Prescription drug · ANDA
tofacitinib NDC 70710-1243
Tofacitinib citrate 5 mg/1 · Tablet, Film coated · Oral · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70710-1243-6 | 70710124306 | 60 TABLET, FILM COATED in 1 BOTTLE (70710-1243-6)Marketed from May 11, 2026 | |
| 70710-1243-8 | 70710124308 | 180 TABLET, FILM COATED in 1 BOTTLE (70710-1243-8)Marketed from May 11, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209829
- Marketing start
- Listing expires
- Other FDA classes
- Janus Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 70710-1243_1587462d-cea8-47f1-b679-504d4b460c3dSPL ID 1587462d-cea8-47f1-b679-504d4b460c3dSPL set ID 21a89264-8047-40ac-8b10-fa6461072509RxCUI 1357541, 2048566UNII 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
N470710124306followed by a unit qualifier and the quantityPackage 70710-1243-06. 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 209829
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 | Zydus Lifesciences Limited | 70771-1967 |
| tofacitinib | Tofacitinib citrate 5 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1821 |
| tofacitinib | Tofacitinib citrate 10 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 70710-1589 |
- openFDA data updated
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