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  4. NDC Product Code: 54575-908 Quaking Aspen Pollen

NDC 54575-908 Quaking Aspen Pollen

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 54575-908?
  4. Quaking Aspen Pollen Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Get all the details for National Drug Code (NDC) 54575-908 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
54575-908
Proprietary Name:
Quaking Aspen Pollen
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Allergy Laboratories, Inc.
Labeler Code:
54575
Product Label ID:
c1114779-3e11-47ab-8889-f534406f4041
FDA Application Number: [6]
BLA101376
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date: [9]
12-07-1967
Listing Expiration Date: [11]
12-31-2018
Exclude Flag: [12]
I
Code Navigator:

Code Structure Chart

Product Details

What is NDC 54575-908?

The NDC code 54575-908 is assigned by the FDA to the product Quaking Aspen Pollen which is product labeled by Allergy Laboratories, Inc.. The product's dosage form is . The product is distributed in 4 packages with assigned NDC codes 54575-908-02 2 ml in 1 vial, multi-dose , 54575-908-10 10 ml in 1 vial, multi-dose , 54575-908-30 30 ml in 1 vial, multi-dose , 54575-908-50 50 ml in 1 vial, multi-dose . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Quaking Aspen Pollen?

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 Quaking Aspen Pollen UNII Codes?

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

Which are Quaking Aspen Pollen Inactive Ingredients 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:

What is the NDC to RxNorm Crosswalk for Quaking Aspen Pollen?

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 Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] 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.

[8] 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.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] 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.

[12] 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".