGE contains a VIAL, SINGLE-DOSE (49281-912-59) 1 NDC:49281-912-59 0.6 mL in 1 VIAL, SINGLE-DOSE This package is contained within the PACKAGE (49281-912-05) 2 NDC:49281-912-10 1 VIAL, MULTI-DOSE in 1 PACKAGE contains a VIAL, MULTI-DOSE (49281-912-69) 2 NDC:49281-912-69 3 mL in 1 VIAL, MULTI-DOSE This package is contained within the PACKAGE (49281-912-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103915 05/22/1953

Labeler — Sanofi Pasteur Inc. (086723285)

Establishment
Name	Address	ID/FEI	Operations
Sanofi Pasteur Inc.		086723285	MANUFACTURE

Revised: 02/2021 Sanofi Pasteur Inc.