FDA.reportPublic FDA data

CAPVAXIVE

Product NDC
0006-4347
11-digit product format
000064347
Labeler code
0006
Product ID
0006-4347_4a6738aa-74d3-45d6-b03c-e106f4d62cf3
Type
VACCINE
Nonproprietary name
Pneumococcal 21-valent Conjugate Vaccine
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Merck Sharp & Dohme LLC
Application
BLA125814
Marketing category
BLA
Marketing start
2024-06-17
Substance
CORYNEBACTERIUM DIPHTHERIAE CRM197 PROTEIN; 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 15A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 16F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 17F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 20A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 23A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 23B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 24F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 31 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 35B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 6A 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 9N CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE DEOAC15B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN
Active strength
65; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4 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], 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], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CAPVAXIVE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CORYNEBACTERIUM DIPHTHERIAE CRM197 PROTEIN65 ug/.5mL
STREPTOCOCCUS PNEUMONIAE TYPE 10A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN4 ug/.5mL
STREPTOCOCCUS PNEUMONIAE TYPE 11A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN4 ug/.5mL
STREPTOCOCCUS PNEUMONIAE TYPE 12F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN4 ug/.5mL
STREPTOCOCCUS PNEUMONIAE TYPE 15A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN4 ug/.5mL
STREPTOCOCCUS PNEUMONIAE TYPE 16F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN4 ug/.5mL
STREPTOCOCCUS PNEUMONIAE TYPE 17F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN4 ug/.5mL
STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN4 ug/.5mL
STREPTOCOCCUS PNEUMONIAE TYPE 20A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN4 ug/.5mL
STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN4 ug/.5mL
STREPTOCOCCUS PNEUMONIAE TYPE 23A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN4 ug/.5mL
STREPTOCOCCUS PNEUMONIAE TYPE 23B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN4 ug/.5mL
STREPTOCOCCUS PNEUMONIAE TYPE 24F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN4 ug/.5mL
STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN4 ug/.5mL
STREPTOCOCCUS PNEUMONIAE TYPE 31 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN4 ug/.5mL
STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN4 ug/.5mL
STREPTOCOCCUS PNEUMONIAE TYPE 35B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN4 ug/.5mL
STREPTOCOCCUS PNEUMONIAE TYPE 6A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN4 ug/.5mL
STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN4 ug/.5mL
STREPTOCOCCUS PNEUMONIAE TYPE 8 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN4 ug/.5mL
STREPTOCOCCUS PNEUMONIAE TYPE 9N CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN4 ug/.5mL
STREPTOCOCCUS PNEUMONIAE TYPE DEOAC15B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN4 ug/.5mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0006-4347-01CAPVAXIVE1 in 1 CARTONINJECTION, SOLUTION14
0006-4347-02CAPVAXIVE10 in 1 CARTONINJECTION, SOLUTION104
0006-4347-99CAPVAXIVE0.5 mL in 1 SYRINGEINJECTION, SOLUTION0.54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-4347-01ML - Milliliter0006-4347e470da37-10e3-4bc8-939e-a459f25f6fa912024-12-10
0006-4347-02ML - Milliliter0006-434754ac8ff2-61f5-42fa-a26a-66ef8725509e12024-07-12
0006-4347-99ML - Milliliter0006-4347561b5893-cc27-472e-98f1-fc30daa1177412024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-4347CAPVAXIVE (PNEUMOCOCCAL 21-VALENT CONJUGATE VACCINE) INJECTION, SOLUTION [MERCK SHARP & DOHME LLC]2Current NDC, 3 package rows20240704_1a264c2f-d2f8-4ab5-bc5e-fbed0001ede6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2686978CAPVAXIVE vaccine 0.5 ML Prefilled SyringePSN1a264c2f-d2f8-4ab5-bc5e-fbed0001ede64
2686972pneumococcal 21-valent conjugate vaccine (PCV21) 0.5 ML Prefilled SyringePSN1a264c2f-d2f8-4ab5-bc5e-fbed0001ede64
26869780.5 ML Streptococcus pneumoniae serotype 10A capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 11A capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 12F capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 15A capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 16F capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 17F capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pSBD1a264c2f-d2f8-4ab5-bc5e-fbed0001ede64
26869720.5 ML Streptococcus pneumoniae serotype 10A capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 11A capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 12F capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 15A capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 16F capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 17F capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pSCD1a264c2f-d2f8-4ab5-bc5e-fbed0001ede64
2686978Capvaxive (Pneumococcal 21-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) 0.5 ML Prefilled SyringeSY1a264c2f-d2f8-4ab5-bc5e-fbed0001ede64
2686972pneumococcal 21-valent conjugate vaccine (diphtheria CRM197 Protein) 0.5 ML Prefilled SyringeSY1a264c2f-d2f8-4ab5-bc5e-fbed0001ede64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0006-4347-01000064347011 SYRINGE in 1 CARTON (0006-4347-01) / .5 mL in 1 SYRINGE (0006-4347-99) 1 syringe2024-06-17NoNoCurrent
0006-4347-020000643470210 SYRINGE in 1 CARTON (0006-4347-02) / .5 mL in 1 SYRINGE (0006-4347-99) 10 syringe2024-06-17NoNoCurrent
0006-4347-99000064347990.5 mL in 1 SYRINGE0.5 mlHistorical