Xeljanz Tablet, Film Coated, Extended Release
NDC Package 0069-0502-30

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

Package Information

Xeljanz (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, extended release delivery system. Marketed by Pfizer Laboratories Div Pfizer Inc, this product is identified by NDC 0069-0502 and is authorized under FDA application NDA208246.

Identification & Billing

NDC Package Code
0069-0502-30
Package Description
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code
0069-0502
11-Digit Billing Format
00069050230
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Xeljanz XR
Non-Proprietary Name
Tofacitinib
Substance Name
Tofacitinib Citrate
Dosage Form
Tablet, Film Coated, Extended Release - 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; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TOFACITINIB CITRATE 22 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
Pfizer Laboratories Div Pfizer Inc
Product Type
Human Prescription Drug
FDA Application #
NDA208246
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-21-2020
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0069-0502-30 identifies a specific commercial package of 30 tablet, film coated, extended release in 1 bottle of Xeljanz XR, a human prescription drug labeled by Pfizer Laboratories Div Pfizer Inc. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This tablet, film coated, extended release 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 Pfizer Laboratories Div Pfizer Inc on January 21, 2020. 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 Pfizer Laboratories Div Pfizer Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00069050230. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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 (4-4-2)
0069-0502-30
11-Digit CMS (5-4-2)
00069-0502-30

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