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  5. NDC Package Code: 55607-400-10 Prastera

NDC Package 55607-400-10 Prastera

View Billable Units, 11-Digit Format, RxNorm

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.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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
Proprietary Name:
Prastera
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.
11-Digit NDC Billing Format:
55607040010
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
  • RxCUI: 197805 - ibuprofen 400 MG Oral Tablet
    • Labeler Name:
    Health Science Funding, Llc
    Sample Package:
    No
    Start Marketing Date:
    04-04-2014
    Listing Expiration Date:
    12-31-2018
    Exclude Flag:
    I
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 55607-400-10?

    The NDC Packaged Code 55607-400-10 is assigned to a 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. The product's dosage form is and is administered via form.

    Is NDC 55607-400 included in the NDC Directory?

    No, Prastera with product code 55607-400 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Health Science Funding, Llc on April 04, 2014 and its listing in the NDC Directory is set to expire on December 31, 2018 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 55607-400-10?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units.

    What is the 11-digit format for NDC 55607-400-10?

    The 11-digit format is 55607040010. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-255607-400-105-4-255607-0400-10