Prescription drug · NDA
Xeljanz (Tofacitinib) NDC 63539-016
Tofacitinib citrate 10 mg/1 · Tablet, Film coated · Oral · U.S. Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63539-016-02 | 6353900160263539001602 | 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. PharmaceuticalsNDC labeler code 63539
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 203214
- Marketing start
- Listing expires
- 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
N463539001602followed by a unit qualifier and the quantityPackage 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 . 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.
About NDC 63539-016
- What is NDC 63539-016?
- 63539-016 is the product NDC for Xeljanz (tofacitinib), Tofacitinib citrate 10 mg/1 tablet, film coated, listed with the FDA by U.S. Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Xeljanz (Tofacitinib).
- What is the active ingredient?
- Tofacitinib citrate.
- Who is the labeler?
- U.S. Pharmaceuticals, NDC labeler code 63539. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Xeljanz?
- 5 other product NDCs are listed under this name. See all Xeljanz NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Xeljanz products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Xeljanztofacitinib | Tofacitinib citrate 1 mg/mL | SolutionOral | Pfizer Laboratories Div Pfizer Inc | 0069-1029 | 00069-1029-02 |
| Xeljanztofacitinib | Tofacitinib citrate 1 mg/mL | SolutionOral | U.S. Pharmaceuticals | 63539-029 | 63539-0029-02 |
| Xeljanztofacitinib | Tofacitinib citrate 10 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-1002 | 00069-1002-01 |
| Xeljanztofacitinib | Tofacitinib citrate 5 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-1001 | 00069-1001-01 |
| Xeljanztofacitinib | Tofacitinib citrate 5 mg/1 | Tablet, Film coatedOral | U.S. Pharmaceuticals | 63539-012 | 63539-0012-02 |
Other NDCs under NDA 203214
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| 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 |
| Xeljanztofacitinib | Tofacitinib citrate 5 mg/1 | Tablet, Film coatedOral | U.S. Pharmaceuticals | 63539-012 |