tofacitinib NDC 70710-1353

NDC codes

FDA NDC Directory

Product NDC (as listed)70710-1353Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70710-1353Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
70710-1353-3	70710135303	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70710-1353-3)Marketed from May 20, 2026
70710-1353-9	70710135309	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70710-1353-9)Marketed from May 20, 2026

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: Zydus Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214264
Marketing start: May 20, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Janus Kinase Inhibitors (Mechanism)
Identifiers: Product ID 70710-1353_e36ed3d6-ca72-49fe-beb1-3506a7e53990SPL ID e36ed3d6-ca72-49fe-beb1-3506a7e53990SPL set ID 179ffbb2-bedc-40e6-b77b-33d4f7832172RxCUI 1741046, 2273113UNII O1FF4DIV0DUPC 0370710135331, 0370710172732
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

N470710135303 followed by a unit qualifier and the quantity

Package 70710-1353-03. 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 Aug 7, 2026. 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.

Full label on DailyMed (opens in a new tab)