Prescription drug · ANDA
Tofacitinib NDC 71085-099
Tofacitinib citrate 1 mg/mL · Solution · Oral · IPG Pharmaceuticals, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71085-099-24 | 71085009924 | 1 BOTTLE in 1 CARTON (71085-099-24) / 240 mL in 1 BOTTLEMarketed from Jun 15, 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 — 1 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- IPG Pharmaceuticals, Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219370
- Marketing start
- Listing expires
- Other FDA classes
- Janus Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 71085-099_56a8aa5c-a9a1-b977-e063-6294a90aa496SPL ID 56a8aa5c-a9a1-b977-e063-6294a90aa496SPL set ID cd1b61bf-de03-4198-89f6-f3952b79d2c2RxCUI 2478433UNII O1FF4DIV0DUPC 0371085099242
- 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
N471085009924followed by a unit qualifier and the quantityPackage 71085-0099-24. 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 oral solution is a Janus kinase (JAK) inhibitor. Tofacitinib oral solution is indicated for the treatment of pediatric patients 2 years of age and older with: Active psoriatic arthritis ( PsA), who have had an inadequate response or intolerance to one or more TNF blockers. Active polyarticular course juvenile idiopathic arthritis (pcJIA), who have had an inadequate response or intolerance to one or more TNF blockers. Limitations of Use : Use of tofacitinib oral solution for PsA or pcJIA in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine is not recommended. ( 1.2 , 1.4 ) 1.2 Psoriatic Arthritis Tofacitinib oral solution is indica…
Excerpt only. Read the full label for complete information.