Midwest Molds
NDC Package 0268-8039-50

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Midwest Molds is hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust, molds, animal danders, various other inhalants, and in situations where the offending allergen cannot be avoided.Prior to initiation of therapy, the clinical sensitivity should be established by careful evaluation of the patient’s history confirmed by diagnostic skin testing. Marketed by Alk-abello, Inc., this product is identified by NDC 0268-8039 and is authorized under FDA application BLA103753.

Identification & Billing

NDC Package Code
0268-8039-50
Package Description
53 mL in 1 VIAL
Product Code
0268-8039
11-Digit Billing Format
00268803950
RxNorm Crosswalk
  • RxCUI: 1922788 - giant ragweed pollen extract 100 UNT/ML / short ragweed pollen extract 100 UNT/ML Injectable Solution
  • RxCUI: 1922788 - Ambrosia artemisiifolia pollen extract 100 PNU/ML / Ambrosia trifida pollen extract 100 PNU/ML Injectable Solution
  • RxCUI: 1922788 - Ambrosia artemisiifolia pollen extract 100 UNT/ML / Ambrosia trifida pollen extract 100 UNT/ML Injectable Solution
  • RxCUI: 1922791 - giant ragweed pollen extract 40000 UNT/ML / short ragweed pollen extract 40000 UNT/ML Injectable Solution
  • RxCUI: 1922791 - Ambrosia artemisiifolia pollen extract 40000 PNU/ML / Ambrosia trifida pollen extract 40000 PNU/ML Injectable Solution

Clinical Specifications

Proprietary Name
Midwest Molds
Dosage Form
-
Usage Information
Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust, molds, animal danders, various other inhalants, and in situations where the offending allergen cannot be avoided.Prior to initiation of therapy, the 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 easily be avoided.

Regulatory & Marketing

Labeler Name
Alk-abello, Inc.
FDA Application #
BLA103753
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
01-01-1965
End Marketing Date
05-24-2023
Listing Expiration
05-24-2023
Exclude Flag
D
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0268-8039-50 identifies a specific commercial package of 53 ml in 1 vial of Midwest Molds, labeled by Alk-abello, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Alk-abello, Inc. on January 01, 1965. The current certification is valid through May 24, 2023.

How is this Alk-abello, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00268803950. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0268-8039-50
11-Digit CMS (5-4-2)
00268-8039-50

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.