Hepatitis B Surface Antigen Vaccine Injection

Brand(s)
Engerix-B, Recombivax
Category(s)
other, prescription
SPL Type(s)
Human Prescription, Vaccine
Master SPL
Merck Sharp & Dohme Corp. (2014-11-05)
Oldest Current Product
1986-07-23
License(s)
BLA
RxNORM
INJECTION\HEPATITIS B SURFACE ANTIGEN VACCINE
SPL Active
INTRAMUSCULAR\INJECTION, SUSPENSION\HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN
INTRAMUSCULAR\INJECTION, SUSPENSION\HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN
SPL Moiety
INTRAMUSCULAR\INJECTION, SUSPENSION\HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN
INTRAMUSCULAR\INJECTION, SUSPENSION\HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN

product(s) by strength(s)

1 ml hepatitis b surface antigen vaccine 0.01 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000064995RecombivaxBLAMerck Sharp & Dohme Corp.1986-07-23HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGENINTRAMUSCULARINJECTION, SUSPENSION101066b5bd99e4-569d-48d5-ba75-16e69f8c409a

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1521250837RecombivaxBLARemedyrepack Inc.2014-02-20HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGENINTRAMUSCULARINJECTION, SUSPENSION00006499510106612ead270-acf4-45fb-bb9c-d6f726f68712

0.5 ml hepatitis b surface antigen vaccine 0.01 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000064981RecombivaxBLAMerck Sharp & Dohme Corp.1986-07-23HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGENINTRAMUSCULARINJECTION, SUSPENSION101066b5bd99e4-569d-48d5-ba75-16e69f8c409a

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1682583042Engerix-BBLADispensing Solutions, Inc.2009-05-28HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGENINTRAMUSCULARINJECTION, SUSPENSION581600821111032394d930f24-4ddb-488d-9e79-3f495972733b

1 ml hepatitis b surface antigen vaccine 0.04 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000064992RecombivaxBLAMerck Sharp & Dohme Corp.1986-07-23HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGENINTRAMUSCULARINJECTION, SUSPENSION101066b5bd99e4-569d-48d5-ba75-16e69f8c409a

application(s)

#idtitleapprovedtradenamesfda division
1101066Hepatitis B Vaccine (Recombinant) Application1986-07-23Recombivax, Recombivax HBCBER
2103239Hepatitis B Vaccine (Recombinant) Application1989-08-28Engerix-BCBER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
112ead270-acf4-45fb-bb9c-d6f726f68712 (view SPL)RECOMBIVAXHBHEPATITISB VACCINE (RECOMBINANT)otherVaccineRemedyrepack Inc.2014-02-202521250837
24d930f24-4ddb-488d-9e79-3f495972733b (view SPL)ENGERIX-B Hepatitis B Vaccine (Recombinant)prescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2010-03-021682583042
3b5bd99e4-569d-48d5-ba75-16e69f8c409a (view SPL)These highlights do not include all the information needed to use RECOMBIVAX HB safely and effectively. See full prescribing information for RECOMBIVAX HB. RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) Suspension for intramuscular injection Initial U.S. Approval: 1983otherVaccineMerck Sharp & Dohme Corp.API MANUFACTURE, MANUFACTURE, PACK2014-11-0519000064981, 000064992, 000064995, 000064093, 000064094Hepatitis B Surface Antigen Vaccine Prefilled Syringe

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII