Intrarosa
NDC Package 69110-001-01

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.

Intrarosa is a medication used by women after menopause to treat painful sexual intercourse. Marketed by Endoceutics Inc., this product is identified by NDC 69110-001 and is authorized under FDA application NDA208470.

Identification & Billing

NDC Package Code
69110-001-01
Package Description
1 BOX in 1 BOX / 28 BLISTER PACK in 1 BOX / 1 INSERT in 1 BLISTER PACK
Product Code
69110-001
11-Digit Billing Format
69110000101

Clinical Specifications

Proprietary Name
Intrarosa
Dosage Form
-
Usage Information
This medication is used by women after menopause to treat painful sexual intercourse. Painful intercourse can be a symptom of changes in and around your vagina, due to menopause. Prasterone belongs to a class of drugs known as steroids. It is not well understood how it works to lessen painful intercourse, but prasterone is changed in the body to certain hormones (androgens and estrogens).

Regulatory & Marketing

Labeler Name
Endoceutics Inc.
FDA Application #
NDA208470
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-19-2017
End Marketing Date
07-19-2017
Listing Expiration
07-19-2017
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 69110-001-01 identifies a specific commercial package of 1 box in 1 box / 28 blister pack in 1 box / 1 insert in 1 blister pack of Intrarosa, labeled by Endoceutics 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 Endoceutics Inc. on July 19, 2017. The current certification is valid through July 19, 2017.

What are the primary indications for this medication?

This medication is used by women after menopause to treat painful sexual intercourse. Painful intercourse can be a symptom of changes in and around your vagina, due to menopause. Prasterone belongs to a class of drugs known as steroids. It is not well understood how it works to lessen painful intercourse, but prasterone is changed in the body to certain hormones (androgens and estrogens).

How is this Endoceutics Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69110000101. 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)
69110-001-01
11-Digit CMS (5-4-2)
69110-0001-01

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