Standardized Grass Pollen, Timothy Injection, Solution
NDC 65044-0832
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Standardized Grass Pollen, Timothy is a BLA-approved product labeled by Jubilant Hollisterstier Llc. This medication is typically used as a allergens [cs]. It is supplied as a injection, solution for percutaneous; subcutaneous administration. This product entry covers the primary NDC 65044-0832 and 8 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
65044-0832
Proprietary Name:
Standardized Grass Pollen, Timothy
Non-Proprietary Name: [1]
Standardized Grass Pollen, Timothy
Substance Name: [2]
Phleum Pratense Pollen
NDC Directory Status:
Standardized Allergenic
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]
- Percutaneous - Administration through the skin.
- Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
65044
Product Label ID:
FDA Application Number: [6]
BLA103879
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Marketing Timeline
Start Marketing Date: [9]
01-15-1998
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 65044-0832?
The NDC code 65044-0832 is assigned by the FDA to the product Standardized Grass Pollen, Timothy. This pharmaceutical product is labeled by Jubilant Hollisterstier Llc and is currently categorized as listed product. The medication is a injection, solution administered via percutaneous; subcutaneous route. In terms of distribution, this product is available in 8 different package configurations. 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?
16, 17, 18, 20 Standardized glycerinated allergenic extracts in potencies of 10,000 BAU/mL and 100,000 BAU/mL are indicated for use in diagnosis and immunotherapy of patients presenting symptoms of allergy (hay fever, rhinitis, etc.) to specific grass pollens. Concentrated extracts must be diluted prior to use in intradermal testing and immunotherapy. The selection of allergenic extracts to be used should be based on a thorough and carefully taken history of hypersensitivity, and confirmed by skin testing. 27, 28 10,000 BAU/mL dose form should be used initially for percutaneous testing. If negative, the 100,000 BAU/mL dose can be used.The use of mixed or unrelated antigens for skin testing is not recommended since, in the case of a positive reaction, it does not indicate which component of the mix is responsible for the reaction, while, in the case of a negative reaction, it fails to indicate whether the individual antigens at full concentration would give a positive reaction. Utilization of such mixes for compounding a treatment may result, in the former case, in administering unnecessary antigens and, in the latter case, in the omission of a needed allergen. Allergens to which a patient is extremely sensitive should not be included in treatment mixes with allergens to which there is much less sensitivity, but should be administered separately. This allows individualized and better control of dosage increases, including adjustments in dosage becoming necessary after severe reactions which may occur to the highly reactive allergen. Note: BAU/mL Standardized grass pollens are not interchangeable with any other grass pollen products.
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.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- CYNODON DACTYLON POLLEN (UNII: 175F461W10)
- CYNODON DACTYLON POLLEN (UNII: 175F461W10) (Active Moiety)
- FESTUCA PRATENSIS POLLEN (UNII: A0WFQ8P6N1)
- FESTUCA PRATENSIS POLLEN (UNII: A0WFQ8P6N1) (Active Moiety)
- DACTYLIS GLOMERATA POLLEN (UNII: 83N78IDA7P)
- DACTYLIS GLOMERATA POLLEN (UNII: 83N78IDA7P) (Active Moiety)
- AGROSTIS GIGANTEA POLLEN (UNII: HU8V6E7HOA)
- AGROSTIS GIGANTEA POLLEN (UNII: HU8V6E7HOA) (Active Moiety)
- LOLIUM PERENNE POLLEN (UNII: 4T81LB52R0)
- LOLIUM PERENNE POLLEN (UNII: 4T81LB52R0) (Active Moiety)
- ANTHOXANTHUM ODORATUM POLLEN (UNII: 2KIK19R45Y)
- ANTHOXANTHUM ODORATUM POLLEN (UNII: 2KIK19R45Y) (Active Moiety)
- 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:
- GLYCERIN (UNII: PDC6A3C0OX)
- SODIUM CHLORIDE (UNII: 451W47IQ8X)
- SODIUM BICARBONATE (UNII: 8MDF5V39QO)
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: 851873 - redtop grass pollen extract 100000 BAU/ML Injectable Solution
- RxCUI: 851873 - Agrostis gigantea pollen extract 100,000 BAU/ML Injectable Solution
- RxCUI: 851881 - orchard grass pollen extract 10000 BAU/ML Injectable Solution
- RxCUI: 851881 - Dactylis glomerata pollen extract 10,000 BAU/ML Injectable Solution
- RxCUI: 851901 - sweet vernal grass pollen extract 10000 BAU/ML Injectable Solution
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".
