Drax Exametazime Injection, Powder, Lyophilized, For Solution
NDC 65174-200
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Drax Exametazime (kit for the preparation of technetium tc 99m exametazime for leukocyte labeling) is a NDA-approved product labeled by Jubilant Draximage Inc., Dba Jubilant Radiopharma. This medication is typically used as a radioactive diagnostic agent [epc]. It is supplied as a injection, powder, lyophilized, for solution for intravenous administration. This product entry covers the primary NDC 65174-200 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
65174-200
Proprietary Name:
Drax Exametazime
Non-Proprietary Name: [1]
Kit For The Preparation Of Technetium Tc 99m Exametazime For Leukocyte Labeling
Substance Name: [2]
Technetium Tc-99m Exametazime
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Injection, Powder, Lyophilized, For Solution
- A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route(s): [4]
Intravenous - Administration within or into a vein or veins.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
65174
Product Label ID:
FDA Application Number: [6]
NDA208870
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
08-17-2017
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 65174-200?
The NDC code 65174-200 is assigned by the FDA to the product Drax Exametazime. It is commonly known by its generic name, kit for the preparation of technetium tc 99m exametazime for leukocyte labeling. This pharmaceutical product is labeled by Jubilant Draximage Inc., Dba Jubilant Radiopharma and is currently categorized as listed product. The medication is a injection, powder, lyophilized, for solution administered via intravenous route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 65174-200-05. 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?
Drax Exametazime is indicated for leukocyte (white blood cell) labeled scintigraphy as an adjunct in the localization of intra-abdominal infection and inflammatory bowel disease.
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.
- TECHNETIUM TC-99M EXAMETAZIME .5 mg/1 - A gamma-emitting RADIONUCLIDE IMAGING agent used in the evaluation of regional cerebral blood flow and in non-invasive dynamic biodistribution studies and MYOCARDIAL PERFUSION IMAGING. It has also been used to label leukocytes in the investigation of INFLAMMATORY BOWEL DISEASES.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- TECHNETIUM TC-99M EXAMETAZIME (UNII: 3B744AG22N)
- TECHNETIUM TC-99M EXAMETAZIME (UNII: 3B744AG22N) (Active Moiety)
Which are the Inactive Ingredients associated 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:
- STANNOUS CHLORIDE (UNII: 1BQV3749L5)
- SODIUM CHLORIDE (UNII: 451W47IQ8X)
- NITROGEN (UNII: N762921K75)
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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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".
