FDA.reportPublic FDA data

PNEUMOVAX 23

Product NDC
50090-1452
11-digit product format
500901452
Labeler code
50090
Product ID
50090-1452_bada53f5-21c3-4893-9939-5efba8d0b0b2
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
1983-07-07
Marketing end
0000-00-00
Substance
STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 2 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 3 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; 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 19F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 19A 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 33F CAPSULAR POLYSACCHARIDE ANTIGEN
Active strength
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
Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococc...
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1452-02023-01-30C16284748780-1f386c64a-1ad4-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PNEUMOVAX 23 safely and effectively. See full prescribing information for PNEUMOVAX 23. PNEUMOVAX® 23 (pneumococcal vaccine polyvalent) Sterile, Liquid Vaccine for Intramuscular or Subcutaneous Injection Initial U.S. Approval: 1983

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1452-0PNEUMOVAX 2310 in 1 CARTONINJECTION, SOLUTION1011
50090-1452-9PNEUMOVAX 23.5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION.511

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1452-0ML - Milliliter50090-1452befb5409-3a63-4b60-98d8-94d02fe9a54f12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1452PNEUMOVAX 23 (PNEUMOCOCCAL VACCINE POLYVALENT) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]11Legacy NDC, 2 package rows20200122_4c6db457-2514-48b9-b48a-fa6258aba116.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1658470pneumococcal 23-valent polysaccharide vaccine (PPSV23) 0.5 ML InjectionPSN4c6db457-2514-48b9-b48a-fa6258aba11611
1658472PNEUMOVAX 23 0.5 ML InjectionPSN4c6db457-2514-48b9-b48a-fa6258aba11611
16584720.5 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 antigeSBD4c6db457-2514-48b9-b48a-fa6258aba11611
16584700.5 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 antigeSCD4c6db457-2514-48b9-b48a-fa6258aba11611
1658470pneumococcal capsular polysaccharides (23) 0.5 ML InjectionSY4c6db457-2514-48b9-b48a-fa6258aba11611
1658472Pneumovax 23 (Pneumococcal vaccine polyvalent) 0.5 ML InjectionSY4c6db457-2514-48b9-b48a-fa6258aba11611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-1452-05009014520010 VIAL, SINGLE-DOSE in 1 CARTON (50090-1452-0) > .5 mL in 1 VIAL, SINGLE-DOSE (50090-1452-9) 1983-07-070000-00-00NoNoCurrent
50090-1452-950090145209.5 mL in 1 VIAL, SINGLE-DOSEHistorical