Fludrocortisone Acetate
NDC Package 49349-556-20

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.

Fludrocortisone Acetate is fludrocortisone is a man-made form of a natural substance (glucocorticoid) made by the body. Marketed by Remedyrepack Inc., this product is identified by NDC 49349-556 and is authorized under FDA application ANDA040425.

Identification & Billing

NDC Package Code
49349-556-20
Package Description
100 TABLET in 1 CANISTER
Product Code
49349-556
11-Digit Billing Format
49349055620

Clinical Specifications

Proprietary Name
Fludrocortisone Acetate
Dosage Form
-
Usage Information
Fludrocortisone is a man-made form of a natural substance (glucocorticoid) made by the body. It is used along with other medications (e.g., hydrocortisone) to treat low glucocorticoid levels caused by disease of the adrenal gland (e.g., Addison's disease, adrenocortical insufficiency, salt-losing adrenogenital syndrome). Glucocorticoids are needed in many ways for the body to function well. They are important for salt and water balance and keeping blood pressure normal. They are also needed to break down carbohydrates in your diet.

Regulatory & Marketing

Labeler Name
Remedyrepack Inc.
FDA Application #
ANDA040425
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-03-2011
End Marketing Date
10-03-2012
Listing Expiration
10-03-2012
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 49349-556-20 identifies a specific commercial package of 100 tablet in 1 canister of Fludrocortisone Acetate, labeled by Remedyrepack 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 Remedyrepack Inc. on October 03, 2011. The current certification is valid through October 03, 2012.

What are the primary indications for this medication?

Fludrocortisone is a man-made form of a natural substance (glucocorticoid) made by the body. It is used along with other medications (e.g., hydrocortisone) to treat low glucocorticoid levels caused by disease of the adrenal gland (e.g., Addison's disease, adrenocortical insufficiency, salt-losing adrenogenital syndrome). Glucocorticoids are needed in many ways for the body to function well. They are important for salt and water balance and keeping blood pressure normal. They are also needed to break down carbohydrates in your diet.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49349055620. 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)
49349-556-20
11-Digit CMS (5-4-2)
49349-0556-20

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