Fludrocortisone Acetate
NDC Package 63629-7780-2

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. 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 Bryant Ranch Prepack, this product is identified by NDC 63629-7780 and is authorized under FDA application ANDA040425.

Identification & Billing

NDC Package Code
63629-7780-2
Package Description
60 TABLET in 1 BOTTLE
Product Code
63629-7780
11-Digit Billing Format
63629778002

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
Bryant Ranch Prepack
FDA Application #
ANDA040425
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-14-2003
End Marketing Date
12-30-2022
Listing Expiration
12-30-2022
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (63629-7780). Click a package code to view its specific billing and regulatory data.

63629-7780-1
30 TABLET in 1 BOTTLE

* 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 63629-7780-2 identifies a specific commercial package of 60 tablet in 1 bottle of Fludrocortisone Acetate, labeled by Bryant Ranch Prepack. 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 Bryant Ranch Prepack on February 14, 2003. The current certification is valid through December 30, 2022.

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 Bryant Ranch Prepack product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63629778002. 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 (5-4-1)
63629-7780-2
11-Digit CMS (5-4-2)
63629-7780-02

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