Derofen Miel
NDC Package 81660-435-01

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.

Derofen Miel is therapeutic indications: Indicated for the symptomatic treatment of manifestations related to allergic rhinitis such as: sneezing, runny nose and watery eyes. Marketed by Grimann, S.a. De C.v., this product is identified by NDC 81660-435 and is authorized under FDA application part349.

Identification & Billing

NDC Package Code
81660-435-01
Package Description
1 U in 1 BOTTLE, GLASS
Product Code
81660-435
11-Digit Billing Format
81660043501

Clinical Specifications

Proprietary Name
Derofen Miel
Dosage Form
-
Usage Information
Therapeutic indications: Indicated for the symptomatic treatment of manifestations related to allergic rhinitis such as: sneezing, runny nose and watery eyes. Also indicated for chronic hives and other manifestations of allergic dermatological disorder

Regulatory & Marketing

Labeler Name
Grimann, S.a. De C.v.
FDA Application #
part349
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
05-05-2021
End Marketing Date
02-03-2023
Listing Expiration
02-03-2023
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 81660-435-01 identifies a specific commercial package of 1 u in 1 bottle, glass of Derofen Miel, labeled by Grimann, S.a. De C.v.. 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 Grimann, S.a. De C.v. on May 05, 2021. The current certification is valid through February 03, 2023.

How is this Grimann, S.a. De C.v. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81660043501. 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 (5-3-2)
81660-435-01
11-Digit CMS (5-4-2)
81660-0435-01

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