Tofacitinib Tablet, Film Coated
NDC Package 33342-541-54

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

Tofacitinib tablets 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 tablet, film coated delivery system. Marketed by Macleods Pharmaceuticals Limited, this product is identified by NDC 33342-541 and is authorized under FDA application ANDA219530.

Identification & Billing

NDC Package Code
33342-541-54
Package Description
120 TABLET, FILM COATED in 1 BOTTLE
Product Code
33342-541
11-Digit Billing Format
33342054154
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tofacitinib
Non-Proprietary Name
Tofacitinib
Substance Name
Tofacitinib Citrate
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)
TOFACITINIB CITRATE 5 mg/1
Pharmacologic Class
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
Macleods Pharmaceuticals Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA219530
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-03-2026
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 (33342-541). Click a package code to view its specific billing and regulatory data.

33342-541-09
60 TABLET, FILM COATED in 1 BOTTLE
33342-541-43
9 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK (33342-541-66)

* 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 33342-541-54 identifies a specific commercial package of 120 tablet, film coated in 1 bottle of Tofacitinib, a human prescription drug labeled by Macleods Pharmaceuticals Limited. This tablet, film coated is formulated for oral 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 Macleods Pharmaceuticals Limited on June 03, 2026. The current certification is valid through December 31, 2027.

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 Macleods Pharmaceuticals Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 33342054154. 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)
33342-541-54
11-Digit CMS (5-4-2)
33342-0541-54

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