FDA.reportPublic FDA data

RECOMBIVAX HB

Product NDC
0006-4992
11-digit product format
000064992
Labeler code
0006
Product ID
0006-4992_32dbed7b-c62b-4294-8476-d134c8c1a6f4
Type
VACCINE
Nonproprietary name
Hepatitis B Vaccine (Recombinant)
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR; SUBCUTANEOUS
Labeler
Merck Sharp & Dohme LLC
Application
BLA101066
Marketing category
BLA
Marketing start
1986-07-23
Substance
HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN
Active strength
40 ug/mL
Pharmacologic classes
Actively Acquired Immunity [PE], Hepatitis B Vaccines [CS], Inactivated Hepatitis B Virus 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
RECOMBIVAX HB
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN40 ug/mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0006-4992-00RECOMBIVAX HB1 in 1 CARTONINJECTION, SUSPENSION132
0006-4992-01RECOMBIVAX HB1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION132

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-4992-00ML - Milliliter0006-4992a043c00d-f006-4fe0-a56d-f1ea70ddd63212013-02-13
0006-4992-01ML - Milliliter0006-4992f5440908-79fd-4bf8-b709-4d65eb09865c12017-12-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGENACTIVE INGREDIENTXL4HLC6JH6RECOMBIVAX HB (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]19
HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGENACTIVE MOIETYXL4HLC6JH6RECOMBIVAX HB (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-4992RECOMBIVAX HB (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [MERCK SHARP & DOHME LLC]31Current NDC, Legacy NDC, 2 package rows20241109_b5bd99e4-569d-48d5-ba75-16e69f8c409a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1658149hepatitis B vaccine (recombinant) adult (HepB) 10 MCG in 1 ML InjectionPSNb5bd99e4-569d-48d5-ba75-16e69f8c409a32
830243hepatitis B vaccine (recombinant) adult (HepB) 10 MCG in 1 ML Prefilled SyringePSNb5bd99e4-569d-48d5-ba75-16e69f8c409a32
830261hepatitis B vaccine (recombinant) dialysis formulation (HepB) 40 MCG in 1 ML InjectionPSNb5bd99e4-569d-48d5-ba75-16e69f8c409a32
1658154hepatitis B vaccine (recombinant) pediatric/adolescent (HepB) 5 MCG/0.5 ML InjectionPSNb5bd99e4-569d-48d5-ba75-16e69f8c409a32
830252hepatitis B vaccine (recombinant) pediatric/adolescent (HepB) 5 MCG/0.5 ML Prefilled SyringePSNb5bd99e4-569d-48d5-ba75-16e69f8c409a32
1658150RECOMBIVAX HB adult vaccine 1 ML InjectionPSNb5bd99e4-569d-48d5-ba75-16e69f8c409a32
830245RECOMBIVAX HB adult vaccine 1 ML Prefilled SyringePSNb5bd99e4-569d-48d5-ba75-16e69f8c409a32
830263RECOMBIVAX HB dialysis formulation vaccine 1 ML InjectionPSNb5bd99e4-569d-48d5-ba75-16e69f8c409a32
1658155RECOMBIVAX HB pediatric/adolescent vaccine 0.5 ML InjectionPSNb5bd99e4-569d-48d5-ba75-16e69f8c409a32
830253RECOMBIVAX HB pediatric/adolescent vaccine 0.5 ML Prefilled SyringePSNb5bd99e4-569d-48d5-ba75-16e69f8c409a32
16581550.5 ML hepatitis B surface antigen vaccine 0.01 MG/ML Injection [Recombivax]SBDb5bd99e4-569d-48d5-ba75-16e69f8c409a32
8302530.5 ML hepatitis B surface antigen vaccine 0.01 MG/ML Prefilled Syringe [Recombivax]SBDb5bd99e4-569d-48d5-ba75-16e69f8c409a32
16581501 ML hepatitis B surface antigen vaccine 0.01 MG/ML Injection [Recombivax]SBDb5bd99e4-569d-48d5-ba75-16e69f8c409a32
