PedvaxHIB

Product NDC
0006-4897
11-digit product format
000064897
Labeler code
0006
Product ID
0006-4897_19d4c656-416f-4499-857b-dcc7bed8ccb6
Type
VACCINE
Nonproprietary name
Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Labeler
Merck Sharp & Dohme LLC
Application
BLA103237
Marketing category
BLA
Marketing start
1989-12-20
Substance
HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN
Active strength
7.5 ug/.5mL
Pharmacologic classes
Actively Acquired Immunity [PE], Haemophilus Vaccines [CS], Inactivated Haemophilus Influenzae B Vaccine [EPC], 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
PedvaxHIB
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN7.5 ug/.5mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0006-4897-00PedvaxHIB10 in 1 CARTONINJECTION, SUSPENSION1019
0006-4897-01PedvaxHIB0.5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION0.519

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-4897-00ML - Milliliter0006-4897e652adf2-2d2c-4b7c-990d-526a5d5e448912013-02-13
0006-4897-01ML - Milliliter0006-4897f1b1ee3b-4918-4535-9839-9b96fd320b6112014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGENACTIVE INGREDIENTLUY6P8763WPEDVAXHIB (HAEMOPHILUS B CONJUGATE VACCINE (MENINGOCOCCAL PROTEIN CONJUGATE)) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]8
HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGENACTIVE MOIETYLUY6P8763WPEDVAXHIB (HAEMOPHILUS B CONJUGATE VACCINE (MENINGOCOCCAL PROTEIN CONJUGATE)) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]8
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XPEDVAXHIB (HAEMOPHILUS B CONJUGATE VACCINE (MENINGOCOCCAL PROTEIN CONJUGATE)) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-4897PEDVAXHIB (HAEMOPHILUS B CONJUGATE VACCINE (MENINGOCOCCAL PROTEIN CONJUGATE)) INJECTION, SUSPENSION [MERCK SHARP & DOHME LLC]18Current NDC, Legacy NDC, 2 package rows20241031_9dff46c6-4b15-4d10-aca6-d5ef3735a530.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
798447Haemophilus b (meningococcal protein conjugate) (Hib) 0.5 mL InjectionPSN9dff46c6-4b15-4d10-aca6-d5ef3735a53019
798451PedvaxHIB vaccine 0.5 ML InjectionPSN9dff46c6-4b15-4d10-aca6-d5ef3735a53019
7984510.5 ML Haemophilus influenzae b (Ross strain) capsular polysaccharide meningococcal protein conjugate vaccine 0.265 MG/ML Injection [PedvaxHIB]SBD9dff46c6-4b15-4d10-aca6-d5ef3735a53019
7984470.5 ML Haemophilus influenzae b (Ross strain) capsular polysaccharide meningococcal protein conjugate vaccine 0.265 MG/ML InjectionSCD9dff46c6-4b15-4d10-aca6-d5ef3735a53019
7984510.5 ML PedvaxHIB 0.265 MG/ML InjectionSY9dff46c6-4b15-4d10-aca6-d5ef3735a53019
798447Haemophilus b conjugate vaccine (meningococcal protein conjugate) 0.5 ML InjectionSY9dff46c6-4b15-4d10-aca6-d5ef3735a53019
798451PedvaxHIB, Haemophilus b conjugate vaccine (Meningococcal protein conjugate) 0.5 ML InjectionSY9dff46c6-4b15-4d10-aca6-d5ef3735a53019

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0006-4897-000000648970010 VIAL, SINGLE-DOSE in 1 CARTON (0006-4897-00) / .5 mL in 1 VIAL, SINGLE-DOSE (0006-4897-01) 1989-12-200000-00-00NoNoCurrent
0006-4897-01000064897010.5 mL in 1 VIAL, SINGLE-DOSE0.5 mlHistorical