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  5. NDC Package Code: 22840-0038-8 Standardized Mite Dermatophagoides Farinae

NDC Package 22840-0038-8 Standardized Mite Dermatophagoides Farinae

Dermatophagoides Farinae Concentrate Intradermal; Percutaneous; Subcutaneous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
22840-0038-8
Package Description:
30 mL in 1 VIAL, MULTI-DOSE
Product Code:
22840-0038
Proprietary Name:
Standardized Mite Dermatophagoides Farinae
Non-Proprietary Name:
Dermatophagoides Farinae
Substance Name:
Dermatophagoides Farinae
Usage Information:
Greer Standardized Mite (Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated forskin test diagnosis of mite allergytreatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.For immunotherapy, patients must show hypersensitivity to Dermatophagoides farinae (D. farinae) or Dermatophagoides pteronyssinus (D. pteronyssinus) based on their clinical history, allergen exposure history, and skin test reactivity.
11-Digit NDC Billing Format:
22840003808
NDC to RxNorm Crosswalk:
  • RxCUI: 1014384 - European house dust mite extract 5000 AU/ML Injectable Solution
  • RxCUI: 1014384 - European house dust mite allergenic extract 5000 AU/ML Injectable Solution
  • RxCUI: 1014384 - Dermatophagoides pteronyssinus extract 5,000 AU/ML Injectable Solution
  • RxCUI: 1192764 - American house dust mite allergenic extract 15,000 AU/mL / European house dust mite allergenic extract 15,000 AU/mL Injectable Solution
  • RxCUI: 1192764 - American house dust mite allergenic extract 15000 AU/ML / European house dust mite allergenic extract 15000 AU/ML Injectable Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Greer Laboratories, Inc.
    Dosage Form:
    Concentrate - A liquid preparation of increased strength and reduced volume which is usually diluted prior to administration.
    Administration Route(s):
  • Intradermal - Administration within the dermis.
  • Percutaneous - Administration through the skin.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    • Active Ingredient(s):
  • DERMATOPHAGOIDES FARINAE 30000 [AU]/mL
    • Pharmacologic Class(es):
  • Allergens - [CS]
  • Antigens, Dermatophagoides - [CS]
  • Cell-mediated Immunity - [PE] (Physiologic Effect)
  • Increased Histamine Release - [PE] (Physiologic Effect)
  • Increased IgG Production - [PE] (Physiologic Effect)
  • Insect Proteins - [CS]
  • Standardized Insect Allergenic Extract - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    BLA101834
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    02-03-2010
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    22840-0038-610 mL in 1 VIAL, MULTI-DOSE
    22840-0038-950 mL in 1 VIAL, MULTI-DOSE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 22840-0038-8?

    The NDC Packaged Code 22840-0038-8 is assigned to a package of 30 ml in 1 vial, multi-dose of Standardized Mite Dermatophagoides Farinae, a human prescription drug labeled by Greer Laboratories, Inc.. The product's dosage form is concentrate and is administered via intradermal; percutaneous; subcutaneous form.

    Is NDC 22840-0038 included in the NDC Directory?

    Yes, Standardized Mite Dermatophagoides Farinae with product code 22840-0038 is active and included in the NDC Directory. The product was first marketed by Greer Laboratories, Inc. on February 03, 2010 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 22840-0038-8?

    The 11-digit format is 22840003808. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-4-122840-0038-85-4-222840-0038-08