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PREVNAR 13

These highlights do not include all the information needed to use PREVNAR 13 safely and effectively. See full prescribing information for PREVNAR 13. PREVNAR 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM Protein]) Suspension for intramuscular injection Initial U.S. Approval: 2010

Approved
Approval ID

e8c6b638-c22f-4c20-ba40-b9d5e85c9541

Product Type

VACCINE LABEL

Effective Date

Aug 22, 2018

Manufacturers
FDA

A-S Medication Solutions

DUNS: 830016429

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

pneumococcal 13-valent conjugate vaccine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50090-1944
Application NumberBLA125324
Product Classification
M
Marketing Category
C73585
G
Generic Name
pneumococcal 13-valent conjugate vaccine
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateAugust 29, 2017
FDA Product Classification

INGREDIENTS (15)

ALUMINUM PHOSPHATEInactive
Quantity: 125 ug in 0.5 mL
Code: F92V3S521O
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 6B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGENActive
Quantity: 4.4 ug in 0.5 mL
Code: 4M543JVT7G
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 9V CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGENActive
Quantity: 2.2 ug in 0.5 mL
Code: 5Q768OY0GI
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 18C CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGENActive
Quantity: 2.2 ug in 0.5 mL
Code: XK87D9J012
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 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
POLYSORBATE 80Inactive
Quantity: 100 ug in 0.5 mL
Code: 6OZP39ZG8H
Classification: IACT

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