Nucala Injection, Solution
NDC 0173-0892
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Nucala (mepolizumab) is a BLA-approved product labeled by Glaxosmithkline Llc. This medication is used along with other medications to control and prevent symptoms (such as wheezing and shortness of breath) caused by asthma. It is supplied as a injection, solution for subcutaneous administration. This product entry covers the primary NDC 0173-0892 and 4 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
0173-0892
Proprietary Name:
Nucala
Non-Proprietary Name: [1]
Mepolizumab
Substance Name: [2]
Mepolizumab
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE 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.
Administration Route(s): [4]
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
0173
Product Label ID:
HCPCS Code:
J2182
- INJECTION, MEPOLIZUMAB, 1 MG
FDA Application Number: [6]
BLA761122
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Marketing Timeline
Start Marketing Date: [9]
06-06-2019
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 0173-0892?
The NDC code 0173-0892 is assigned by the FDA to the product Nucala. It is commonly known by its generic name, mepolizumab. This pharmaceutical product is labeled by Glaxosmithkline Llc and is currently categorized as listed product. The medication is a injection, solution administered via subcutaneous route. In terms of distribution, this product is available in 4 different package configurations. The associated package NDC(s) include: 0173-0892-01, 0173-0892-42, 0173-0892-61, 0173-0892-63. 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?
This medication is used along with other medications to control and prevent symptoms (such as wheezing and shortness of breath) caused by asthma. Controlling symptoms of asthma helps you do your normal activities and decreases time lost from work or school. Mepolizumab works by reducing swelling (inflammation) of the airways in the lungs to make breathing easier. Mepolizumab is also used to treat a certain immune system diseases (eosinophilic granulomatosis with polyangiitis-EGPA, hypereosinophilic syndrome-HES). It helps to control and prevent symptoms (such as wheezing, shortness of breath, runny nose, facial pain, tiredness) caused by these diseases. It works by decreasing the amount of certain white blood cells (eosinophils) which may cause these diseases. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden asthma attacks or breathing problems. If an asthma attack occurs, use your quick-relief inhaler 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.
- MEPOLIZUMAB 100 mg/mL - a humanized monoclonal antibody to IL-5 in cynomolgus monkeys
What is the NDC to RxNorm Crosswalk for this product?
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:
- RxCUI: 1720601 - mepolizumab 100 MG Injection
- RxCUI: 1720606 - Nucala 100 MG Injection
- RxCUI: 1720606 - mepolizumab 100 MG Injection [Nucala]
- RxCUI: 2170990 - mepolizumab 100 MG in 1 mL Auto-Injector
- RxCUI: 2170990 - 1 ML mepolizumab 100 MG/ML Auto-Injector
Which are the Pharmacologic Classes of this product?
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
Mepolizumab Injection
Mepolizumab injection is used along with other medications to prevent wheezing, difficulty breathing, chest tightness, and coughing caused by asthma in certain children 6 years of age and older and adults whose asthma is not controlled with their current asthma medication(s). Mepolizumab injection is also used along with other medications to treat chronic rhinosinusitis with nasal polyps (ongoing runny nose, sinus swelling or nasal congestion, with or without a reduced sense of smell or pain and pressure in the face) in adults whose symptoms are not controlled with other medications. It is also used to treat eosinophilic granulomatosis with polyangiitis (EGPA; a condition that involves asthma, high levels of white blood cells, and blood vessel swelling) in adults. Mepolizumab injection is also used to treat hypereosinophilic syndrome (HES; group of blood disorders that occurs with high levels of certain white blood cells) in adults and children 12 years and older who have had this condition for 6 months or longer. Mepolizumab injection is in a class of medications called monoclonal antibodies. It works by blocking the action of a certain natural substance in the body that causes the symptoms of asthma.
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* Please review the full disclaimer at the bottom of this page.
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 are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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".
