Omalizumab Injection, Solution
NDC 17088-0386
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.
Omalizumab is a DRUG FOR FURTHER PROCESSING-approved product labeled by Novartis Pharma Stein Ag. Omalizumab is used to control and prevent symptoms (such as wheezing and shortness of breath) caused by asthma that is due to year-round allergens. It is supplied as a injection, solution. This product entry covers the primary NDC 17088-0386 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
17088-0386
Proprietary Name:
Omalizumab
Non-Proprietary Name: [1]
Omalizumab
Substance Name: [2]
Omalizumab
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
UNFINISHED PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
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.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
17088
Marketing Category: [8]
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Marketing Timeline
Start Marketing Date: [9]
06-20-2003
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N
Unfinished Product: [13]
Yes
Code Structure Chart
Product Details
What is NDC 17088-0386?
The NDC code 17088-0386 is assigned by the FDA to the product Omalizumab. It is commonly known by its generic name, omalizumab. This pharmaceutical product is labeled by Novartis Pharma Stein Ag and is currently categorized as listed product. The medication is a injection, solution. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 17088-0386-1. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
Omalizumab is used to control and prevent symptoms (such as wheezing and shortness of breath) caused by asthma that is due to year-round allergens. Controlling symptoms of asthma helps you maintain your normal activities and cuts down on time lost from work or school. Omalizumab is also used to treat hives from an unknown cause (chronic idiopathic urticaria-CIU). This medication must be used regularly to be effective. It does not work right away. If an asthma attack occurs, use your quick-relief inhaler (such as albuterol, salbutamol) as prescribed.
What are Active Ingredients of this product?
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.
- OMALIZUMAB 150 mg/1.2mL - An anti-IgE, recombinant, humanized monoclonal antibody which specifically binds to the C epsilon3 domain of IMMUNOGLOBULIN E, the site of high-affinity IgE receptor binding. It inhibits the binding of IgE to MAST CELLS and BASOPHILS to reduce the severity of the allergic response and is used in the management of persistent allergic ASTHMA.
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Product & Regulatory Definitions
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.
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.
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.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
What is an Unfinished Product? This field indicates if the product is an unfinished drug. An unfinished drug is an active pharmaceutical ingredient either alone or with other ingredients that is not a finished drug product. Unfinished drugs are used to process other drugs or for drug compounding.
