NDC 43528-003

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 ID43528-003_b9f87a1a-cf96-4ae4-8dde-7d6841123888
NDC43528-003
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 Through2022-12-31

Packaging

NDC 43528-003-05

5 SYRINGE in 1 CARTON (43528-003-05) > .5 mL in 1 SYRINGE (43528-003-01)
Marketing Start Date2018-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43528-003-01 [43528000301]

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

NDC 43528-003-05 [43528000305]

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

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