Xeljanz (tofacitinib) NDC 63539-016

NDC codes

FDA NDC Directory

Product NDC (as listed)63539-016Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63539-0016Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
63539-016-02	63539001602	60 TABLET, FILM COATED in 1 BOTTLE (63539-016-02)Marketed from Jul 2, 2018

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Xeljanz
Generic name (nonproprietary): tofacitinib
Active ingredients: Tofacitinib citrate — 10 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: U.S. Pharmaceuticals
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 203214
Marketing start: Jul 2, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Janus Kinase Inhibitors (Mechanism)
Identifiers: Product ID 63539-016_e8ed9fec-0cc3-403c-a731-72a6f8969afaSPL ID e8ed9fec-0cc3-403c-a731-72a6f8969afaSPL set ID 68e3d6b2-7838-4d2d-a417-09d919b43e13RxCUI 1357541, 1357547, 1741046, 1741049, 2048566, 2048568, 2273113, 2273115, 2478433, 2478437UNII O1FF4DIV0D
Pharmacologic class: Janus Kinase Inhibitor

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N463539001602 followed by a unit qualifier and the quantity

Package 63539-0016-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jul 13, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

XELJANZ (tablets and oral solution) and XELJANZ XR (extended-release tablets) are Janus kinase (JAK) inhibitors. XELJANZ tablets and XELJANZ XR are indicated for the treatment of adult patients with: • Moderately to severely active rheumatoid arthritis (RA), who have had an inadequate response or intolerance to one or more TNF blockers. • Active psoriatic arthritis (PsA), who have had an inadequate response or intolerance to one or more TNF blockers. • Active ankylosing spondylitis (AS), who have had an inadequate response or intolerance to one or more TNF blockers. • Moderately to severely active ulcerative colitis (UC), who have had an inadequate response or intolerance to one or more TNF …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 203214

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 203214
Product	Strength	Form · route	Labeler	Product NDC
Xeljanztofacitinib	Tofacitinib citrate 5 mg/1	Tablet, Film coatedOral	U.S. Pharmaceuticals	63539-012
Xeljanztofacitinib	Tofacitinib citrate 5 mg/1	Tablet, Film coatedOral	Pfizer Laboratories Div Pfizer Inc	0069-1001
Xeljanztofacitinib	Tofacitinib citrate 10 mg/1	Tablet, Film coatedOral	Pfizer Laboratories Div Pfizer Inc	0069-1002