Grastek
NDC 52709-1501
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
Grastek is a BLA-approved product labeled by Alk-abello A S. This medication is used to treat certain allergies that may occur seasonally or year round. It is supplied as a white product. This product entry covers the primary NDC 52709-1501 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
52709-1501
Proprietary Name:
Grastek
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
52709
Product Label ID:
FDA Application Number: [6]
BLA125473
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Marketing Timeline
Start Marketing Date: [9]
04-11-2014
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
I
Product Characteristics
Color(s):
WHITE (C48325 - WHITE TO OFF-WHITE)
Shape:
ROUND (C48348)
Size(s):
13 MM
Score:
1
Code Structure Chart
Product Details
What is NDC 52709-1501?
The NDC code 52709-1501 is assigned by the FDA to the product Grastek. This pharmaceutical product is labeled by Alk-abello A S and is currently categorized as listed product. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 52709-1501-3, 52709-1501-5. 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 to treat certain allergies that may occur seasonally or year round. It is an extract of certain plant pollens that can cause allergies. Before prescribing this medication, your doctor must do laboratory/medical tests (such as skin or IgE tests) to learn what you are allergic to. This pollen allergen extract works by making your body less sensitive to the pollens (such as ragweed, grasses) that cause your allergies. This medication will not work right away to relieve allergy symptoms. When taken as directed, it may help relieve symptoms such as sneezing, runny/stuffy nose, cough, or itchy/watery eyes that are caused by allergies.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- PHLEUM PRATENSE POLLEN (UNII: 65M88RW2EG)
- PHLEUM PRATENSE POLLEN (UNII: 65M88RW2EG) (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:
- MARINE COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W)
- MANNITOL (UNII: 3OWL53L36A)
- SODIUM HYDROXIDE (UNII: 55X04QC32I)
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: 1495309 - Timothy grass pollen extract 2800 BAU Sublingual Tablet
- RxCUI: 1495316 - Grastek 2800 BAU Sublingual Tablet
- RxCUI: 1495316 - Timothy grass pollen extract 2800 BAU Sublingual Tablet [Grastek]
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Product & Regulatory Definitions
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".
