Prescription drug · ANDA
tofacitinib solution (Tofacitinib) NDC 0054-0821
Tofacitinib citrate 1 mg/mL · Solution · Oral · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0054-0821-58 | 0005408215800054082158 | 1 BOTTLE in 1 CARTON (0054-0821-58) / 240 mL in 1 BOTTLEMarketed from Jun 3, 2026 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 solution
- Generic name (nonproprietary)
- tofacitinib
- Active ingredients
- Tofacitinib citrate — 1 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Hikma Pharmaceuticals USA Inc.NDC labeler code 0054
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216878
- Marketing start
- Listing expires
- Other FDA classes
- Janus Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 0054-0821_b5f66dbf-b020-442e-bf19-4af33ac3c802SPL ID b5f66dbf-b020-442e-bf19-4af33ac3c802SPL set ID d9cf18a9-e825-49ac-b080-68957c0e79aeRxCUI 2478433UNII O1FF4DIV0DUPC 0300540821586
- 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
N400054082158followed by a unit qualifier and the quantityPackage 00054-0821-58. 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 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 indicated for th…
Excerpt only. Read the full label for complete information.
About NDC 0054-0821
- What is NDC 0054-0821?
- 0054-0821 is the product NDC for tofacitinib solution (tofacitinib), Tofacitinib citrate 1 mg/mL solution, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- tofacitinib solution (Tofacitinib).
- What is the active ingredient?
- Tofacitinib citrate.
- Who is the labeler?
- Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for tofacitinib solution?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.