Miconazole Nitrate Suppository
NDC Package 65655-0013-1

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Miconazole Nitrate suppositories is a medication used to treat vaginal yeast infections. This formulation utilizes a suppository delivery system. Marketed by Swiss Caps Ag, this product is identified by NDC 65655-0013.

Identification & Billing

NDC Package Code
65655-0013-1
Package Description
2 BAG in 1 CARTON / 1200 SUPPOSITORY in 1 BAG
Product Code
65655-0013
11-Digit Billing Format
65655001301

Clinical Specifications

Proprietary Name
Miconazole Nitrate
Non-Proprietary Name
Miconazole Nitrate
Substance Name
Miconazole Nitrate
Dosage Form
Suppository - A solid body of various weights and shapes, adapted for introduction into the rectal orifice of the human body; they usually melt, soften, or dissolve at body temperature.
Active Ingredient(s)
MICONAZOLE NITRATE 1200 mg/1
Usage Information
This medication is used to treat vaginal yeast infections. Miconazole reduces vaginal burning, itching, and discharge that may occur with this condition. This medication is an azole antifungal. It works by stopping the growth of yeast (fungus) that causes the infection. The vaginal product comes in 2 forms (a vaginal cream or tablet). Some products also come with a skin cream to be applied to the area around the outside of the vagina. Ask your doctor before using this medication for self-treatment if this is your first vaginal infection. This medication only works for vaginal fungal infections. You may have a different type of infection (such as bacterial vaginosis) and may need a different medication. If you have fever, chills, flu-like symptoms, stomach/abdominal pain, or a bad-smelling vaginal discharge, do not use this medication. Contact your doctor right away because these may be signs of a more serious infection.

Regulatory & Marketing

Labeler Name
Swiss Caps Ag
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
06-29-2001
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 65655-0013-1 identifies a specific commercial package of 2 bag in 1 carton / 1200 suppository in 1 bag of Miconazole Nitrate (UNFINISHED drug), drug for further processing labeled by Swiss Caps Ag. This suppository is formulated for use and contains miconazole nitrate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Swiss Caps Ag on June 29, 2001. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat vaginal yeast infections. Miconazole reduces vaginal burning, itching, and discharge that may occur with this condition. This medication is an azole antifungal. It works by stopping the growth of yeast (fungus) that causes the infection. The vaginal product comes in 2 forms (a vaginal cream or tablet). Some products also come with a skin cream to be applied to the area around the outside of the vagina. Ask your doctor before using this medication for self-treatment if this is your first vaginal infection. This medication only works for vaginal fungal infections. You may have a different type of infection (such as bacterial vaginosis) and may need a different medication. If you have fever, chills, flu-like symptoms, stomach/abdominal pain, or a bad-smelling vaginal discharge, do not use this medication. Contact your doctor right away because these may be signs of a more serious infection.

How is this Swiss Caps Ag product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65655001301. 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 (5-4-1)
65655-0013-1
11-Digit CMS (5-4-2)
65655-0013-01

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