NDC 63459-918 Granix
Tbo-filgrastim Injection, Solution Subcutaneous - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 63459 - Cephalon, Llc
- 63459-918 - Granix
Product Packages
NDC Code 63459-918-59
Package Description: 10 VIAL in 1 CARTON / 1 mL in 1 VIAL (63459-918-53)
Product Details
What is NDC 63459-918?
What are the uses for Granix?
What are Granix Active Ingredients?
- FILGRASTIM 300 ug/mL - A recombinant granulocyte colony-stimulating factor (G-CSF) that is used in the treatment and prevention of NEUTROPENIA, preparation and collection of blood progenitor cells, and for use in PERIPHERAL BLOOD STEM CELL TRANSPLANTATION.
What is the NDC to RxNorm Crosswalk for Granix?
- 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
Which are the Pharmacologic Classes for Granix?
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Patient Education
Filgrastim Injection
Filgrastim injection products (Granix, Neupogen, Nivestym, Releuko, Zarxio) are used to decrease the chance of infection in people who have non myeloid cancer (cancer that does not involve the bone marrow) and are receiving chemotherapy medications that may decrease the number of neutrophils (a type of blood cell needed to fight infection). Filgrastim injection products (Neupogen, Nivestym, Releuko, Zarxio) are also used to help increase the number of white blood cells, and decrease the length of time with fever in people with acute myeloid leukemia (AML; a type of cancer of the white blood cells) who are receiving treatment with chemotherapy medications. Filgrastim injection products (Neupogen, Nivestym, Releuko, Zarxio) are also used in people who are undergoing bone marrow transplants and in people who have severe chronic neutropenia (condition in which there are a low number of neutrophils in the blood). Filgrastim injection products (Neupogen, Nivestym, Zarxio) are also used to prepare the blood for leukapheresis (a treatment in which certain blood cells are removed from the body. Filgrastim injection (Neupogen) is also used to increase the chance of survival in people who have been exposed to harmful amounts of radiation, which can cause severe and life-threatening damage to your bone marrow. Filgrastim is in a class of medications called colony-stimulating factors. It works by helping the body make more neutrophils.
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* Please review the disclaimer below.
[1] 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.
[2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
[3] 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.
[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.
[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.
[6] 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.
[8] 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.
[9] 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] 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] 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".