Miconazole Nitrate
NDC Package 21695-854-45

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 inactivated by the FDA.

Miconazole Nitrate is before using this product read the enclosed consumerinformation leaflet for complete instructions. Marketed by Rebel Distributors Corp, this product is identified by NDC 21695-854 and is authorized under FDA application part333C.

Identification & Billing

NDC Package Code
21695-854-45
Package Description
45 g in 1 TUBE
Product Code
21695-854
11-Digit Billing Format
21695085445
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
45 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Miconazole Nitrate
Dosage Form
-
Usage Information
. before using this product read the enclosed consumerinformation leaflet for complete instructions. adults and children 12 years of age and over: . applicator: insert one applicatorful into the vagina at bedtime for 7 nights in a row. external cream: squeeze a small amount of cream onto your fingertip.Gently apply the cream onto the itchy, irritated skin outside thevagina. Use daily for up to 7 days as needed. children under 12 years of age: ask a doctor

Regulatory & Marketing

Labeler Name
Rebel Distributors Corp
FDA Application #
part333C
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
01-01-2008
Listing Expiration
12-31-2017
Exclude Flag
I
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 21695-854-45 identifies a specific commercial package of 45 g in 1 tube of Miconazole Nitrate, labeled by Rebel Distributors Corp. This product is billed per "GM" gram and contains an estimated amount of 45 billable units per package. 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 Rebel Distributors Corp on January 01, 2008. The current certification is valid through December 31, 2017.

How is this Rebel Distributors Corp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 21695085445. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 45 total billable units per package. 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)
21695-854-45
11-Digit CMS (5-4-2)
21695-0854-45

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