Lenalidomide Capsule
NDC Package 43598-511-63

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

Lenalidomide capsules is lenalidomide is used to treat various types of cancers. This formulation utilizes a capsule delivery system. Marketed by Dr. Reddy's Laboratories Inc., this product is identified by NDC 43598-511 and is authorized under FDA application ANDA209348.

Identification & Billing

NDC Package Code
43598-511-63
Package Description
28 CAPSULE in 1 BOTTLE
Product Code
43598-511
11-Digit Billing Format
43598051163
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
28 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lenalidomide
Non-Proprietary Name
Lenalidomide
Substance Name
Lenalidomide
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LENALIDOMIDE 5 mg/1
Pharmacologic Class
Thalidomide Analog - [EPC] (Established Pharmacologic Class)
Usage Information
Lenalidomide is used to treat various types of cancers. It works by slowing or stopping the growth of cancer cells. It is also used to treat anemia in patients with certain blood/bone marrow disorders (myelodysplastic syndromes-MDS). Lenalidomide may lessen the need for blood transfusions. Lenalidomide is not recommended for the treatment of a certain type of cancer (chronic lymphocytic leukemia) because of the increased risk of serious heart-related side effects and death. If you have this type of cancer, talk to your doctor about the risks of using this medication.

Regulatory & Marketing

Labeler Name
Dr. Reddy's Laboratories Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA209348
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-07-2022
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 (43598-511). Click a package code to view its specific billing and regulatory data.

43598-511-01
100 CAPSULE 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 43598-511-63 identifies a specific commercial package of 28 capsule in 1 bottle of Lenalidomide, a human prescription drug labeled by Dr. Reddy's Laboratories Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 28 billable units per package. This capsule is formulated for oral use and contains lenalidomide 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. Reddy's Laboratories Inc. on September 07, 2022. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Lenalidomide is used to treat various types of cancers. It works by slowing or stopping the growth of cancer cells. It is also used to treat anemia in patients with certain blood/bone marrow disorders (myelodysplastic syndromes-MDS). Lenalidomide may lessen the need for blood transfusions. Lenalidomide is not recommended for the treatment of a certain type of cancer (chronic lymphocytic leukemia) because of the increased risk of serious heart-related side effects and death. If you have this type of cancer, talk to your doctor about the risks of using this medication.

How is this Dr. Reddy's Laboratories Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43598051163. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 28 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)
43598-511-63
11-Digit CMS (5-4-2)
43598-0511-63

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