FDA.reportPublic FDA data

PNEUMOVAX 23

Product NDC
50090-7036
11-digit product format
500907036
Labeler code
50090
Product ID
50090-7036_6c0243f9-7f64-48a6-926f-1edd24a591c7
Type
VACCINE
Nonproprietary name
pneumococcal vaccine polyvalent
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; SUBCUTANEOUS
Labeler
A-S Medication Solutions
Application
BLA101094
Marketing category
BLA
Marketing start
2014-07-21
Substance
STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 10A CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 11A CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 12F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 15B CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 17F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 2 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 20 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 8 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 9N CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE ANTIGEN
Active strength
25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25 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; ug/.5mL; ug/.5mL; ug/.5mL
Pharmacologic classes
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], 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], 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], 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, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactiva...
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7036-0PNEUMOVAX 2310 in 1 CARTONINJECTION, SOLUTION104
50090-7036-1PNEUMOVAX 23.5 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION.54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7036-0ML - Milliliter50090-703635a74004-2b46-45b6-89bc-76a3369e9e4a12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7036PNEUMOVAX 23 (PNEUMOCOCCAL VACCINE POLYVALENT) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]2Current NDC, 2 package rows20240229_4c97c74d-b6b5-4492-b7ed-e02c76cc8514.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1547580pneumococcal 23-valent polysaccharide vaccine (PPSV23) 0.5 ML Prefilled SyringePSN4c97c74d-b6b5-4492-b7ed-e02c76cc85144
1547582PNEUMOVAX 23 vaccine 0.5 ML Prefilled SyringePSN4c97c74d-b6b5-4492-b7ed-e02c76cc85144
15475820.5 ML Streptococcus pneumoniae type 1 capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 10A capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 11A capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 12F capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 14 capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 15B capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 17F capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 18C capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 19A capsular polysaccharide antigeSBD4c97c74d-b6b5-4492-b7ed-e02c76cc85144
15475800.5 ML Streptococcus pneumoniae type 1 capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 10A capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 11A capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 12F capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 14 capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 15B capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 17F capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 18C capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 19A capsular polysaccharide antigeSCD4c97c74d-b6b5-4492-b7ed-e02c76cc85144
1547580pneumococcal vaccine 23-polyvalent 0.5 ML Prefilled SyringeSY4c97c74d-b6b5-4492-b7ed-e02c76cc85144
1547582Pneumovax 23 (Pneumococcal vaccine polyvalent) 0.5 ML Prefilled SyringeSY4c97c74d-b6b5-4492-b7ed-e02c76cc85144

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7036-05009070360010 SYRINGE, GLASS in 1 CARTON (50090-7036-0) / .5 mL in 1 SYRINGE, GLASS (50090-7036-1) 2014-07-21NoNoHistorical
50090-7036-150090703601.5 mL in 1 SYRINGE, GLASSHistorical