Armarita
NDC Package 53028-1001-2

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.

Armarita is 1. Marketed by Jg Select Inc, this product is identified by NDC 53028-1001 and is authorized under FDA application part333D.

Identification & Billing

NDC Package Code
53028-1001-2
Package Description
5 SYRINGE, PLASTIC in 1 CARTON / 3 mL in 1 SYRINGE, PLASTIC (53028-1001-1)
Product Code
53028-1001
11-Digit Billing Format
53028100102

Clinical Specifications

Proprietary Name
Armarita
Dosage Form
-
Usage Information
1. after washing your hands, take the product out of the protective wrapper2. snap off the tip to reveal opening3. hold the outer insertion tube where it meets the inner tube, with your thumb and middle finger4. inert the smooth head of the applicator into your vagina until you fingers touch your body (applicator should be about 3 inches inside your vagina)5. push the product inside by pushing the inner tube with your pointer finger all the way in6. remove the applicator, that's it!7. dispose empty applicator in trash

Regulatory & Marketing

Labeler Name
Jg Select Inc
FDA Application #
part333D
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
08-02-2012
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 53028-1001-2 identifies a specific commercial package of 5 syringe, plastic in 1 carton / 3 ml in 1 syringe, plastic (53028-1001-1) of Armarita, labeled by Jg Select Inc. 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 Jg Select Inc on August 02, 2012. The current certification is valid through December 31, 2017.

How is this Jg Select Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53028100102. 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)
53028-1001-2
11-Digit CMS (5-4-2)
53028-1001-02

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