NDC 65044-0720 Standardized Grass Pollen, Orchard Grass

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
65044-0720
Proprietary Name:
Standardized Grass Pollen, Orchard Grass
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Jubilant Hollisterstier Llc
Labeler Code:
65044
Start Marketing Date: [9]
01-15-1998
Listing Expiration Date: [11]
12-31-2019
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Packages

NDC Code 65044-0720-5

Package Description: 5 mL in 1 VIAL

Product Details

What is NDC 65044-0720?

The NDC code 65044-0720 is assigned by the FDA to the product Standardized Grass Pollen, Orchard Grass which is product labeled by Jubilant Hollisterstier Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 65044-0720-5 5 ml in 1 vial . 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 Grass Pollen, Orchard Grass?

16, 17, 18, 20Standardized glycerinated allergenic extracts in potencies of 10,000 BAU/mL and 100,000 BAU/mL are indicated for use in diagnosis and immunotherapy of patients presenting symptoms of allergy (hay fever, rhinitis, etc.) to specific grass pollens. Concentrated extracts must be diluted prior to use in intradermal testing and immunotherapy. The selection of allergenic extracts to be used should be based on a thorough and carefully taken history of hypersensitivity, and confirmed by skin testing. 27, 28 10,000 BAU/mL dose form should be used initially for percutaneous testing. If negative, the 100,000 BAU/mL dose can be used.The use of mixed or unrelated antigens for skin testing is not recommended since, in the case of a positive reaction, it does not indicate which component of the mix is responsible for the reaction, while, in the case of a negative reaction, it fails to indicate whether the individual antigens at full concentration would give a positive reaction. Utilization of such mixes for compounding a treatment may result, in the former case, in administering unnecessary antigens and, in the latter case, in the omission of a needed allergen. Allergens to which a patient is extremely sensitive should not be included in treatment mixes with allergens to which there is much less sensitivity, but should be administered separately. This allows individualized and better control of dosage increases, including adjustments in dosage becoming necessary after severe reactions which may occur to the highly reactive allergen. Note: BAU/mL Standardized grass pollens are not interchangeable with any other grass pollen products.

Which are Standardized Grass Pollen, Orchard Grass UNII Codes?

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

  • POA PRATENSIS POLLEN (UNII: SCB8J7LS3T)
  • POA PRATENSIS POLLEN (UNII: SCB8J7LS3T) (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 Grass Pollen, Orchard Grass 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 Grass Pollen, Orchard Grass?

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: 853988 - Bermuda grass pollen extract 100 BAU/ML Injectable Solution
  • RxCUI: 853988 - Cynodon dactylon pollen extract 100 BAU/ML Injectable Solution
  • RxCUI: 853990 - orchard grass pollen extract 100 BAU/ML Injectable Solution
  • RxCUI: 853990 - Dactylis glomerata pollen extract 100 BAU/ML Injectable Solution
  • RxCUI: 853992 - orchard grass pollen extract 1000 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.

[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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".