NDC 50090-6026

PREVNAR 20

Pneumococcal 20-valent Conjugate Vaccine

PREVNAR 20 is a Intramuscular Injection, Suspension in the Vaccine category. It is labeled and distributed by A-s Medication Solutions. The primary component is Streptococcus Pneumoniae Type 1 Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 10a Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 11a Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 12f Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 14 Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 15b Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 18c Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 19a Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 19f Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 22f Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 23f Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 3 Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 33f Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 4 Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 5 Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 6a Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 6b Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 7f Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 8 Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 9v Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen.

Product ID50090-6026_0423f9e2-c031-47a5-95d5-08ce23200c01
NDC50090-6026
Product TypeVaccine
Proprietary NamePREVNAR 20
Generic NamePneumococcal 20-valent Conjugate Vaccine
Dosage FormInjection, Suspension
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2021-08-10
Marketing CategoryBLA /
Application NumberBLA125731
Labeler NameA-S Medication Solutions
Substance NameSTREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 10A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 11A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 12F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 15B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 6A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 8 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN
Active Ingredient Strength2 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL
Pharm ClassesActively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Vaccines, Conjugate [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 50090-6026-0

10 SYRINGE in 1 CARTON (50090-6026-0) > .5 mL in 1 SYRINGE (50090-6026-1)
Marketing Start Date2021-08-10
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "PREVNAR 20" or generic name "Pneumococcal 20-valent Conjugate Vaccine"

NDCBrand NameGeneric Name
0005-2000Prevnar 20Pneumococcal 20-valent Conjugate Vaccine
50090-6026PREVNAR 20Pneumococcal 20-valent Conjugate Vaccine

Trademark Results [PREVNAR 20]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PREVNAR 20
PREVNAR 20
90458834 not registered Live/Pending
Wyeth LLC
2021-01-11
PREVNAR 20
PREVNAR 20
88293753 not registered Live/Pending
WYETH LLC
2019-02-08

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.