Prastera
NDC Package 55607-400-10

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.

Prastera is oral prasterone (200mg per day) in female patients with active systemic lupus erythematosus (SLE) has in several blinded, placebo-controlled randomized clinical studies been associated with a reduced risk of auto-immune flare, §§6.2, 14.1.1, a reduced risk of breast cancer and a reduced risk of death from any cause, §§6.4, 14.2. Marketed by Health Science Funding, Llc, this product is identified by NDC 55607-400.

Identification & Billing

NDC Package Code
55607-400-10
Package Description
1 KIT in 1 KIT * 15 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 5 TABLET in 1 BLISTER PACK
Product Code
55607-400
11-Digit Billing Format
55607040010
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk
RxCUI: 197805 - ibuprofen 400 MG Oral Tablet

Clinical Specifications

Proprietary Name
Prastera
Dosage Form
-
Usage Information
Oral prasterone (200mg per day) in female patients with active systemic lupus erythematosus (SLE) has in several blinded, placebo-controlled randomized clinical studies been associated with a reduced risk of auto-immune flare, §§6.2, 14.1.1, a reduced risk of breast cancer and a reduced risk of death from any cause, §§6.4, 14.2. Patients with SLE may have depressed serum levels of 5-dehydroepiandrosterone sulfate (5-DHEAS). Oral prasterone has been shown to restore SLE patients' serum 5-DHEAS levels. Prastera® oral softgels are intended for use in patients for whom medical evaluation shows a depressed serum level of DHEA and thus a distinctive need for exogenous DHEA. Prastera® oral prasterone softgels are intended to be used under medical supervision, for a patient receiving active and ongoing medical supervision, wherein the patient obtains medical care on a recurring basis for, among other things, instructions on the use of this product. Prastera® oral prasterone softgels are intended for the dietary management of SLE by meeting the distinctive nutritional requirement of women with mild-to-moderate active SLE. Prastera® oral prasterone softgels are intended for oral intake only. Prastera® does not cure, treat, mitigate or prevent SLE. To the contrary, patients taking Prastera® will continue to have SLE, and thus may continue to require other appropriate therapy.

Regulatory & Marketing

Labeler Name
Health Science Funding, Llc
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
04-04-2014
Listing Expiration
12-31-2018
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 55607-400-10 identifies a specific commercial package of 1 kit in 1 kit * 15 capsule, liquid filled in 1 blister pack * 5 tablet in 1 blister pack of Prastera, labeled by Health Science Funding, Llc. 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 Health Science Funding, Llc on April 04, 2014. The current certification is valid through December 31, 2018.

How is this Health Science Funding, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55607040010. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
55607-400-10
11-Digit CMS (5-4-2)
55607-0400-10

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