Prescription drug · ANDA
Tofacitinib NDC 72865-366
Tofacitinib citrate 5 mg/1 · Tablet, Film coated · Oral · XLCare Pharmaceuticals Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72865-366-12 | 7286503661272865036612 | 120 TABLET, FILM COATED in 1 BOTTLE (72865-366-12)Marketed from Oct 9, 2026 | |
| 72865-366-60 | 7286503666072865036660 | 60 TABLET, FILM COATED in 1 BOTTLE (72865-366-60)Marketed from Oct 9, 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 — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- XLCare Pharmaceuticals IncNDC labeler code 72865
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219530
- Marketing start
- Listing expires
- Other FDA classes
- Janus Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 72865-366_10403307-e2f9-44d1-bc72-552fdba299d1SPL ID 10403307-e2f9-44d1-bc72-552fdba299d1
- 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
N472865036612followed by a unit qualifier and the quantityPackage 72865-0366-12. 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 72865-366
- What is NDC 72865-366?
- 72865-366 is the product NDC for Tofacitinib, Tofacitinib citrate 5 mg/1 tablet, film coated, listed with the FDA by XLCare Pharmaceuticals Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tofacitinib.
- What is the active ingredient?
- Tofacitinib citrate.
- Who is the labeler?
- XLCare Pharmaceuticals Inc, NDC labeler code 72865. 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?
- 38 other product NDCs are listed under this name. See all Tofacitinib NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tofacitinib 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 | Tofacitinib citrate 10 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc | 72865-367 | 72865-0367-1272865-0367-60 |
| Tofacitinib | Tofacitinib citrate 5 mg/1 | Tablet, Film coatedOral | AvKARE | 73190-100 | 73190-0100-60 |
| Tofacitinib | Tofacitinib citrate 10 mg/1 | Tablet, Film coatedOral | AvKARE | 73190-101 | 73190-0101-60 |
| Tofacitinib | Tofacitinib citrate 11 mg/1 | Tablet, Film coated, Extended releaseOral | AvKARE | 73190-102 | 73190-0102-30 |
| Tofacitinib | Tofacitinib citrate 1 mg/mL | SolutionOral | IPG Pharmaceuticals, Inc | 71085-099 | 71085-0099-24 |
| Tofacitinib | Tofacitinib citrate 11 mg/1 | Tablet, Film coated, Extended releaseOral | Exelan pharmaceuticals,Inc | 76282-816 | 76282-0816-30 |
| Tofacitinib | Tofacitinib citrate 11 mg/1 | Tablet, Film coated, Extended releaseOral | Orient Pharma Co., Ltd. Yunlin Plant | 76333-111 | 76333-0111-15 |
| Tofacitinib | Tofacitinib citrate 10 mg/1 | Tablet, Film coatedOral | Micro Labs Limited | 42571-377 | 42571-0377-0542571-0377-3042571-0377-60+1 more |
| tofacitinib | Tofacitinib citrate 10 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 70710-1589 | 70710-1589-0670710-1589-0770710-1589-08 |
| tofacitinib | Tofacitinib citrate 10 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1967 | 70771-1967-0670771-1967-0770771-1967-08 |
Other NDCs under ANDA 219530
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 | Macleods Pharmaceuticals Limited | 33342-541 |
| Tofacitinib | Tofacitinib citrate 10 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-542 |
| Tofacitinib | Tofacitinib citrate 10 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc | 72865-367 |