NDC 0024-5862 Mozobil
Plerixafor Injection, Solution Subcutaneous

Table of Contents

    1. Product Information
    2. Product Packages
    3. What is NDC 0024-5862?
    4. Mozobil Uses
    5. Active Ingredients
    6. Active Ingredients UNII Codes
    7. Inactive Ingredients UNII Codes
    8. NDC to RxNorm Crosswalk
    9. Pharmacologic Classes
    10. Patient Education

Product Information

NDC Product Code0024-5862
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.		Mozobil
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.		Plerixafor
Substance Name 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.		Plerixafor
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
NDC Directory StatusACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage FormInjection, 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) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Sanofi-aventis U.s. Llc
Labeler Code0024
SPL SET ID:0ed08d2b-5051-46b2-aa37-1d6275bf9003
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.		NDA022311
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.		NDA - A product marketed under an approved New Drug Application.
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.		09-01-2013
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.		12-31-2024
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

Product Packages

NDC Code 0024-5862-01

Package Description: 1 VIAL, SINGLE-USE in 1 CARTON / 1.2 mL in 1 VIAL, SINGLE-USE

Product Details

What is NDC 0024-5862?

The NDC code 0024-5862 is assigned by the FDA to the product Mozobil which is a human prescription drug product labeled by Sanofi-aventis U.s. Llc. The generic name of Mozobil is plerixafor. The product's dosage form is injection, solution and is administered via subcutaneous form. The product is distributed in a single package with assigned NDC code 0024-5862-01 1 vial, single-use in 1 carton / 1.2 ml in 1 vial, single-use. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Mozobil?

Plerixafor is used by patients with certain types of cancer (non-Hodgkin's lymphoma-NHL, multiple myeloma-MM) to prepare them for stem cell transplant. Stem cells, which are found mainly in the bone marrow, turn into red blood cells, white blood cells, and platelets. Plerixafor is used to help stem cells move from the bone marrow to the bloodstream so that the cells can be collected and stored. The stem cells are then infused back into the patient after chemotherapy or radiation.

What are Mozobil Active Ingredients?

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.

Which are Mozobil UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Mozobil Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Mozobil?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Which are the Pharmacologic Classes for Mozobil?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Patient Education

Plerixafor Injection


Plerixafor injection is used along with a granulocyte-colony stimulating factor (G-CSF) medication such as filgrastim (Neupogen) or pegfilgrastim (Neulasta) to prepare the blood for an autologous stem cell transplant (procedure in which certain blood cells are removed from the body and then returned to the body after chemotherapy and/or radiation) in patients with non-Hodgkin's lymphoma (NHL; cancer that begins in a type of white blood cells that normally fights infection) or multiple myeloma (a type of cancer of the bone marrow). Plerixafor injection is in a class of medications called hematopoeitic stem cell mobilizers. It works by causing certain blood cells to move from the bone marrow to the blood so that they can be removed for transplant.
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Product Label

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