Sorafenib Tablet, Film Coated
NDC Package 13668-682-60

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

Sorafenib tablets is •Sorafenib tablets are contraindicated in patients with known severe hypersensitivity to sorafenib or any other component of sorafenib tablets.•Sorafenib tablets in combination with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer [see Warnings and Precautions (5.8)]. This formulation utilizes a tablet, film coated delivery system. Marketed by Torrent Pharmaceuticals Limited, this product is identified by NDC 13668-682 and is authorized under FDA application ANDA217095.

Identification & Billing

NDC Package Code
13668-682-60
Package Description
60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
13668-682
11-Digit Billing Format
13668068260
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sorafenib
Non-Proprietary Name
Sorafenib
Substance Name
Sorafenib
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SORAFENIB 200 mg/1
Pharmacologic Class
Usage Information
•Sorafenib tablets are contraindicated in patients with known severe hypersensitivity to sorafenib or any other component of sorafenib tablets.•Sorafenib tablets in combination with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer [see Warnings and Precautions (5.8)].

Regulatory & Marketing

Labeler Name
Torrent Pharmaceuticals Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA217095
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-12-2023
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 (13668-682). Click a package code to view its specific billing and regulatory data.

13668-682-12
120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
13668-682-30
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
13668-682-74
10 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK

* 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 13668-682-60 identifies a specific commercial package of 60 tablet, film coated in 1 bottle, plastic of Sorafenib, a human prescription drug labeled by Torrent Pharmaceuticals Limited. This tablet, film coated is formulated for oral use and contains sorafenib 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 Torrent Pharmaceuticals Limited on April 12, 2023. The current certification is valid through December 31, 2027.

How is this Torrent Pharmaceuticals Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 13668068260. 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)
13668-682-60
11-Digit CMS (5-4-2)
13668-0682-60

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