NDC 63459-912-36 Granix

Tbo-filgrastim

  1. Labeler Index
  2. Cephalon, Inc.
  3. 63459-912
  4. NDC Package Code: 63459-912-36 Granix

NDC Package Code 63459-912-36

The NDC Code 63459-912-36 is assigned to a package of 5 syringe, glass in 1 carton > .8 ml in 1 syringe, glass (63459-912-18) of Granix, a human prescription drug labeled by Cephalon, Inc.. 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 4.0 billable units per package.

Field Name Field Value
NDC Code 63459-912-36
Package Description 5 SYRINGE, GLASS in 1 CARTON > .8 mL in 1 SYRINGE, GLASS (63459-912-18)
Proprietary Name Granix 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.
Non-Proprietary Name Tbo-filgrastim 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.
Drug Uses 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 63459091236 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.
Billing Unit ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Estimated Billable Units per Package 4.0 ML
RxNorm Crosswalk1433768, 1433771, 1442681, 1442683 and 2101456 - RxCUI What is RxNorm?
The RxNorm crosswalk provides a normalized naming system for generic and branded drugs by assigning unique concept identifiers (RxCUI) to each NDC.
Product Type Human Prescription Drug 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.
Labeler Name Cephalon, Inc.
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)
  • FILGRASTIM 480 ug/.8mL
Pharmacological Class(es)
  • Granulocyte Colony-Stimulating Factor - [CS]
  • Granulocyte-Macrophage Colony-Stimulating Factor - [CS]
  • Increased Myeloid Cell Production - [PE] (Physiologic Effect)
  • Leukocyte Growth Factor - [EPC] (Established Pharmacologic Class)
Sample Package No Sample Package?
This field Indicates whether this package is a sample packaging or not.
Marketing Category BLA - A product marketed under an approved Biologic License Application. 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.
FDA Application Number BLA125294 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.
Start Marketing Date 11-11-2013 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date 12-31-2022 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.
Exclude Flag N 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".

NDC Code Structure

  • 63459 - Cephalon, Inc.
    • 63459-912 - Granix
      • 63459-912-36 - 5 SYRINGE, GLASS 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 63459-912-36 HCPCS crosswalk information with package details and bill units information.

NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
63459091236J1447Inj tbo filgrastim 1 microg1 MCG0.854802400

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Other Product Packages

The following packages are also available for Granix with product NDC 63459-912.

NDC Package CodePackage Description
63459-912-111 BLISTER PACK in 1 CARTON > 1 SYRINGE, GLASS in 1 BLISTER PACK (63459-912-12) > .8 mL in 1 SYRINGE, GLASS (63459-912-01)
63459-912-1510 BLISTER PACK in 1 CARTON > 1 SYRINGE, GLASS in 1 BLISTER PACK (63459-912-12) > .8 mL in 1 SYRINGE, GLASS (63459-912-01)
63459-912-171 SYRINGE, GLASS in 1 CARTON > .8 mL in 1 SYRINGE, GLASS (63459-912-18)

* Please review the disclaimer below.