NDC 0006-4897

PedvaxHIB

Haemophilus B Conjugate Vaccine (meningococcal Protein Conjugate)

PedvaxHIB is a Intramuscular Injection, Suspension in the Vaccine category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Haemophilus Influenzae Type B Capsular Polysaccharide Meningococcal Outer Membrane Protein Conjugate Antigen.

Product ID0006-4897_03e8f60a-7fe8-4dcc-933c-5ad199c03e53
NDC0006-4897
Product TypeVaccine
Proprietary NamePedvaxHIB
Generic NameHaemophilus B Conjugate Vaccine (meningococcal Protein Conjugate)
Dosage FormInjection, Suspension
Route of AdministrationINTRAMUSCULAR
Marketing Start Date1989-12-20
Marketing CategoryBLA / BLA
Application NumberBLA103237
Labeler NameMerck Sharp & Dohme Corp.
Substance NameHAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN
Active Ingredient Strength8 ug/.5mL
Pharm ClassesActively Acquired Immunity [PE],Haemophilus Vaccines [CS],Inactivated Haemophilus Influenzae B Vaccine [EPC],Vaccines, Inactivated [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0006-4897-00

10 VIAL, SINGLE-DOSE in 1 CARTON (0006-4897-00) > .5 mL in 1 VIAL, SINGLE-DOSE (0006-4897-01)
Marketing Start Date1989-12-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0006-4897-01 [00006489701]

PedvaxHIB INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA103237
Product TypeVACCINE
Billing UnitML
Marketing Start Date2013-12-13

NDC 0006-4897-00 [00006489700]

PedvaxHIB INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA103237
Product TypeVACCINE
Billing UnitML
Marketing Start Date1989-12-20

Drug Details

Active Ingredients

IngredientStrength
HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN7.5 ug/.5mL

Pharmacological Class

  • Actively Acquired Immunity [PE]
  • Haemophilus Vaccines [CS]
  • Inactivated Haemophilus Influenzae B Vaccine [EPC]
  • Vaccines
  • Inactivated [CS]

Trademark Results [PedvaxHIB]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PEDVAXHIB
PEDVAXHIB
73796368 1610999 Live/Registered
MERCK & CO., INC.
1989-04-28

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