Prescription drug · ANDA
Tofacitinib NDC 70069-842
Tofacitinib citrate 10 mg/1 · Tablet, Film coated · Oral · Somerset Therapeutics, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70069-842-01 | 70069084201 | 60 TABLET, FILM COATED in 1 BOTTLE (70069-842-01)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
- Somerset Therapeutics, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 220137
- Marketing start
- Listing expires
- Other FDA classes
- Janus Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 70069-842_ae14dcb9-cab8-46e0-88eb-530641074973SPL ID ae14dcb9-cab8-46e0-88eb-530641074973SPL set ID 2726c2b0-c763-4635-ac6b-4334c3a5a8bcRxCUI 1357541, 2048566UNII O1FF4DIV0DUPC 0370069842010, 0370069841013
- 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
N470069084201followed by a unit qualifier and the quantityPackage 70069-0842-01. 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 . 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 220137
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 5 mg/1 | Tablet, Film coatedOral | Somerset Therapeutics, LLC | 70069-841 |