NDC 0006-4094

RECOMBIVAX HB

Hepatitis B Vaccine (recombinant)

RECOMBIVAX HB is a Intramuscular; Subcutaneous Injection, Suspension in the Vaccine category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Hepatitis B Virus Subtype Adw Hbsag Surface Protein Antigen.

Product ID0006-4094_154095f6-aada-4a3f-a0b2-76009c1922e4
NDC0006-4094
Product TypeVaccine
Proprietary NameRECOMBIVAX HB
Generic NameHepatitis B Vaccine (recombinant)
Dosage FormInjection, Suspension
Route of AdministrationINTRAMUSCULAR; SUBCUTANEOUS
Marketing Start Date1986-07-23
Marketing CategoryBLA / BLA
Application NumberBLA101066
Labeler NameMerck Sharp & Dohme Corp.
Substance NameHEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN
Active Ingredient Strength10 ug/mL
Pharm ClassesInactivated Hepatitis B Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis B Vaccines [CS],Vaccines, Inactivated [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0006-4094-02

10 SYRINGE in 1 CARTON (0006-4094-02) > 1 mL in 1 SYRINGE (0006-4094-01)
Marketing Start Date1986-07-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0006-4094-01 [00006409401]

RECOMBIVAX HB INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA101066
Product TypeVACCINE
Billing UnitML
Marketing Start Date1986-07-23

NDC 0006-4094-09 [00006409409]

RECOMBIVAX HB INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA101066
Product TypeVACCINE
Billing UnitML
Marketing Start Date1986-07-23

NDC 0006-4094-02 [00006409402]

RECOMBIVAX HB INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA101066
Product TypeVACCINE
Billing UnitML
Marketing Start Date2014-03-21

Drug Details

Active Ingredients

IngredientStrength
HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN10 ug/mL

Pharmacological Class

  • Inactivated Hepatitis B Virus Vaccine [EPC]
  • Actively Acquired Immunity [PE]
  • Hepatitis B Vaccines [CS]
  • Vaccines
  • Inactivated [CS]

NDC Crossover Matching brand name "RECOMBIVAX HB" or generic name "Hepatitis B Vaccine (recombinant)"

NDCBrand NameGeneric Name
0006-4093RECOMBIVAX HBHepatitis B Vaccine (Recombinant)
0006-4094RECOMBIVAX HBHepatitis B Vaccine (Recombinant)
0006-4981RECOMBIVAX HBHepatitis B Vaccine (Recombinant)
0006-4992RECOMBIVAX HBHepatitis B Vaccine (Recombinant)
0006-4995RECOMBIVAX HBHepatitis B Vaccine (Recombinant)
50090-1716RECOMBIVAX HBHepatitis B Vaccine (Recombinant)
50090-1719RECOMBIVAX HBHepatitis B Vaccine (Recombinant)
50090-1849RECOMBIVAX HBHepatitis B Vaccine (Recombinant)
50090-1223ENGERIX-BHepatitis B Vaccine (Recombinant)
50090-1706ENGERIX-BHepatitis B Vaccine (Recombinant)
58160-820ENGERIX-BHepatitis B Vaccine (Recombinant)
58160-821ENGERIX-BHepatitis B Vaccine (Recombinant)

Trademark Results [RECOMBIVAX HB]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RECOMBIVAX HB
RECOMBIVAX HB
73509689 1338762 Live/Registered
Merck & Co., Inc.
1984-11-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.