0006-4897 NDC - PEDVAXHIB (HAEMOPHILUS B CONJUGATE VACCINE (MENINGOCOCCAL PROTEIN CONJUGATE))

Drug Information

Product NDC: 0006-4897

Proprietary Name: PedvaxHIB

Non Proprietary Name: Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)

Active Ingredient(s):
  • 7.5 ug/.5mL HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN


Administration Route(s): INTRAMUSCULAR

Dosage Form(s): INJECTION, SUSPENSION

Pharmacy Class(es):
  • Actively Acquired Immunity [PE];
  • Haemophilus Vaccines [CS];
  • Inactivated Haemophilus Influenzae B Vaccine [EPC];
  • Vaccines;
  • Inactivated [CS]

Labeler Information

Labeler Name: Merck Sharp & Dohme Corp.
Product Type: VACCINE
FDA Application Number: BLA103237
Marketing Category: BLA
Start Marketing Date:12/20/1989

Package Information

No. Package Code Package Description Billing Unit
10006-4897-0010 VIAL, SINGLE-DOSE in 1 CARTON (0006-4897-00) > .5 mL in 1 VIAL, SINGLE-DOSE (0006-4897-01)ML

NDC Record

Field Name Field Value Definition
PRODUCT NDC0006-4897The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEVACCINEIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEPedvaxHIBThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEHaemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEINJECTION, SUSPENSIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEINTRAMUSCULARThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE12/20/1989This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEBLAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERBLA103237This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEMerck Sharp & Dohme Corp.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEHAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGENThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH7.5 
ACTIVE INGRED UNITug/.5mL 
PHARM CLASSESActively Acquired Immunity [PE],Haemophilus Vaccines [CS],Inactivated Haemophilus Influenzae B Vaccine [EPC],Vaccines, Inactivated [CS] 

Download Record

Download this NDC record in Text format: Export

Download this NDC record in Excel (CSV) format: Export

Download this NDC record in XML format: Export

This page was last updated on: 1/24/2020