Prescription drug · ANDA
Tofacitinib NDC 76282-816
Tofacitinib citrate 11 mg/1 · Tablet, Film coated, Extended release · Oral · Exelan pharmaceuticals,Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76282-816-30 | 7628208163076282081630 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (76282-816-30)Marketed from Jun 10, 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 — 11 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Exelan pharmaceuticals,IncNDC labeler code 76282
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219830
- Marketing start
- Listing expires
- Other FDA classes
- Janus Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 76282-816_877be72f-0a5f-4eaa-8986-0b4af3e447a0SPL ID 877be72f-0a5f-4eaa-8986-0b4af3e447a0SPL set ID e68680e5-0328-4e66-b8bb-4af126221ec7RxCUI 1741046UNII O1FF4DIV0DUPC 0376282816302
- 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
N476282081630followed by a unit qualifier and the quantityPackage 76282-0816-30. 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 extended-release tablets are Janus kinase (JAK) inhibitors. Tofacitinib extended-release 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. L i mi t ation s o f Use: Use of tofacitinib extended-release tablets for RA, AS, or PsA in combination with biologic DMARDs or potent immunosuppressants such as azath…
Excerpt only. Read the full label for complete information.
About NDC 76282-816
- What is NDC 76282-816?
- 76282-816 is the product NDC for Tofacitinib, Tofacitinib citrate 11 mg/1 tablet, film coated, extended release, listed with the FDA by Exelan pharmaceuticals,Inc. It has 1 package NDC, 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?
- Exelan pharmaceuticals,Inc, NDC labeler code 76282. 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?
- 39 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 5 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc | 72865-366 | 72865-0366-1272865-0366-60 |
| Tofacitinib | Tofacitinib citrate 10 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc | 72865-367 | 72865-0367-1272865-0367-60 |
| Tofacitinib | Tofacitinib citrate 1 mg/mL | SolutionOral | Saptalis Pharmaceuticals, LLC. | 71656-071 | — |
| 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 | 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 |
Other NDCs under ANDA 219830
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 11 mg/1 | Tablet, Film coated, Extended releaseOral | Orient Pharma Co., Ltd. Yunlin Plant | 76333-111 |