NDC 63459-910-11 Granix
Tbo-filgrastim Injection, Solution Subcutaneous

Package Information

The NDC Code 63459-910-11 is assigned to a package of 1 blister pack in 1 carton > 1 syringe, glass in 1 blister pack (63459-910-12) > .5 ml in 1 syringe, glass (63459-910-01) of Granix, a human prescription drug labeled by Cephalon, Llc. The product's dosage form is injection, solution and is administered via subcutaneous form.This product is billed per "ML" milliliter and contains an estimated amount of 0.5 billable units per package.

Field Name Field Value
NDC Code 63459-910-11
Package Description 1 BLISTER PACK in 1 CARTON > 1 SYRINGE, GLASS in 1 BLISTER PACK (63459-910-12) > .5 mL in 1 SYRINGE, GLASS (63459-910-01)
Product Code 63459-910
Proprietary Name What 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.
Granix
Non-Proprietary Name What 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.
Tbo-filgrastim
Usage Information Product Usage Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.
Filgrastim is a man-made version of a certain natural substance made in your body. It is used to help your body make more white blood cells. White blood cells are important to help you fight off infections. Filgrastim is given to people whose ability to make white blood cells is reduced (for instance, due to chemotherapy, chronic neutropenia, or exposure to large amounts of radiation). It is also used in certain treatment procedures (such as bone marrow/stem cell transplant). This monograph is about the following filgrastim products: filgrastim, tbo-filgrastim, filgrastim-sndz, and filgrastim-aafi.
11-Digit NDC Billing Format NDC 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.
63459091011
Billing Unit ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Estimated Billable Units per Package 0.5 ML
NDC to RxNorm Crosswalk
  • RxCUI: 1433768 - tbo-filgrastim 300 MCG in 0.5 ML Prefilled Syringe
  • RxCUI: 1433768 - 0.5 ML tbo-filgrastim 0.6 MG/ML Prefilled Syringe
  • RxCUI: 1433768 - tbo-filgrastim 300 MCG per 0.5 ML Prefilled Syringe
  • RxCUI: 1433771 - tbo-filgrastim 480 MCG per 0.8 ML Prefilled Syringe
  • RxCUI: 1433771 - 0.8 ML tbo-filgrastim 0.6 MG/ML Prefilled Syringe
  • Product Type What 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.
    Human Prescription Drug
    Labeler Name Cephalon, Llc
    Dosage Form Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
    Administration Route(s)
    • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    Active Ingredient(s)
    Pharmacologic Class(es)
    Sample Package Sample Package?
    This field Indicates whether this package is a sample packaging or not.
    No
    Marketing Category What 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.
    BLA - A product marketed under an approved Biologic License Application.
    FDA Application Number What 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.
    BLA125294
    Start Marketing Date What is the Start Marketing Date?
    This is the date that the labeler indicates was the start of its marketing of the drug product.
    11-11-2013
    Listing Expiration Date What is the Listing Expiration Date?
    This is the date when the listing record will expire if not updated or certified by the product labeler.
    12-31-2023
    Exclude Flag What is the NDC Exclude Flag?
    This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
    N
    NDC Code Structure

    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.

    * Please review the disclaimer below.

    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 63459-910-11 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    63459091011J1447Inj tbo filgrastim 1 microg1 MCG0.51300300

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for Granix with product NDC 63459-910.

    NDC Package CodePackage Description
    63459-910-1510 BLISTER PACK in 1 CARTON > 1 SYRINGE, GLASS in 1 BLISTER PACK (63459-910-12) > .5 mL in 1 SYRINGE, GLASS (63459-910-01)
    63459-910-171 SYRINGE, GLASS in 1 CARTON > .5 mL in 1 SYRINGE, GLASS (63459-910-18)
    63459-910-365 SYRINGE, GLASS in 1 CARTON > .5 mL in 1 SYRINGE, GLASS (63459-910-18)

    * Please review the disclaimer below.