Intrarosa Insert
NDC Package 72495-401-28

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

Package Information

Intrarosa (prasterone) inserts is a medication used by women after menopause to treat painful sexual intercourse. This formulation utilizes a insert delivery system. Marketed by Millicent Us, Inc., this product is identified by NDC 72495-401 and is authorized under FDA application NDA208470.

Identification & Billing

NDC Package Code
72495-401-28
Package Description
1 BOX in 1 BOX / 28 BLISTER PACK in 1 BOX / 1 INSERT in 1 BLISTER PACK
Product Code
72495-401
11-Digit Billing Format
72495040128
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Intrarosa
Non-Proprietary Name
Prasterone
Substance Name
Prasterone
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)
PRASTERONE 6.5 mg/1
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
Millicent Us, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA208470
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-01-2020
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 72495-401-28 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, a human prescription drug labeled by Millicent Us, Inc.. This insert is formulated for vaginal use and contains prasterone 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 Millicent Us, Inc. on November 01, 2020. The current certification is valid through December 31, 2026.

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 Millicent Us, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72495040128. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
72495-401-28
11-Digit CMS (5-4-2)
72495-0401-28

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