Sunitinib Malate Capsule
NDC Package 43598-045-28

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

Sunitinib Malate capsules is a medication used to treat certain types of cancer (kidney, pancreas, and intestinal). This formulation utilizes a capsule delivery system. Marketed by Dr.reddys Laboratories Inc, this product is identified by NDC 43598-045 and is authorized under FDA application ANDA215843.

Identification & Billing

NDC Package Code
43598-045-28
Package Description
4 BLISTER PACK in 1 CARTON / 7 CAPSULE in 1 BLISTER PACK (43598-045-70)
Product Code
43598-045
11-Digit Billing Format
43598004528
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sunitinib Malate
Non-Proprietary Name
Sunitinib Malate
Substance Name
Sunitinib Malate
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)
SUNITINIB MALATE 12.5 mg/1
Pharmacologic Class
Usage Information
This medication is used to treat certain types of cancer (kidney, pancreas, and intestinal). It is also used to treat people who are at high risk of the kidney cancer coming back again after having kidney surgery. Sunitinib works by stopping or slowing the growth of cancer tumors. It also works by slowing the growth of new blood vessels within the tumor.

Regulatory & Marketing

Labeler Name
Dr.reddys Laboratories Inc
Product Type
Human Prescription Drug
FDA Application #
ANDA215843
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-30-2022
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 (43598-045). Click a package code to view its specific billing and regulatory data.

43598-045-63
28 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 43598-045-28 identifies a specific commercial package of 4 blister pack in 1 carton / 7 capsule in 1 blister pack (43598-045-70) of Sunitinib Malate, a human prescription drug labeled by Dr.reddys Laboratories Inc. This capsule is formulated for oral use and contains sunitinib malate 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 November 30, 2022. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat certain types of cancer (kidney, pancreas, and intestinal). It is also used to treat people who are at high risk of the kidney cancer coming back again after having kidney surgery. Sunitinib works by stopping or slowing the growth of cancer tumors. It also works by slowing the growth of new blood vessels within the tumor.

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: 43598004528. 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)
43598-045-28
11-Digit CMS (5-4-2)
43598-0045-28

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