MedPath
FDA Product

Prevnar 20

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Prevnar 20

0005-2000

Regulatory Information

0005-2000

BLA125731

C73585

April 18, 2025

USA

These highlights do not include all the information needed to use PREVNAR 20 safely and effectively. See full prescribing information for PREVNAR 20. PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine), suspension for intramuscular injection Initial U.S. Approval: 2021

VACCINE LABEL

9

Company Information

Wyeth Pharmaceutical Division of Wyeth Holdings LLC

054065909

Active Ingredients

POLYSORBATE 80

Quantity: 100 ug in 0.5 mL

Code: 6OZP39ZG8H

Class Code: IACT

ALUMINUM PHOSPHATE

Quantity: 125 ug in 0.5 mL

Code: F92V3S521O

Class Code: IACT

CORYNEBACTERIUM DIPHTHERIAE CRM197 PROTEIN

Quantity: 51 ug in 0.5 mL

Code: 08VC9WC084

Class Code: IACT

SUCCINATE DIANION

Quantity: 295 ug in 0.5 mL

Code: AJ326AG789

Class Code: IACT

SODIUM CHLORIDE

Quantity: 4.4 mg in 0.5 mL

Code: 451W47IQ8X

Class Code: IACT

Active Moieties

STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN

Code: 54EC0SE5PZ

STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN

Code: 2VF3V7175U

STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN

Code: TGJ6YZC4W7

STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN

Code: 5SKG37872O

STREPTOCOCCUS PNEUMONIAE TYPE 6A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN

Code: Z9HK08690W

STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN

Code: 4M543JVT7G

STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN

Code: 0K0S2P98ZJ

STREPTOCOCCUS PNEUMONIAE TYPE 8 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN

Code: ADR2S9OIF2

STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN

Code: 5Q768OY0GI

STREPTOCOCCUS PNEUMONIAE TYPE 10A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN

Code: N47C1SHV0F

STREPTOCOCCUS PNEUMONIAE TYPE 11A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN

Code: RDA5AKV23D

STREPTOCOCCUS PNEUMONIAE TYPE 12F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN

Code: T6O227OX7Q

STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN

Code: SK54I0S386

STREPTOCOCCUS PNEUMONIAE TYPE 15B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN

Code: H8Q6FRO6DY

STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN

Code: XK87D9J012

STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN

Code: B970MQT365

STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN

Code: 2E1M7F958B

STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN

Code: U1E9VSB2K2

STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN

Code: 25N8E57V6T

STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN

Code: 9WP2BC3I04

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