Fludrocortisone Acetate Tablet
NDC Package 69238-7033-5

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

Fludrocortisone Acetate tablets is fludrocortisone is a man-made form of a natural substance (glucocorticoid) made by the body. This formulation utilizes a tablet delivery system. Marketed by Amneal Pharmaceuticals Ny Llc, this product is identified by NDC 69238-7033 and is authorized under FDA application ANDA040431.

Identification & Billing

NDC Package Code
69238-7033-5
Package Description
500 TABLET in 1 BOTTLE
Product Code
69238-7033
11-Digit Billing Format
69238703305
RxNorm Crosswalk
RxCUI: 313979 - fludrocortisone acetate 0.1 MG Oral Tablet

Clinical Specifications

Proprietary Name
Fludrocortisone Acetate
Non-Proprietary Name
Fludrocortisone Acetate
Substance Name
Fludrocortisone Acetate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
FLUDROCORTISONE ACETATE .1 mg/1
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
Amneal Pharmaceuticals Ny Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA040431
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-18-2002
Listing Expiration
12-31-2026
Exclude Flag
N
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 (69238-7033). Click a package code to view its specific billing and regulatory data.

69238-7033-1
100 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 69238-7033-5 identifies a specific commercial package of 500 tablet in 1 bottle of Fludrocortisone Acetate, a human prescription drug labeled by Amneal Pharmaceuticals Ny Llc. This tablet is formulated for oral use and contains fludrocortisone acetate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Amneal Pharmaceuticals Ny Llc on March 18, 2002. The current certification is valid through December 31, 2026.

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 Amneal Pharmaceuticals Ny Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69238703305. 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)
69238-7033-5
11-Digit CMS (5-4-2)
69238-7033-05

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