NDC 50090-1502

HAVRIX

Hepatitis A Vaccine

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

Product ID50090-1502_462d13e5-1b52-4f61-ba69-f714457d51c7
NDC50090-1502
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 NameA-S Medication Solutions
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 FlagN
Listing Certified Through2021-12-31

Packaging

NDC 50090-1502-0

10 SYRINGE in 1 CARTON (50090-1502-0) > 1 mL in 1 SYRINGE (50090-1502-9)
Marketing Start Date2007-04-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50090-1502-9 [50090150209]

HAVRIX INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA103475
Product TypeVACCINE
Marketing Start Date2007-04-13

NDC 50090-1502-0 [50090150200]

HAVRIX INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA103475
Product TypeVACCINE
Billing UnitML
Marketing Start Date2007-04-13

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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