Prescription drug · ANDA
Tofacitinib (Tofacitinib citrate) NDC 51991-963
Tofacitinib citrate 10 mg/1 · Tablet · Oral · Breckenridge Pharmaceutical, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51991-963-06 | 5199109630651991096306 | 60 TABLET in 1 BOTTLE (51991-963-06)Marketed from Jun 3, 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 citrate
- Active ingredients
- Tofacitinib citrate — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Breckenridge Pharmaceutical, Inc.NDC labeler code 51991
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209633
- Marketing start
- Listing expires
- Other FDA classes
- Janus Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 51991-963_3e3b82fa-49eb-44e5-9489-1e7ea559e9ebSPL ID 3e3b82fa-49eb-44e5-9489-1e7ea559e9ebSPL set ID c963c610-52e5-43ab-aac6-3f7e5341b764RxCUI 1357541, 2048566UNII O1FF4DIV0D
- 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
N451991096306followed by a unit qualifier and the quantityPackage 51991-0963-06. 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 tablets are Janus kinase (JAK) inhibitors. Tofacitinib 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. Moderately to severely active ulcerative colitis (UC), who have had an inadequate response or intolerance to one or more TNF blockers. Tofacitinib tablets are indicated for the treatment of pediatric pa…
Excerpt only. Read the full label for complete information.
About NDC 51991-963
- What is NDC 51991-963?
- 51991-963 is the product NDC for Tofacitinib (tofacitinib citrate), Tofacitinib citrate 10 mg/1 tablet, listed with the FDA by Breckenridge Pharmaceutical, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tofacitinib (Tofacitinib Citrate).
- What is the active ingredient?
- Tofacitinib citrate.
- Who is the labeler?
- Breckenridge Pharmaceutical, Inc., NDC labeler code 51991. 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 | 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 |
Other NDCs under ANDA 209633
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 |
|---|---|---|---|---|
| Tofacitinibtofacitinib citrate | Tofacitinib citrate 5 mg/1 | TabletOral | Breckenridge Pharmaceutical, Inc. | 51991-329 |