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  4. NDC Product Code: 49288-0341 Standardized Orchard Grass Pollen

NDC 49288-0341 Standardized Orchard Grass Pollen

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 49288-0341?
  4. Standardized Orchard Grass 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) 49288-0341 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:
49288-0341
Proprietary Name:
Standardized Orchard Grass Pollen
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Antigen Laboratories, Inc.
Labeler Code:
49288
Product Label ID:
c08f73ff-4f15-449c-9507-c422367f106b
FDA Application Number: [6]
BLA102228
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date: [9]
06-13-1997
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
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Product Details

What is NDC 49288-0341?

The NDC code 49288-0341 is assigned by the FDA to the product Standardized Orchard Grass Pollen which is product labeled by Antigen Laboratories, Inc.. The product's dosage form is . The product is distributed in 4 packages with assigned NDC codes 49288-0341-2 5 ml in 1 vial, multi-dose , 49288-0341-3 10 ml in 1 vial, multi-dose , 49288-0341-4 30 ml in 1 vial, multi-dose , 49288-0341-5 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 Standardized Orchard Grass Pollen?

INDICATIONS AND USAGE     Allergenic extract is indicated for diagnostic testing and treatment (immunotherapy) of patients whose histories indicate allergic symptoms upon natural exposure to grass allergens. Confirmation is determined by skin testing. 10,000 BAU/ml extracts are intended for percutaneous testing. If negative, 100,000 BAU/ml products can be used for percutaneous test. Dilutions made from 10,000 BAU/ml products are indicated for immunotherapy of previously untreated patients. If 10,000 BAU/ml product is tolerated and symptoms persist, dilutions made from 100,000 BAU/ml can be administered. Standardized Grass Pollen extracts labeled in Bioequivalent Allergy Units (BAU/ml) are not interchangeable with grass pollen extracts labeled In Allergy Units (AU/ml) or with non-standardized grass pollen extracts.

Which are Standardized Orchard Grass Pollen 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)

Which are Standardized Orchard Grass 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 Standardized Orchard Grass 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: 851873 - redtop grass pollen extract 100000 BAU/ML Injectable Solution
  • RxCUI: 851873 - Agrostis gigantea pollen extract 100,000 BAU/ML Injectable Solution
  • RxCUI: 852157 - Timothy grass pollen extract 100000 BAU/mL Injectable Solution
  • RxCUI: 852157 - Timothy grass pollen extract 100000 BAU/ML Injectable Solution
  • RxCUI: 852157 - Phleum pratense grass pollen extract 100,000 BAU/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".