NDC 36987-1083 Horse Epithelium

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:
36987-1083
Proprietary Name:
Horse Epithelium
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Code:
36987
FDA Application Number: [6]
BLA102192
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date: [9]
08-29-1972
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
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Product Details

What is NDC 36987-1083?

The NDC code 36987-1083 is assigned by the FDA to the product Horse Epithelium 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 36987-1083-1 5 ml in 1 vial, multi-dose , 36987-1083-2 10 ml in 1 vial, multi-dose , 36987-1083-3 30 ml in 1 vial, multi-dose , 36987-1083-4 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 Horse Epithelium?

Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.

Which are Horse Epithelium UNII Codes?

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

Which are Horse Epithelium 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 Horse Epithelium?

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: 889656 - hog skin extract 20000 UNT/mL Injectable Solution
  • RxCUI: 889656 - hog skin extract 20000 UNT/ML Injectable Solution
  • RxCUI: 889656 - Sus scrofa skin extract 20,000 UNT/ML Injectable Solution
  • RxCUI: 894778 - duck feather extract 20,000 UNT/mL Injectable Solution
  • RxCUI: 894778 - duck feather extract 20000 UNT/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 ("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".