3-oak Mix, Black/blackjack/post Pollen
NDC 54575-953
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.
3-oak Mix, Black/blackjack/post Pollen is a BLA-approved product labeled by Allergy 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 54575-953 and 4 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
54575-953
Proprietary Name:
3-oak Mix, Black/blackjack/post Pollen
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
54575
Product Label ID:
FDA Application Number: [6]
BLA101376
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Marketing Timeline
Start Marketing Date: [9]
12-07-1967
Listing Expiration Date: [11]
12-31-2018
Exclude Flag: [12]
I
Code Structure Chart
Product Details
What is NDC 54575-953?
The NDC code 54575-953 is assigned by the FDA to the product 3-oak Mix, Black/blackjack/post Pollen. This pharmaceutical product is labeled by Allergy Laboratories, Inc. and is currently categorized as listed product. In terms of distribution, this product is available in 4 different package configurations. The associated package NDC(s) include: 54575-953-02, 54575-953-10, 54575-953-30, 54575-953-50. 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?
Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It 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:
- QUERCUS VELUTINA POLLEN (UNII: 294L626TT0)
- QUERCUS VELUTINA POLLEN (UNII: 294L626TT0) (Active Moiety)
- QUERCUS NIGRA POLLEN (UNII: 6U600U1326)
- QUERCUS NIGRA POLLEN (UNII: 6U600U1326) (Active Moiety)
- QUERCUS STELLATA POLLEN (UNII: W34X0P8636)
- QUERCUS STELLATA POLLEN (UNII: W34X0P8636) (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:
- SODIUM CHLORIDE (UNII: 451W47IQ8X)
- SODIUM BICARBONATE (UNII: 8MDF5V39QO)
- WATER (UNII: 059QF0KO0R)
- 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: 1000013 - whole wheat allergenic extract 50 MG/ML Injectable Solution
- RxCUI: 1000013 - whole wheat allergenic extract 0.05 GM/ML Injectable Solution
- RxCUI: 1000013 - whole wheat extract 50 MG/ML Injectable Solution
- RxCUI: 1006300 - Aspergillus niger var. niger allergenic extract 50 MG/ML Injectable Solution
- RxCUI: 1006300 - Aspergillus niger var. niger allergenic extract 0.05 GM/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".
