Prevnar 20
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
Approved
Approval ID
d4e2cf51-e6a8-4103-bb1d-6120c6474ff8
Product Type
VACCINE LABEL
Effective Date
Apr 18, 2025
Manufacturers
FDA
Wyeth Pharmaceutical Division of Wyeth Holdings LLC
DUNS: 054065909
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Pneumococcal 20-valent Conjugate Vaccine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0005-2000
Application NumberBLA125731
Product Classification
M
Marketing Category
C73585
G
Generic Name
Pneumococcal 20-valent Conjugate Vaccine
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateApril 18, 2025
FDA Product Classification
INGREDIENTS (25)
POLYSORBATE 80Inactive
Quantity: 100 ug in 0.5 mL
Code: 6OZP39ZG8H
Classification: IACT
STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGENActive
Quantity: 2.2 ug in 0.5 mL
Code: 54EC0SE5PZ
Classification: ACTIB
STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGENActive
Quantity: 2.2 ug in 0.5 mL
Code: 2VF3V7175U
Classification: ACTIB
STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGENActive
Quantity: 2.2 ug in 0.5 mL
Code: TGJ6YZC4W7
Classification: ACTIB
STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGENActive
Quantity: 2.2 ug in 0.5 mL
Code: 5SKG37872O
Classification: ACTIB
STREPTOCOCCUS PNEUMONIAE TYPE 6A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGENActive
Quantity: 2.2 ug in 0.5 mL
Code: Z9HK08690W
Classification: ACTIB
STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGENActive
Quantity: 2.2 ug in 0.5 mL
Code: 0K0S2P98ZJ
Classification: ACTIB
STREPTOCOCCUS PNEUMONIAE TYPE 8 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGENActive
Quantity: 2.2 ug in 0.5 mL
Code: ADR2S9OIF2
Classification: ACTIB
STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGENActive
Quantity: 2.2 ug in 0.5 mL
Code: 5Q768OY0GI
Classification: ACTIB
STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGENActive
Quantity: 4.4 ug in 0.5 mL
Code: 4M543JVT7G
Classification: ACTIB
STREPTOCOCCUS PNEUMONIAE TYPE 10A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGENActive
Quantity: 2.2 ug in 0.5 mL
Code: N47C1SHV0F
Classification: ACTIB
STREPTOCOCCUS PNEUMONIAE TYPE 11A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGENActive
Quantity: 2.2 ug in 0.5 mL
Code: RDA5AKV23D
Classification: ACTIB
STREPTOCOCCUS PNEUMONIAE TYPE 12F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGENActive
Quantity: 2.2 ug in 0.5 mL
Code: T6O227OX7Q
Classification: ACTIB
STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGENActive
Quantity: 2.2 ug in 0.5 mL
Code: SK54I0S386
Classification: ACTIB
STREPTOCOCCUS PNEUMONIAE TYPE 15B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGENActive
Quantity: 2.2 ug in 0.5 mL
Code: H8Q6FRO6DY
Classification: ACTIB
STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGENActive
Quantity: 2.2 ug in 0.5 mL
Code: XK87D9J012
Classification: ACTIB
STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGENActive
Quantity: 2.2 ug in 0.5 mL
Code: B970MQT365
Classification: ACTIB
STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGENActive
Quantity: 2.2 ug in 0.5 mL
Code: 2E1M7F958B
Classification: ACTIB
STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGENActive
Quantity: 2.2 ug in 0.5 mL
Code: U1E9VSB2K2
Classification: ACTIB
STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGENActive
Quantity: 2.2 ug in 0.5 mL
Code: 25N8E57V6T
Classification: ACTIB
STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGENActive
Quantity: 2.2 ug in 0.5 mL
Code: 9WP2BC3I04
Classification: ACTIB
ALUMINUM PHOSPHATEInactive
Quantity: 125 ug in 0.5 mL
Code: F92V3S521O
Classification: IACT
CORYNEBACTERIUM DIPHTHERIAE CRM197 PROTEINInactive
Quantity: 51 ug in 0.5 mL
Code: 08VC9WC084
Classification: IACT
SUCCINATE DIANIONInactive
Quantity: 295 ug in 0.5 mL
Code: AJ326AG789
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 4.4 mg in 0.5 mL
Code: 451W47IQ8X
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 4/28/2023
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 4/28/2023
CONTRAINDICATIONS SECTION
LOINC: 34070-3Updated: 4/28/2023
WARNINGS AND PRECAUTIONS SECTION
LOINC: 43685-7Updated: 4/28/2023
ADVERSE REACTIONS SECTION
LOINC: 34084-4Updated: 4/28/2023
DRUG INTERACTIONS SECTION
LOINC: 34073-7Updated: 4/28/2023
RECENT MAJOR CHANGES SECTION
LOINC: 43683-2Updated: 4/28/2023
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 4/28/2023
DOSAGE FORMS & STRENGTHS SECTION
LOINC: 43678-2Updated: 4/28/2023
USE IN SPECIFIC POPULATIONS SECTION
LOINC: 43684-0Updated: 4/28/2023
DESCRIPTION SECTION
LOINC: 34089-3Updated: 4/28/2023
CLINICAL PHARMACOLOGY SECTION
LOINC: 34090-1Updated: 4/28/2023
NONCLINICAL TOXICOLOGY SECTION
LOINC: 43680-8Updated: 4/28/2023
CLINICAL STUDIES SECTION
LOINC: 34092-7Updated: 4/28/2023
HOW SUPPLIED SECTION
LOINC: 34069-5Updated: 4/28/2023
INFORMATION FOR PATIENTS SECTION
LOINC: 34076-0Updated: 4/28/2023
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 4/28/2023