NDC 58160-821-52 Engerix-b

Hepatitis B Vaccine (recombinant)

NDC Package Code 58160-821-52

Field Name Field Value
NDC Code 58160-821-52
Package Description 10 SYRINGE in 1 CARTON > 1 mL in 1 SYRINGE (58160-821-43)
Proprietary Name Engerix-b Additional informationCallout TooltipWhat is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Hepatitis B Vaccine (recombinant) Additional informationCallout TooltipWhat is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
11-Digit NDC Billing Format 58160082152 Additional informationCallout TooltipNDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
Billing Unit ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Product Type Vaccine Additional informationCallout TooltipWhat kind of product is this?
Indicates 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.
Labeler Name Glaxosmithkline Biologicals Sa
Dosage Form Injection, Suspension - A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. It can also consist of an oil phase dispersed throughout an aqueous phase, or vice-versa.
Administration Route(s)
  • Intramuscular - Administration within a muscle.
Active Ingredient(s)
  • HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN 20 ug/mL
Marketing Category BLA - A product marketed under an approved Biologic License Application. Additional informationCallout TooltipWhat is the Marketing Category?
Product 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.
FDA Application Number BLA103239 Additional informationCallout TooltipWhat is the FDA Application Number?
This 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.
Start Marketing Date 03-28-2007 Additional informationCallout TooltipWhat is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

The NDC Code 58160-821-52 is assigned to Engerix-b, a vaccine lable labeled by Glaxosmithkline Biologicals Sa. The product's dosage form is injection, suspension and is administered via intramuscular form.


Code Structure
  • 58160 - Glaxosmithkline Biologicals Sa
    • 58160-821 - Engerix-b
      • 58160-821-52 - 10 SYRINGE in 1 CARTON

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

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NDC HCPCS Crosswalk

This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

NDC 58160-821-52 HCPCS crosswalk information with package details and bill units information.

NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
5816008215290740HEPB VACC 3 DOSE IMMUNSUP IM40 MCG1100.55
5816008215290746HEPB VACCINE 3 DOSE ADULT IM1 EACH110110
5816008215290747HEPB VACC 4 DOSE IMMUNSUP IM40 MCG1100.55

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Other Product Packages

The following packages are also available for Engerix-b with product NDC 58160-821.

NDC Package CodePackage Description
58160-821-1110 VIAL in 1 CARTON > 1 mL in 1 VIAL (58160-821-01)
58160-821-341 SYRINGE in 1 CARTON > 1 mL in 1 SYRINGE (58160-821-05)

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