Treatment Set Ts335683
NDC 49288-0781
View NDC Profile UNII Mappings and RxNorm Concepts.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
Treatment Set Ts335683 is a BLA-approved product labeled by Antigen Laboratories, Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a product. This product entry covers the primary NDC 49288-0781 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
49288-0781
Proprietary Name:
Treatment Set Ts335683
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
49288
Product Label ID:
FDA Application Number: [6]
BLA102223
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Marketing Timeline
Start Marketing Date: [9]
10-31-1986
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure Chart
Product Details
What is NDC 49288-0781?
The NDC code 49288-0781 is assigned by the FDA to the product Treatment Set Ts335683. This pharmaceutical product is labeled by Antigen Laboratories, Inc. and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 49288-0781-3. 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?
When the natural exposure to elevated aeroallergens produces symptoms as described under Clinical Pharmacology, specific diagnosis and therapeutic procedures are indicated. Clearly, important clues to the cause of a person's allergic condition can be gleaned from a thorough history and careful physical examination. Diagnostic tests - in vitro or in vivo - serve only to confirm the physician's suspicions or to improve investigative skills. Specific diagnosis is especially indicated when the patient's symptoms are not controlled by medication. When immunotherapy is contemplated demonstration of sensitivity to a specific allergenic extract is necessary. An orderly approach to the use of diagnostic tests usually begins with direct skin testing. 5,6,11THIS PRODUCT IS NOT INTENDED FOR TREATMENT OF PATIENTS WHO DO NOT MANIFEST IMMEDIATE HYPERSENSITIVITY REACTIONS TO THE ALLERGENIC EXTRACT FOLLOWING SKIN TESTING.
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)
- 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:
- PHENOL (UNII: 339NCG44TV)
- WATER (UNII: 059QF0KO0R)
- SODIUM CHLORIDE (UNII: 451W47IQ8X)
- SODIUM BICARBONATE (UNII: 8MDF5V39QO)
- GLYCERIN (UNII: PDC6A3C0OX)
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: 1192754 - Bermuda grass pollen extract 2000 BAU/mL / Timothy grass pollen extract 20000 BAU/mL Injectable Solution
- RxCUI: 1192754 - Bermuda grass pollen extract 2000 BAU/ML / Timothy grass pollen extract 20000 BAU/ML Injectable Solution
- RxCUI: 1192754 - Cynodon dactylon pollen extract 2,000 BAU/ML / Phleum pratense pollen extract 20,000 BAU/ML Injectable Solution
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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".
