Prednisone Delayed Release Tablet, Delayed Release
NDC Package 43598-886-01

11-digit billing NDC: 43598088601 · Billing unit: EA · 100 EA per package
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Prednisone Delayed Release (prednisone) tablets is prednisone delayed-release tablets are indicated in the treatment of the following diseases or conditions:. This formulation utilizes a tablet, delayed release delivery system. Marketed by Dr. Reddys Laboratories Inc., this product is identified by NDC 43598-886 and is authorized under FDA application ANDA219477.

Identification & Billing

NDC Package Code
43598-886-01
Package Description
1 BOTTLE in 1 CARTON / 100 TABLET, DELAYED RELEASE in 1 BOTTLE
Product Code
43598-886
11-Digit Billing Format
43598088601
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Prednisone Delayed Release
Non-Proprietary Name
Prednisone
Substance Name
Prednisone
Dosage Form
Tablet, Delayed Release - A solid dosage form which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PREDNISONE 1 mg/1
Pharmacologic Class
Usage Information
Prednisone delayed-release tablets are indicated in the treatment of the following diseases or conditions:

Regulatory & Marketing

Labeler Name
Dr. Reddys Laboratories Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA219477
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-15-2025
Listing Expiration
12-31-2027
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 (43598-886). Click a package code to view its specific billing and regulatory data.

43598-886-30
1 BOTTLE in 1 CARTON / 30 TABLET, DELAYED RELEASE 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 43598-886-01 identifies a specific commercial package of 1 bottle in 1 carton / 100 tablet, delayed release in 1 bottle of Prednisone Delayed Release, a human prescription drug labeled by Dr. Reddys Laboratories Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package. This tablet, delayed release is formulated for oral use and contains prednisone 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 Dr. Reddys Laboratories Inc. on December 15, 2025. The current certification is valid through December 31, 2027.

How is this Dr. Reddys Laboratories Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43598088601. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. 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)
43598-886-01
11-Digit CMS (5-4-2)
43598-0886-01

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