NDC 36987-1845 Standardized Mite Dermatophagoides Pteronyssinus

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:
36987-1845
Proprietary Name:
Standardized Mite Dermatophagoides Pteronyssinus
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Nelco Laboratories, Inc.
Labeler Code:
36987
Start Marketing Date: [9]
02-22-1990
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Packages

NDC Code 36987-1845-1

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

NDC Code 36987-1845-2

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

NDC Code 36987-1845-3

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

NDC Code 36987-1845-4

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

Product Details

What is NDC 36987-1845?

The NDC code 36987-1845 is assigned by the FDA to the product Standardized Mite Dermatophagoides Pteronyssinus which is product labeled by Nelco Laboratories, Inc.. The product's dosage form is . The product is distributed in 4 packages with assigned NDC codes 36987-1845-1 5 ml in 1 vial, multi-dose , 36987-1845-2 10 ml in 1 vial, multi-dose , 36987-1845-3 30 ml in 1 vial, multi-dose , 36987-1845-4 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 Mite Dermatophagoides Pteronyssinus?

Standardized mite allergenic extracts are intended for use in the diagnosis and therapy of D.farinae and D.pteronyssinus mite allergy, as established by allergy history and skin test reactivity (6,10). Standardized Mite extracts are not interchangeable with non standardized mite extracts. To select patients for a confirmation of allergic disease diagnosis and/or treatment with allergen extracts, screening tests should be done using in vivo identification testing methods (i.e. scratch or intradermal testing).(13)Standardized mite extract containing equal parts of D.farinae and D.pteronyssinus is intended for therapy only. The use of standardized mites extract is indicated for hypersensitization treatment and may be used as part of the over-all management of the allergic patient. This treatment is particularly to be recommended when a patient's sensitivity to mite has been determined initially by scratch or intradermal skin tests.

Which are Standardized Mite Dermatophagoides Pteronyssinus UNII Codes?

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

  • DERMATOPHAGOIDES FARINAE (UNII: PR9U2YPF3Q)
  • DERMATOPHAGOIDES FARINAE (UNII: PR9U2YPF3Q) (Active Moiety)
  • DERMATOPHAGOIDES PTERONYSSINUS (UNII: 57L1Z5378K)
  • DERMATOPHAGOIDES PTERONYSSINUS (UNII: 57L1Z5378K) (Active Moiety)

Which are Standardized Mite Dermatophagoides Pteronyssinus 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 Mite Dermatophagoides Pteronyssinus?

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: 852825 - American house dust mite extract 10000 AU/ML Injectable Solution
  • RxCUI: 852825 - American house dust mite allergenic extract 10000 AU/ML Injectable Solution
  • RxCUI: 852825 - Dermatophagoides farinae extract 10,000 AU/ML Injectable Solution
  • RxCUI: 852829 - European house dust mite extract 10000 AU/ML Injectable Solution
  • RxCUI: 852829 - European house dust mite allergenic extract 10000 AU/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".