Intrarosa
NDC Package 64011-601-28
Package Information
Intrarosa is a medication used by women after menopause to treat painful sexual intercourse. Marketed by Amag Pharmaceuticals, Inc., this product is identified by NDC 64011-601 and is authorized under FDA application NDA208470.
Identification & Billing
- RxCUI: 1927688 - prasterone 6.5 MG Vaginal Insert
- RxCUI: 1927688 - dehydroepiandrosterone (prasterone) 6.5 MG Vaginal Insert
- RxCUI: 1927693 - Intrarosa 6.5 MG Vaginal Insert
- RxCUI: 1927693 - prasterone 6.5 MG Vaginal Insert [Intrarosa]
- RxCUI: 1927693 - Intrarosa (prasterone) 6.5 MG Vaginal Insert
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 64011 - Amag Pharmaceuticals, Inc.
- 64011-601 - Intrarosa
- 64011-601-28 - 1 BOX in 1 BOX / 28 BLISTER PACK in 1 BOX / 1 INSERT in 1 BLISTER PACK
- 64011-601 - Intrarosa
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.
Other Available Packages
The following commercial packages are registered under the same Product NDC (64011-601). Click a package code to view its specific billing and regulatory data.
* 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 64011-601-28 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, labeled by Amag Pharmaceuticals, 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 Amag Pharmaceuticals, Inc. on July 24, 2017. The current certification is valid through December 31, 2021.
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 Amag Pharmaceuticals, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 64011060128. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
