NDC 49643-342 Standardized Bermuda 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:
49643-342
Proprietary Name:
Standardized Bermuda Grass
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Allermed Laboratories, Inc.
Labeler Code:
49643
Start Marketing Date: [9]
12-02-1996
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Packages

NDC Code 49643-342-05

Package Description: 5 mL in 1 VIAL, MULTI-DOSE

NDC Code 49643-342-10

Package Description: 10 mL in 1 VIAL, MULTI-DOSE

NDC Code 49643-342-30

Package Description: 30 mL in 1 VIAL, MULTI-DOSE

NDC Code 49643-342-50

Package Description: 50 mL in 1 VIAL, MULTI-DOSE

Product Details

What is NDC 49643-342?

The NDC code 49643-342 is assigned by the FDA to the product Standardized Bermuda Grass which is product labeled by Allermed Laboratories, Inc.. The product's dosage form is . The product is distributed in 4 packages with assigned NDC codes 49643-342-05 5 ml in 1 vial, multi-dose , 49643-342-10 10 ml in 1 vial, multi-dose , 49643-342-30 30 ml in 1 vial, multi-dose , 49643-342-50 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 Standardized Bermuda Grass?

Standardized grass pollen extract is indicated for use in the diagnosis of grass allergy in patients with a history of allergic symptoms that occur during grass pollination. Skin tests with standardized grass pollen extract should be done first by the puncture method using 10,000 BAU/mL extract. If these tests are negative, they may be repeated by the puncture method with 100,000 BAU/mL extract, or by the intradermal method using an appropriate dilution (see DOSAGE AND ADMINISTRATION). The extract also is indicated for use in the treatment of allergic symptoms by immunotherapy in patients with a history of grass pollen allergy and established sensitivity to grass pollen extract by skin testing. The availability of 10,000 and 100,000 BAU/mL extracts facilitates dose selection for safe switching to standardized grass pollen extracts. Previously untreated patients should be initially treated with appropriately diluted 10,000 BAU/mL. If tolerated, higher doses may be indicated. The use of grass pollen extract for the above purposes should be made only by physicians with special familiarity and knowledge of allergy as described in a standard allergy textbook13. Allermed's standardized grass pollen extracts labeled in BAU/mL are not interchangeable with alum-precipitated grass pollen extracts, grass pollen extracts labeled in AU/mL or non-standardized grass pollen extracts.

Which are Standardized Bermuda Grass 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)

Which are Standardized Bermuda 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 Bermuda 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: 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

* Please review the disclaimer below.

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".