Tofacitinib NDC 76282-816

NDC codes

FDA NDC Directory

Product NDC (as listed)76282-816Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76282-0816Add 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
76282-816-30	76282081630	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,Inc
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 219830
Marketing start: Jun 10, 2026
Listing expires: Dec 31, 2027
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

N476282081630 followed by a unit qualifier and the quantity

Package 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 May 1, 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. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 219830

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 219830
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