Prescription drug · ANDA
Tofacitinib Citrate NDC 77771-567
Tofacitinib citrate 11 mg/1 · Tablet, Film coated, Extended release · Oral · Radha Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 77771-567-30 | 7777105673077771056730 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (77771-567-30)Marketed from Jul 14, 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 — 11 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Radha Pharmaceuticals, Inc.NDC labeler code 77771
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 220972
- Marketing start
- Listing expires
- Other FDA classes
- Janus Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 77771-567_12039792-2d83-46ac-be82-fdbd00191024SPL ID 12039792-2d83-46ac-be82-fdbd00191024SPL set ID 141ab3eb-982b-4242-89db-6ddce5be0c40RxCUI 1741046UNII O1FF4DIV0DUPC 0377771567309
- 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
N477771056730followed by a unit qualifier and the quantityPackage 77771-0567-30. 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. Moderately to severely active ulcerative colitis (UC), who have had an inadequate response or intolerance to one or more TNF blockers. Limitations of Use: Use of tofaci…
Excerpt only. Read the full label for complete information.
About NDC 77771-567
- What is NDC 77771-567?
- 77771-567 is the product NDC for Tofacitinib Citrate, Tofacitinib citrate 11 mg/1 tablet, film coated, extended release, listed with the FDA by Radha Pharmaceuticals, 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?
- Radha Pharmaceuticals, Inc., NDC labeler code 77771. 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 8.08 mg/1 | Tablet, Film coatedOral | Stellon Biotech Inc. | 85972-121 | 85972-0121-60 |
| 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 | Padagis US LLC | 0574-1811 | 00574-1811-30 |
Other NDCs under ANDA 220972
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 11 mg/1 | Tablet, Film coated, Extended releaseOral | ScieGen Pharmaceuticals, INC. | 50228-567 |