Tofacitinib NDC 60505-6264

NDC codes

FDA NDC Directory

Product NDC (as listed)60505-6264Labeler and product segments. Claims need a package NDC.

Product NDC at billing width60505-6264Add 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
60505-6264-5	60505626405	500 TABLET, FILM COATED in 1 BOTTLE (60505-6264-5)Marketed from Jun 3, 2026
60505-6264-6	60505626406	60 TABLET, FILM COATED in 1 BOTTLE (60505-6264-6)Marketed from Jun 3, 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 — 10 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Apotex Corp.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218096
Marketing start: Jun 3, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Janus Kinase Inhibitors (Mechanism)
Identifiers: Product ID 60505-6264_a9726238-ded7-7fe2-a31c-dc1f492f19b1SPL ID a9726238-ded7-7fe2-a31c-dc1f492f19b1SPL set ID 7d4f5cfa-35a8-1458-a609-f6b417946abbRxCUI 1357541, 2048566UNII 87LA6FU830UPC 0360505626465, 0360505626366
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

N460505626405 followed by a unit qualifier and the quantity

Package 60505-6264-05. 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 4, 2026. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 218096

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

FDA NDC Directory listings under ANDA 218096
Product	Strength	Form · route	Labeler	Product NDC
Tofacitinib	Tofacitinib 5 mg/1	Tablet, Film coatedOral	Apotex Corp.	60505-6263
Tofacitinib	Tofacitinib 5 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	84677-054
Tofacitinib	Tofacitinib 10 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	84677-055