Xeljanz Solution
NDC Package 0069-1029-02

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

Package Information

Xeljanz (tofacitinib) solution 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 solution delivery system. Marketed by Pfizer Laboratories Div Pfizer Inc, this product is identified by NDC 0069-1029 and is authorized under FDA application NDA213082.

Identification & Billing

NDC Package Code
0069-1029-02
Package Description
1 BOTTLE in 1 CARTON / 240 mL in 1 BOTTLE (0069-1029-01)
Product Code
0069-1029
11-Digit Billing Format
00069102902
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Xeljanz
Non-Proprietary Name
Tofacitinib
Substance Name
Tofacitinib Citrate
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TOFACITINIB CITRATE 1 mg/mL
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 #
NDA213082
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-08-2021
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 0069-1029-02 identifies a specific commercial package of 1 bottle in 1 carton / 240 ml in 1 bottle (0069-1029-01) of Xeljanz, a human prescription drug labeled by Pfizer Laboratories Div Pfizer Inc. This solution 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 February 08, 2021. 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: 00069102902. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
0069-1029-02
11-Digit CMS (5-4-2)
00069-1029-02

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