Prescription drug · NDA
Xeljanz (Tofacitinib) NDC 0069-1002
Tofacitinib citrate 10 mg/1 · Tablet, Film coated · Oral · Pfizer Laboratories Div Pfizer Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0069-1002-01 | 0006910020100069100201 | 60 TABLET, FILM COATED in 1 BOTTLE (0069-1002-01)Marketed from Jul 2, 2018 |
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 — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Pfizer Laboratories Div Pfizer IncNDC labeler code 0069
- 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 0069-1002_23ff09f3-4af4-4232-a8b3-d84f8f16fb9cSPL ID 23ff09f3-4af4-4232-a8b3-d84f8f16fb9c
- 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
N400069100201followed by a unit qualifier and the quantityPackage 00069-1002-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 0069-1002
- What is NDC 0069-1002?
- 0069-1002 is the product NDC for Xeljanz (tofacitinib), Tofacitinib citrate 10 mg/1 tablet, film coated, listed with the FDA by Pfizer Laboratories Div Pfizer Inc. 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?
- Pfizer Laboratories Div Pfizer Inc, NDC labeler code 0069. 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 | U.S. Pharmaceuticals | 63539-016 | 63539-0016-02 |
| 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 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 |