Prescription drug · ANDA
Tofacitinib Citrate NDC 85972-121
Tofacitinib citrate 8.08 mg/1 · Tablet, Film coated · Oral · Stellon Biotech Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85972-121-60 | 85972012160 | 60 TABLET, FILM COATED in 1 BOTTLE (85972-121-60)Marketed from Oct 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 Citrate
- Generic name (nonproprietary)
- tofacitinib citrate
- Active ingredients
- Tofacitinib citrate — 8.08 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Stellon Biotech Inc.NDC labeler code 85972
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218821
- Marketing start
- Listing expires
- Other FDA classes
- Janus Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 85972-121_9d643ba7-2cb4-495a-b96d-3c1f2832442fSPL ID 9d643ba7-2cb4-495a-b96d-3c1f2832442f
- 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
N485972012160followed by a unit qualifier and the quantityPackage 85972-0121-60. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 85972-121
- What is NDC 85972-121?
- 85972-121 is the product NDC for Tofacitinib Citrate, Tofacitinib citrate 8.08 mg/1 tablet, film coated, listed with the FDA by Stellon Biotech Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tofacitinib Citrate.
- What is the active ingredient?
- Tofacitinib citrate.
- Who is the labeler?
- Stellon Biotech Inc., NDC labeler code 85972. 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 Citrate?
- 4 other product NDCs are listed under this name. See all Tofacitinib Citrate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tofacitinib Citrate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tofacitinib Citrate | Tofacitinib citrate 16.16 mg/1 | Tablet, Film coatedOral | Stellon Biotech Inc. | 85972-122 | 85972-0122-60 |
| Tofacitinib Citrate | Tofacitinib citrate 11 mg/1 | Tablet, Film coated, Extended releaseOral | ScieGen Pharmaceuticals, INC. | 50228-567 | 50228-0567-1050228-0567-30 |
| Tofacitinib Citrate | Tofacitinib citrate 11 mg/1 | Tablet, Film coated, Extended releaseOral | Radha Pharmaceuticals, Inc. | 77771-567 | 77771-0567-30 |
| Tofacitinib Citrate | Tofacitinib citrate 11 mg/1 | Tablet, Film coated, Extended releaseOral | Padagis US LLC | 0574-1811 | 00574-1811-30 |
Other NDCs under ANDA 218821
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 Citrate | Tofacitinib citrate 16.16 mg/1 | Tablet, Film coatedOral | Stellon Biotech Inc. | 85972-122 |