Vagical Insert
NDC Package 68984-001-10

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Vagical (calendula officinalis flowering top) inserts is adults 18 years and up: Wash hands before and after use. This formulation utilizes a insert delivery system. Marketed by Farmina Sp. Z O.o., this product is identified by NDC 68984-001.

Identification & Billing

NDC Package Code
68984-001-10
Package Description
10 INSERT in 1 PACKAGE
Product Code
68984-001
11-Digit Billing Format
68984000110

Clinical Specifications

Proprietary Name
Vagical
Non-Proprietary Name
Calendula Officinalis Flowering Top
Substance Name
Calendula Officinalis Flowering Top
Dosage Form
Insert - A specially formulated and shaped non-encapsulated solid preparation intended to be placed into a non-rectal orifice of the body, where drug is released, generally for localized effects.
Administration Route
Vaginal - Administration into the vagina.
Active Ingredient(s)
CALENDULA OFFICINALIS FLOWERING TOP 150 mg/1
Usage Information
Adults 18 years and up: Wash hands before and after use. Before use, damp insert with water that has been previously boiled and cooled. Place one insert into vagina 2-3 times per day.Children 12-18 years: Consult a doctor before use.Under 12 years of age: Do not use

Regulatory & Marketing

Labeler Name
Farmina Sp. Z O.o.
Product Type
Human Otc Drug
Marketing Category
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Start Marketing Date
05-29-2014
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 68984-001-10 identifies a specific commercial package of 10 insert in 1 package of Vagical, a human over the counter drug labeled by Farmina Sp. Z O.o.. This insert is formulated for vaginal use and contains calendula officinalis flowering top 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 Farmina Sp. Z O.o. on May 29, 2014. The current certification is valid through December 31, 2026.

How is this Farmina Sp. Z O.o. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68984000110. 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)
68984-001-10
11-Digit CMS (5-4-2)
68984-0001-10

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