Vaccine Information: Prevnar 20 (Page 4 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

Pre-filled Syringe, 1 Dose (10 per package) – NDC 0005-2000-10.

Pre-filled Syringe, 1 Dose (1 per package) – NDC 0005-2000-02.

After shipping, Prevnar 20 may arrive at temperatures between 2 ºC to 25 ºC (36 ºF to 77 ºF).

Upon receipt, store refrigerated at 2 ºC to 8 ºC (36 ºF to 46 ºF).

Syringes should be stored in the refrigerator horizontally to minimize the resuspension time.

Do not freeze. Discard if the vaccine has been frozen.

Prevnar 20 should be administered as soon as possible after being removed from refrigeration.

Prevnar 20 can be administered provided total (cumulative multiple excursions) time out of refrigeration (at temperatures between 8 °C and 25 °C) does not exceed 96 hours. Cumulative multiple excursions between 0 °C and 2 °C are also permitted as long as the total time between 0 °C and 2 °C does not exceed 72 hours. These are not, however, recommendations for storage.

The tip cap and plunger stopper of the pre-filled syringe are not made with natural rubber latex.

17 PATIENT COUNSELING INFORMATION

Prior to administration of this vaccine, inform the individual of the following:

This product’s labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

Logo
(click image for full-size original)

US Govt. License No. 3

LAB-1436-1.0

CPT Code 90677

PRINCIPAL DISPLAY PANEL — 0.5 mL Syringe Label

NDC 0005-2000-01
Rx only

Pneumococcal 20-valent
Conjugate Vaccine
Prevnar 20™

One Dose (0.5 mL)
FOR IM USE ONLY

REFRIGERATE
DO NOT FREEZE
SHAKE WELL

Wyeth Pharm. LLC US Govt. License No. 3

PAA167474

LOT: XXXXXX

EXP: XXXXXX

PRINCIPAL DISPLAY PANEL -- 0.5 mL Syringe Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.5 mL Syringe Carton — 0005-2000-10

Pfizer
NDC 0005-2000-10

Pneumococcal 20-valent Conjugate Vaccine

PREVNAR 20™

FOR USE IN INDIVIDUALS 18 YEARS OFAGE AND OLDER

FOR INTRAMUSCULAR USE ONLY

10 One-Dose (0.5 mL) Disposable Syringes

Rx only

PRINCIPAL DISPLAY PANEL -- 0.5 mL Syringe Carton -- 0005-2000-10
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.5 mL Syringe Carton — 0005-2000-02

Pfizer
NDC 0005-2000-02

Pneumococcal 20-valent Conjugate Vaccine

PREVNAR 20™

FOR USE IN INDIVIDUALS 18 YEARS OF AGE AND OLDER

FOR INTRAMUSCULAR USE ONLY

One-Dose (0.5 mL) Disposable SyringeRx only

PRINCIPAL DISPLAY PANEL -- 0.5 mL Syringe Carton -- 0005-2000-02
(click image for full-size original)
PREVNAR 20 pneumococcal 20-valent conjugate vaccine injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:0005-2000
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 6A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 6A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 6A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 4.4 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 8 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 8 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 8 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 10A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 10A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 10A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 11A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 11A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 11A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 12F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 12F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 12F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 15B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 15B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 15B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
POLYSORBATE 80 100 ug in 0.5 mL
ALUMINUM PHOSPHATE 125 ug in 0.5 mL
CORYNEBACTERIUM DIPHTHERIAE CRM197 PROTEIN 51 ug in 0.5 mL
SUCCINATE DIANION 295 ug in 0.5 mL
SODIUM CHLORIDE 4.4 mg in 0.5 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0005-2000-10 10 SYRINGE in 1 CARTON contains a SYRINGE (0005-2000-01)
1 NDC:0005-2000-01 0.5 mL in 1 SYRINGE This package is contained within the CARTON (0005-2000-10)
2 NDC:0005-2000-02 1 SYRINGE in 1 CARTON contains a SYRINGE (0005-2000-01)
2 NDC:0005-2000-01 0.5 mL in 1 SYRINGE This package is contained within the CARTON (0005-2000-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125731 08/10/2021
Labeler — Wyeth Pharmaceutical Division of Wyeth Holdings LLC (054065909)
Establishment
Name Address ID/FEI Operations
Pfizer Ireland Pharmaceuticals 985586408 ANALYSIS (0005-2000), MANUFACTURE (0005-2000), API MANUFACTURE (0005-2000)
Establishment
Name Address ID/FEI Operations
Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC 174350868 ANALYSIS (0005-2000), API MANUFACTURE (0005-2000)
Establishment
Name Address ID/FEI Operations
Wyeth Pharmaceutical Division of Wyeth Holdings LLC 883534067 ANALYSIS (0005-2000), API MANUFACTURE (0005-2000)
Establishment
Name Address ID/FEI Operations
Pfizer Manufacturing Belgium NV 370156507 PACK (0005-2000), LABEL (0005-2000)
Establishment
Name Address ID/FEI Operations
Pfizer Inc 004954111 MANUFACTURE (0005-2000)

Revised: 08/2021 Wyeth Pharmaceutical Division of Wyeth Holdings LLC

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