Clotrimazole Cream, 1%
NDC Package 85633-004-01

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.

Clotrimazole Cream, 1% is a . Marketed by Estiva Generics Corporation, this product is identified by NDC 85633-004 and is authorized under FDA application M005.

Identification & Billing

NDC Package Code
85633-004-01
Package Description
30 g in 1 TUBE
Product Code
85633-004
11-Digit Billing Format
85633000401
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
30 GM

Clinical Specifications

Proprietary Name
Clotrimazole Cream, 1%
Dosage Form
-

Regulatory & Marketing

Labeler Name
Estiva Generics Corporation
FDA Application #
M005
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-19-2025
End Marketing Date
03-10-2026
Listing Expiration
03-10-2026
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 85633-004-01 identifies a specific commercial package of 30 g in 1 tube of Clotrimazole Cream, 1%, labeled by Estiva Generics Corporation. 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 Estiva Generics Corporation on May 19, 2025. The current certification is valid through March 10, 2026.

How is this Estiva Generics Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85633000401. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 30 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)
85633-004-01
11-Digit CMS (5-4-2)
85633-0004-01

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