Pollens - Trees, Boxelder/maple Mix
NDC 65044-1215

View NDC Profile UNII Mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 65044-1215?
  4. Pollens - Trees, Boxelder/maple Mix Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Pollens - Trees, Boxelder/maple Mix is a BLA-approved product labeled by Jubilant Hollisterstier Llc. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a product. This product entry covers the primary NDC 65044-1215 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
65044-1215
Proprietary Name:
Pollens - Trees, Boxelder/maple Mix
Product Type: [3]
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Jubilant Hollisterstier Llc
Labeler Code:
65044
Product Label ID:
d756bf9e-2e57-48a4-897a-ec1d96472dec
FDA Application Number: [6]
BLA103888
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.

Marketing Timeline

Start Marketing Date: [9]
04-19-1941
End Marketing Date: [10]
01-01-2014
Listing Expiration Date: [11]
01-01-2014
Exclude Flag: [12]
D

Code Structure Chart

Product Details

What is NDC 65044-1215?

The NDC code 65044-1215 is assigned by the FDA to the product Pollens - Trees, Boxelder/maple Mix. This pharmaceutical product is labeled by Jubilant Hollisterstier Llc 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: 65044-1215-5. 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?

Certain diagnostics carry labeling which states Allergenic Extract for Diagnostic Use Only. Data to support the therapeutic use of products labeled with this statement have not been established.15In addition to a carefully taken history, the use of intradermal testing extracts is an accepted method in the diagnosis of allergenic conditions.1, 2, 3 When scratch, prick or puncture reactions are small, or if the patient gives a history of allergic symptoms to a substance but scratch, prick or puncture tests are inconclusive, intradermal tests may be indicated. However, ANTIGENS PRODUCING LARGE 3 TO 4+ SCRATCH, PRICK OR PUNCTURE TESTS SHOULD NOT BE TESTED INTRADERMALLY. Extracts of all allergens do not produce equivalent results in intradermal testing. The intensity of the skin reaction produced will be determined by two factors: the degree of sensitivity of the patient and the nature of the antigenic extract applied. In general, pollen extracts produce whealing reactions, whereas other inhalants produce erythematous reactions with wheals less often. Skin tests to foods seldom produce whealing reactions except for infrequent instances of severe sensitivity to fish, nuts or spices, and rarely other foods.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

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:

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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 End Marketing Date? This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
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".