Prescription drug · ANDA
Tofacitinib NDC 84677-055
Tofacitinib 10 mg/1 · Tablet, Film coated · Oral · Golden State Medical Supply, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84677-055-60 | 84677005560 | 60 TABLET, FILM COATED in 1 BOTTLE (84677-055-60)Marketed from Jun 1, 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 — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218096
- Marketing start
- Listing expires
- Other FDA classes
- Janus Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 84677-055_58f22511-eebf-fdbd-e063-6294a90adb8eSPL ID 58f22511-eebf-fdbd-e063-6294a90adb8eSPL set ID 58f22c41-87d2-e745-e063-6394a90a962eRxCUI 1357541, 2048566UNII 87LA6FU830
- 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
N484677005560followed by a unit qualifier and the quantityPackage 84677-0055-60. 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 218096
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 5 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-6263 |
| Tofacitinib | Tofacitinib 10 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-6264 |
| Tofacitinib | Tofacitinib 5 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 84677-054 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.