NDC 58160-964-12 Rabavert

Rabies Vaccine

NDC Package Code 58160-964-12

Field Name Field Value
NDC Code 58160-964-12
Package Description 1 KIT in 1 CARTON * 1 mL in 1 VIAL, GLASS (58160-966-01) * 1 mL in 1 SYRINGE (58160-967-02)
Proprietary Name Rabavert 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 Rabies Vaccine 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 58160096412 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 EA - Billing unit of "each" is used when the product is dispensed in discreet units.
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 Kit - A packaged collection of related material.
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 BLA103334 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 12-19-2016 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 58160-964-12 is assigned to Rabavert, a vaccine lable labeled by Glaxosmithkline Biologicals Sa. The product's dosage form is kit and is administered via form.


Code Structure
  • 58160 - Glaxosmithkline Biologicals Sa
    • 58160-964 - Rabavert
      • 58160-964-12 - 1 KIT in 1 CARTON * 1 mL in 1 VIAL, GLASS (58160-966-01) * 1 mL in 1 SYRINGE (58160-967-02)

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 58160-964-12 HCPCS crosswalk information with package details and bill units information.

NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
5816009641290675Rabies vaccine im1 ML1111

* Please review the disclaimer below.

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