NDC 58160-821

ENGERIX-B

Hepatitis B Vaccine (recombinant)

ENGERIX-B is a Intramuscular Injection, Suspension in the Vaccine category. It is labeled and distributed by Glaxosmithkline Biologicals Sa. The primary component is Hepatitis B Virus Subtype Adw2 Hbsag Surface Protein Antigen.

Product ID58160-821_15267df3-c997-4e6a-95bd-049846838c23
NDC58160-821
Product TypeVaccine
Proprietary NameENGERIX-B
Generic NameHepatitis B Vaccine (recombinant)
Dosage FormInjection, Suspension
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2007-03-28
Marketing CategoryBLA / BLA
Application NumberBLA103239
Labeler NameGlaxoSmithKline Biologicals SA
Substance NameHEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN
Active Ingredient Strength20 ug/mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 58160-821-11

10 VIAL in 1 CARTON (58160-821-11) > 1 mL in 1 VIAL (58160-821-01)
Marketing Start Date2007-03-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58160-821-32 [58160082132]

ENGERIX-B INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA103239
Product TypeVACCINE
Billing UnitML
Marketing Start Date2009-11-16
Marketing End Date2013-07-31

NDC 58160-821-34 [58160082134]

ENGERIX-B INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA103239
Product TypeVACCINE
Billing UnitML
Marketing Start Date2012-03-09

NDC 58160-821-48 [58160082148]

ENGERIX-B INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA103239
Product TypeVACCINE
Marketing Start Date2010-08-03
Marketing End Date2013-07-31

NDC 58160-821-11 [58160082111]

ENGERIX-B INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA103239
Product TypeVACCINE
Billing UnitML
Marketing Start Date2007-03-28

NDC 58160-821-43 [58160082143]

ENGERIX-B INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA103239
Product TypeVACCINE
Billing UnitML
Marketing Start Date2010-08-03

NDC 58160-821-52 [58160082152]

ENGERIX-B INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA103239
Product TypeVACCINE
Billing UnitML
Marketing Start Date2011-01-06

NDC 58160-821-31 [58160082131]

ENGERIX-B INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA103239
Product TypeVACCINE
Marketing Start Date2007-03-28
Marketing End Date2013-07-31

NDC 58160-821-46 [58160082146]

ENGERIX-B INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA103239
Product TypeVACCINE
Marketing Start Date2007-03-28
Marketing End Date2013-07-31

NDC 58160-821-05 [58160082105]

ENGERIX-B INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA103239
Product TypeVACCINE
Marketing Start Date2012-03-09

NDC 58160-821-01 [58160082101]

ENGERIX-B INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA103239
Product TypeVACCINE
Billing UnitML
Marketing Start Date2007-03-28

Drug Details

Active Ingredients

IngredientStrength
HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN20 ug/mL

NDC Crossover Matching brand name "ENGERIX-B" or generic name "Hepatitis B Vaccine (recombinant)"

NDCBrand NameGeneric Name
50090-1223ENGERIX-BHepatitis B Vaccine (Recombinant)
50090-1706ENGERIX-BHepatitis B Vaccine (Recombinant)
58160-820ENGERIX-BHepatitis B Vaccine (Recombinant)
58160-821ENGERIX-BHepatitis B Vaccine (Recombinant)
68258-3042ENGERIX-BENGERIX-B
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)

Trademark Results [ENGERIX-B]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ENGERIX-B
ENGERIX-B
76050783 2832321 Live/Registered
GLAXOSMITHKLINE BIOLOGICALS S.A.
2000-05-17
ENGERIX-B
ENGERIX-B
76050489 2451009 Live/Registered
GLAXOSMITHKLINE BIOLOGICALS S.A.
2000-05-17
ENGERIX-B
ENGERIX-B
75022211 2019144 Live/Registered
GLAXOSMITHKLINE BIOLOGICALS S.A
1995-11-16

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