NDC 68258-8912

HAVRIX

Hepatitis A Vaccine

HAVRIX is a Intramuscular Injection, Suspension in the Vaccine category. It is labeled and distributed by Dispensing Solutions, Inc.. The primary component is Hepatitis A Virus Strain Hm175 Antigen (formaldehyde Inactivated).

Product ID68258-8912_c319ee15-43a9-4864-a4c1-40ffb50d9e5a
NDC68258-8912
Product TypeVaccine
Proprietary NameHAVRIX
Generic NameHepatitis A Vaccine
Dosage FormInjection, Suspension
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2007-04-13
Marketing CategoryBLA / BLA
Application NumberBLA103475
Labeler NameDispensing Solutions, Inc.
Substance NameHEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED)
Active Ingredient Strength1440 [iU]/mL
Pharm ClassesInactivated Hepatitis A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis A Vaccines [CS],Vaccines, Inactivated [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 68258-8912-9

1 mL in 1 VIAL (68258-8912-9)
Marketing Start Date2007-04-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68258-8912-9 [68258891209]

HAVRIX INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA103475
Product TypeVACCINE
Marketing Start Date2007-04-13
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED)1440 [iU]/mL

Pharmacological Class

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

NDC Crossover Matching brand name "HAVRIX" or generic name "Hepatitis A Vaccine"

NDCBrand NameGeneric Name
50090-1502HAVRIXHepatitis A Vaccine
55045-3841HAVRIXHepatitis A Vaccine
58160-825HAVRIXHepatitis A Vaccine
58160-826HAVRIXHepatitis A Vaccine
68258-8912HAVRIXHepatitis A Vaccine

Trademark Results [HAVRIX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HAVRIX
HAVRIX
74042847 1701341 Live/Registered
SmithKline Biologicals, S.A.
1990-03-26

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