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  5. NDC Package Code: 0268-0277-50 Standardized Mite D. Pteronyssinus

NDC Package 0268-0277-50 Standardized Mite D. Pteronyssinus

Injection, Solution 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:
0268-0277-50
Package Description:
50 mL in 1 VIAL, MULTI-DOSE
Product Code:
0268-0277
Proprietary Name:
Standardized Mite D. Pteronyssinus
Non-Proprietary Name:
Standardized Mite D. Pteronyssinus
Substance Name:
Dermatophagoides Pteronyssinus
Usage Information:
This product is indicated for the diagnosis and treatment of hypersensitivity in patients with symptoms compatible with dust mite allergy.Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust mites, molds, animal danders, and various other inhalants, in situations where the offending allergen cannot be avoided. Mixtures of standardized mite (D. farinae and D. pteronyssinus) should be considered for treatment of patients who are sensitive to both species.Prior to the initiation of therapy, clinical sensitivity should be established by careful evaluation of the patient's history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can be easily avoided.
11-Digit NDC Billing Format:
00268027750
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
50 ML
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: 852813 - American house dust mite extract 5000 AU/ML Injectable Solution
  • RxCUI: 852813 - American house dust mite allergenic extract 5000 AU/ML Injectable Solution
    • Product Type:
    Standardized Allergenic
    Labeler Name:
    Alk-abello, Inc.
    Dosage Form:
    Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
    Administration Route(s):
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    • Active Ingredient(s):
  • DERMATOPHAGOIDES PTERONYSSINUS 10000 [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:
    BLA103752
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    08-14-1990
    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
    0268-0277-1010 mL in 1 VIAL, MULTI-DOSE
    0268-0277-3030 mL in 1 VIAL, MULTI-DOSE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0268-0277-50?

    The NDC Packaged Code 0268-0277-50 is assigned to a package of 50 ml in 1 vial, multi-dose of Standardized Mite D. Pteronyssinus, a standardized allergenic label labeled by Alk-abello, Inc.. The product's dosage form is injection, solution and is administered via subcutaneous form.This product is billed per "ML" milliliter and contains an estimated amount of 50 billable units per package.

    Is NDC 0268-0277 included in the NDC Directory?

    Yes, Standardized Mite D. Pteronyssinus with product code 0268-0277 is active and included in the NDC Directory. The product was first marketed by Alk-abello, Inc. on August 14, 1990 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 NDC billing unit for package 0268-0277-50?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 50.

    What is the 11-digit format for NDC 0268-0277-50?

    The 11-digit format is 00268027750. 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 4-4-2 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
    4-4-20268-0277-505-4-200268-0277-50