NDC 43528-002

HEPLISAV-B

Hepatitis B Vaccine (recombinant) Adjuvanted

HEPLISAV-B is a Intramuscular Injection, Solution in the Vaccine category. It is labeled and distributed by Dynavax Technologies Corporation. The primary component is Hepatitis B Virus Subtype Adw Hbsag Surface Protein Antigen.

Product ID43528-002_cf21c709-2864-4ded-9b5f-b41f1f0f8f0b
NDC43528-002
Product TypeVaccine
Proprietary NameHEPLISAV-B
Generic NameHepatitis B Vaccine (recombinant) Adjuvanted
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2018-01-01
Marketing CategoryBLA / BLA
Application NumberBLA125428
Labeler NameDynavax Technologies Corporation
Substance NameHEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN
Active Ingredient Strength20 ug/.5mL
Pharm ClassesInactivated Hepatitis B Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis B Vaccines [CS],Vaccines, Inactivated [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 43528-002-05

5 VIAL in 1 CARTON (43528-002-05) > .5 mL in 1 VIAL (43528-002-01)
Marketing Start Date2018-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43528-002-01 [43528000201]

HEPLISAV-B INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA125428
Product TypeVACCINE
Billing UnitML
Marketing Start Date2018-01-01
Marketing End Date2019-10-17

NDC 43528-002-05 [43528000205]

HEPLISAV-B INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA125428
Product TypeVACCINE
Billing UnitML
Marketing Start Date2018-01-01
Marketing End Date2019-10-17

Drug Details

Active Ingredients

IngredientStrength
HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN20 ug/.5mL

Pharmacological Class

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

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

NDCBrand NameGeneric Name
43528-002HEPLISAV-BHepatitis B Vaccine (Recombinant) Adjuvanted
43528-003HEPLISAV-BHepatitis B Vaccine (Recombinant) Adjuvanted
50090-3469HEPLISAV-BHepatitis B Vaccine (Recombinant) Adjuvanted

Trademark Results [HEPLISAV-B]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HEPLISAV-B
HEPLISAV-B
98014169 not registered Live/Pending
Dynavax Technologies Corporation
2023-05-25
HEPLISAV-B
HEPLISAV-B
98014166 not registered Live/Pending
Dynavax Technologies Corporation
2023-05-25
HEPLISAV-B
HEPLISAV-B
98014161 not registered Live/Pending
Dynavax Technologies Corporation
2023-05-25
HEPLISAV-B
HEPLISAV-B
87145972 5419134 Live/Registered
Dynavax Technologies Corporation
2016-08-22
HEPLISAV-B
HEPLISAV-B
85840674 not registered Dead/Abandoned
Dynavax Technologies Corporation
2013-02-05
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