Prescription drug · ANDA
Tofacitinib NDC 72205-140
Tofacitinib citrate 10 mg/1 · Tablet, Film coated · Oral · Novadoz Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72205-140-18 | 72205014018 | 180 TABLET, FILM COATED in 1 BOTTLE (72205-140-18)Marketed from Jun 3, 2026 | |
| 72205-140-28 | 72205014028 | 28 TABLET, FILM COATED in 1 BOTTLE (72205-140-28)Marketed from Jun 3, 2026 | |
| 72205-140-60 | 72205014060 | 60 TABLET, FILM COATED in 1 BOTTLE (72205-140-60)Marketed from Jun 3, 2026 |
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)
- Tofacitinib
- Generic name (nonproprietary)
- tofacitinib
- Active ingredients
- Tofacitinib citrate — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Novadoz Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217299
- Marketing start
- Listing expires
- Other FDA classes
- Janus Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 72205-140_25aada50-1f94-495f-9c11-8e2e9f282994SPL ID 25aada50-1f94-495f-9c11-8e2e9f282994SPL set ID 253635c8-1ea7-41ba-b216-dea5e3305c47RxCUI 1357541, 2048566UNII O1FF4DIV0DUPC 0372205139282, 0372205140288, 0372205139602, 0372205140189, 0372205140608
- 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
N472205014018followed by a unit qualifier and the quantityPackage 72205-0140-18. 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)
Tofacitinib tablets are Janus kinase (JAK) inhibitors. Tofacitinib tablets 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 blockers. Tofacitinib tablets are indicated for the treatment of pediatric pa…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 217299
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 |
|---|---|---|---|---|
| Tofacitinib | Tofacitinib citrate 10 mg/1 | Tablet, Film coatedOral | AvKARE | 73190-101 |
| Tofacitinib | Tofacitinib citrate 5 mg/1 | Tablet, Film coatedOral | AvKARE | 73190-100 |
| Tofacitinib | Tofacitinib citrate 5 mg/1 | Tablet, Film coatedOral | Novadoz Pharmaceuticals LLC | 72205-139 |