Vagisten-v Cream
NDC Package 69729-612-05

11-digit billing NDC: 69729061205
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Vagisten-v (miconazole nitrate) cream is bEFORE USING THIS PRODUCT READ THE ENCLOSED CONSUMER INFORMATION LEAFLET FOR COMPLETE DIRECTIONS AND INFORMATIONADULTS AND CHILDREN 12 YEARS OF AGE OR OVER:APPLICATOR: INSERT 1 APPLICATOR INTO THE VAGINA AT BEDTIME FOR 7 NIGHTS IN A ROW. This formulation utilizes a cream delivery system. Marketed by Opmx Llc, this product is identified by NDC 69729-612 and is authorized under FDA application M005.

Identification & Billing

NDC Package Code
69729-612-05
Package Description
1 TUBE in 1 BOX / 14 g in 1 TUBE (69729-612-01)
Product Code
69729-612
11-Digit Billing Format
69729061205
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Vagisten-v 7 Day
Non-Proprietary Name
Miconazole Nitrate
Substance Name
Miconazole Nitrate
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route
Vaginal - Administration into the vagina.
Active Ingredient(s)
MICONAZOLE NITRATE 2 g/100g
Pharmacologic Class
Usage Information
BEFORE USING THIS PRODUCT READ THE ENCLOSED CONSUMER INFORMATION LEAFLET FOR COMPLETE DIRECTIONS AND INFORMATIONADULTS AND CHILDREN 12 YEARS OF AGE OR OVER:APPLICATOR: INSERT 1 APPLICATOR INTO THE VAGINA AT BEDTIME FOR 7 NIGHTS IN A ROW. THROW APPLICATOR AWAY AFTER USE.EXTERNAL CREAM: USE THE SAME TUBE OF CREAM IF YOU HAVE ITCHING AND IRRITATION ON THE SKIN OUTSIDE THE VAGINA. SQUEEZE A SMALL AMOUNT OF CREAM ONTO YOUR FINGERTIP. APPLY TO ITCHY, IRRITATED SKIN OUTSIDE THE VAGINA (VULVA). USE 2 TIMES DAILY FOR UP TO 7 DAYS AS NEEDED.CHILDREN UNDER 12 YEARS OF AGE: ASK A DOCTOR.

Regulatory & Marketing

Labeler Name
Opmx Llc
Product Type
Human Otc Drug
FDA Application #
M005
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-05-2018
Listing Expiration
12-31-2026
Exclude Flag
N
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 69729-612-05 identifies a specific commercial package of 1 tube in 1 box / 14 g in 1 tube (69729-612-01) of Vagisten-v 7 Day, a human over the counter drug labeled by Opmx Llc. This cream is formulated for vaginal 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 Opmx Llc on September 05, 2018. The current certification is valid through December 31, 2026.

How is this Opmx Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69729061205. 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)
69729-612-05
11-Digit CMS (5-4-2)
69729-0612-05

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