Tofacitinib Powder
NDC Package 71796-050-00

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Tofacitinib powders is tofacitinib is used to treat certain types of arthritis (such as psoriatic arthritis, rheumatoid arthritis, polyarticular course juvenile idiopathic arthritis-pcJIA). This formulation utilizes a powder delivery system. Marketed by Dr. Reddy's Laboratories Limited, this product is identified by NDC 71796-050.

Identification & Billing

NDC Package Code
71796-050-00
Package Description
1 kg in 1 DRUM
Product Code
71796-050
11-Digit Billing Format
71796005000

Clinical Specifications

Proprietary Name
Tofacitinib
Non-Proprietary Name
Tofacitinib
Substance Name
Tofacitinib Citrate
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
TOFACITINIB CITRATE 1 kg/kg
Usage Information
Tofacitinib is used to treat certain types of arthritis (such as psoriatic arthritis, rheumatoid arthritis, polyarticular course juvenile idiopathic arthritis-pcJIA). It helps to decrease pain/tenderness/swelling in the joints. Tofacitinib is also used to treat a certain bowel disease (ulcerative colitis). It helps to reduce symptoms of ulcerative colitis such as diarrhea, rectal bleeding, and stomach pain.

Regulatory & Marketing

Labeler Name
Dr. Reddy's Laboratories Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
07-29-2022
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 71796-050-00 identifies a specific commercial package of 1 kg in 1 drum of Tofacitinib (UNFINISHED drug), a bulk ingredient labeled by Dr. Reddy's Laboratories Limited. This powder is formulated for use and contains tofacitinib citrate 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 Limited on July 29, 2022. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Tofacitinib is used to treat certain types of arthritis (such as psoriatic arthritis, rheumatoid arthritis, polyarticular course juvenile idiopathic arthritis-pcJIA). It helps to decrease pain/tenderness/swelling in the joints. Tofacitinib is also used to treat a certain bowel disease (ulcerative colitis). It helps to reduce symptoms of ulcerative colitis such as diarrhea, rectal bleeding, and stomach pain.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71796005000. 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)
71796-050-00
11-Digit CMS (5-4-2)
71796-0050-00

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