8302451 ML hepatitis B surface antigen vaccine 0.01 MG/ML Prefilled Syringe [Recombivax]SBDb5bd99e4-569d-48d5-ba75-16e69f8c409a32
8302631 ML hepatitis B surface antigen vaccine 0.04 MG/ML Injection [Recombivax]SBDb5bd99e4-569d-48d5-ba75-16e69f8c409a32
16581540.5 ML hepatitis B surface antigen vaccine 0.01 MG/ML InjectionSCDb5bd99e4-569d-48d5-ba75-16e69f8c409a32
8302520.5 ML hepatitis B surface antigen vaccine 0.01 MG/ML Prefilled SyringeSCDb5bd99e4-569d-48d5-ba75-16e69f8c409a32
16581491 ML hepatitis B surface antigen vaccine 0.01 MG/ML InjectionSCDb5bd99e4-569d-48d5-ba75-16e69f8c409a32
8302431 ML hepatitis B surface antigen vaccine 0.01 MG/ML Prefilled SyringeSCDb5bd99e4-569d-48d5-ba75-16e69f8c409a32
8302611 ML hepatitis B surface antigen vaccine 0.04 MG/ML InjectionSCDb5bd99e4-569d-48d5-ba75-16e69f8c409a32
16581550.5 ML Recombivax 0.01 MG/ML InjectionSYb5bd99e4-569d-48d5-ba75-16e69f8c409a32
8302530.5 ML Recombivax HB Pediatric/Adolescent 10 MCG/ML Prefilled SyringeSYb5bd99e4-569d-48d5-ba75-16e69f8c409a32
8302530.5 ML Recombivax HB, hepatitis B vaccine (recombinant) Prefilled SyringeSYb5bd99e4-569d-48d5-ba75-16e69f8c409a32
16581501 ML Recombivax 0.01 MG/ML InjectionSYb5bd99e4-569d-48d5-ba75-16e69f8c409a32
8302631 ML Recombivax 0.04 MG/ML InjectionSYb5bd99e4-569d-48d5-ba75-16e69f8c409a32
8302451 ML Recombivax HB, Hepatitis B vaccine (recombinant) adult formulation Prefilled SyringeSYb5bd99e4-569d-48d5-ba75-16e69f8c409a32
830252hepatitis B surface antigen vaccine 0.005 MG per 0.5 ML Prefilled SyringeSYb5bd99e4-569d-48d5-ba75-16e69f8c409a32
830243hepatitis B surface antigen vaccine 0.01 MG per 1 ML Prefilled SyringeSYb5bd99e4-569d-48d5-ba75-16e69f8c409a32
1658149hepatitis B surface antigen vaccine 10 MCG per 1 ML InjectionSYb5bd99e4-569d-48d5-ba75-16e69f8c409a32
830243hepatitis B surface antigen vaccine 10 MCG per 1 ML Prefilled SyringeSYb5bd99e4-569d-48d5-ba75-16e69f8c409a32
830261hepatitis B surface antigen vaccine 40 MCG in 1 ML InjectionSYb5bd99e4-569d-48d5-ba75-16e69f8c409a32
1658154hepatitis B surface antigen vaccine 5 MCG per 0.5 ML InjectionSYb5bd99e4-569d-48d5-ba75-16e69f8c409a32
830252hepatitis B surface antigen vaccine 5 MCG per 0.5 ML Prefilled SyringeSYb5bd99e4-569d-48d5-ba75-16e69f8c409a32
1658150Recombivax HB 10 MCG per 1 ML InjectionSYb5bd99e4-569d-48d5-ba75-16e69f8c409a32
830263Recombivax HB 40 MCG per 1 ML InjectionSYb5bd99e4-569d-48d5-ba75-16e69f8c409a32
1658155Recombivax HB 5 MCG per 0.5 ML InjectionSYb5bd99e4-569d-48d5-ba75-16e69f8c409a32
830253Recombivax HB 5 MCG per 0.5 ML Prefilled SyringeSYb5bd99e4-569d-48d5-ba75-16e69f8c409a32
830245Recombivax HB, Hepatitis B vaccine (recombinant) adult formulation 10 MCG per 1 ML Prefilled SyringeSYb5bd99e4-569d-48d5-ba75-16e69f8c409a32
830263Recombivax HB, Hepatitis B vaccine (recombinant) Dialysis Formulation 40 MCG per 1 ML InjectionSYb5bd99e4-569d-48d5-ba75-16e69f8c409a32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0006-4992-00000064992001 VIAL, SINGLE-DOSE in 1 CARTON (0006-4992-00) / 1 mL in 1 VIAL, SINGLE-DOSE (0006-4992-01) 1986-07-230000-00-00NoNoCurrent
0006-4992-01000064992011 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical