Xeljanz (tofacitinib) NDC 0069-1001

NDC codes

FDA NDC Directory

Product NDC (as listed)0069-1001Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00069-1001Add 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
0069-1001-01	00069100101	60 TABLET, FILM COATED in 1 BOTTLE (0069-1001-01)Marketed from Nov 9, 2012

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Pfizer Laboratories Div Pfizer Inc
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 203214
Marketing start: Nov 9, 2012
Listing expires: Dec 31, 2027
Other FDA classes: Janus Kinase Inhibitors (Mechanism)
Identifiers: Product ID 0069-1001_40c4e5e1-3891-4949-bd0e-db319cc1e813SPL ID 40c4e5e1-3891-4949-bd0e-db319cc1e813SPL set ID cf74ba2f-afc5-4baa-8594-979c889a5831RxCUI 1357541, 1357547, 1741046, 1741049, 2048566, 2048568, 2273113, 2273115, 2478433, 2478437UNII O1FF4DIV0DUPC 0300691002018, 0300691001011
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

N400069100101 followed by a unit qualifier and the quantity

Package 00069-1001-01. 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 12, 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 10 mg/1	Tablet, Film coatedOral	U.S. Pharmaceuticals	63539-016
Xeljanztofacitinib	Tofacitinib citrate 10 mg/1	Tablet, Film coatedOral	Pfizer Laboratories Div Pfizer Inc	0069-1002