FDA.reportPublic FDA data

VAXNEUVANCE

Product NDC
0006-4329
11-digit product format
000064329
Labeler code
0006
Product ID
0006-4329_1458b014-c05f-484e-b8b4-7bce0927fa22
Type
VACCINE
Nonproprietary name
Pneumococcal 15-valent Conjugate Vaccine CRM197 Protein adsorbed
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Labeler
Merck Sharp & Dohme LLC
Application
BLA125741
Marketing category
BLA
Marketing start
2021-07-16
Substance
CORYNEBACTERIUM DIPHTHERIAE CRM197 PROTEIN; STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 14 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 9V CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN
Active strength
30; 2; 2; 2; 2; 2; 2; 2; 2; 2; 2; 2; 2; 4; 2; 2 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], 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 flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
VAXNEUVANCE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CORYNEBACTERIUM DIPHTHERIAE CRM197 PROTEIN30 ug/.5mL
STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN2 ug/.5mL
STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN2 ug/.5mL
STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN2 ug/.5mL
STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN2 ug/.5mL
STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN2 ug/.5mL
STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN2 ug/.5mL
STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN2 ug/.5mL
STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN2 ug/.5mL
STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN2 ug/.5mL
STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN2 ug/.5mL
STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN2 ug/.5mL
STREPTOCOCCUS PNEUMONIAE TYPE 6A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN2 ug/.5mL
STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN4 ug/.5mL
STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN2 ug/.5mL
STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN2 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
0006-4329-01VAXNEUVANCE0.5 mL in 1 SYRINGE, GLASSINJECTION, SUSPENSION0.514
0006-4329-02VAXNEUVANCE1 in 1 CARTONINJECTION, SUSPENSION114
0006-4329-03VAXNEUVANCE10 in 1 CARTONINJECTION, SUSPENSION1014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-4329-01ML - Milliliter0006-43295fbdebec-8cd9-48ef-8911-4838bf72768f12021-11-09
0006-4329-02ML - Milliliter0006-4329e8bc128c-b0a7-4a0b-9ae4-35f1f76f1f1312021-09-07
0006-4329-03ML - Milliliter0006-43294d7abc00-847b-4073-86b3-eaed9b72695112021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-4329VAXNEUVANCE (PNEUMOCOCCAL 15-VALENT CONJUGATE VACCINE CRM197 PROTEIN ADSORBED) INJECTION, SUSPENSION [MERCK SHARP & DOHME LLC]12Current NDC, Legacy NDC, 3 package rows20240517_1158fa93-ef41-4a29-8252-9251f94c53c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2566416pneumococcal 15-valent conjugate vaccine 0.5 ML Prefilled SyringePSN1158fa93-ef41-4a29-8252-9251f94c53c814
2566422VAXNEUVANCE 0.5 ML Prefilled SyringePSN1158fa93-ef41-4a29-8252-9251f94c53c814
25664220.5 ML Streptococcus pneumoniae serotype 1 capsular antigen diphtheria CRM197 protein conjugate vaccine 0.004 MG/ML / Streptococcus pneumoniae serotype 14 capsular antigen diphtheria CRM197 protein conjugate vaccine 0.004 MG/ML / Streptococcus pneumoniae serotype 18C capsular antigen diphtheria CRM197 protein conjugate vaccine 0.004 MG/ML / Streptococcus pneumoniae serotype 19A capsular antigen diphtheria CRM197 protein conjugate vaccine 0.004 MG/ML / Streptococcus pneumoniae serotype 19F capsular antigen diphtheria CRM197 protein conjugate vaccine 0.004 MG/ML / Streptococcus pneumoniae serotype 22F capsular antigen diphtheria CRM197 protein conjugate vaccine 0.004 MG/ML / Streptococcus pneuSBD1158fa93-ef41-4a29-8252-9251f94c53c814
25664160.5 ML Streptococcus pneumoniae serotype 1 capsular antigen diphtheria CRM197 protein conjugate vaccine 0.004 MG/ML / Streptococcus pneumoniae serotype 14 capsular antigen diphtheria CRM197 protein conjugate vaccine 0.004 MG/ML / Streptococcus pneumoniae serotype 18C capsular antigen diphtheria CRM197 protein conjugate vaccine 0.004 MG/ML / Streptococcus pneumoniae serotype 19A capsular antigen diphtheria CRM197 protein conjugate vaccine 0.004 MG/ML / Streptococcus pneumoniae serotype 19F capsular antigen diphtheria CRM197 protein conjugate vaccine 0.004 MG/ML / Streptococcus pneumoniae serotype 22F capsular antigen diphtheria CRM197 protein conjugate vaccine 0.004 MG/ML / Streptococcus pneuSCD1158fa93-ef41-4a29-8252-9251f94c53c814
2566416pneumococcal 15-valent conjugate vaccine 0.5 ML Prefilled SyringeSY1158fa93-ef41-4a29-8252-9251f94c53c814
2566422Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) 0.5 ML Prefilled SyringeSY1158fa93-ef41-4a29-8252-9251f94c53c814

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0006-4329-01000064329010.5 mL in 1 SYRINGE, GLASS0.5 mlHistorical
0006-4329-02000064329021 SYRINGE, GLASS in 1 CARTON (0006-4329-02) / .5 mL in 1 SYRINGE, GLASS (0006-4329-01) 2021-07-160000-00-00NoNoCurrent
0006-4329-030000643290310 SYRINGE, GLASS in 1 CARTON (0006-4329-03) / .5 mL in 1 SYRINGE, GLASS (0006-4329-01) 2021-07-160000-00-00NoNoCurrent