Tofacitinib NDC 60505-4858

NDC codes

FDA NDC Directory

Product NDC (as listed)60505-4858Labeler and product segments. Claims need a package NDC.

Product NDC at billing width60505-4858Add 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
60505-4858-3	60505485803	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-4858-3)Marketed from Jun 9, 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: Apotex Corp.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 220458
Marketing start: Jun 3, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Janus Kinase Inhibitors (Mechanism)
Identifiers: Product ID 60505-4858_87f0138c-b800-16f1-2666-292007be6353SPL ID 87f0138c-b800-16f1-2666-292007be6353SPL set ID dd62a2b8-300b-d92b-7b27-a30eaa68fdd3RxCUI 1741046UNII 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

N460505485803 followed by a unit qualifier and the quantity

Package 60505-4858-03. 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 Jul 27, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Tofacitinib extended-release tablets are a 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 tofa…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 220458

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

FDA NDC Directory listings under ANDA 220458
Product	Strength	Form · route	Labeler	Product NDC
Tofacitinib	Tofacitinib citrate 11 mg/1	Tablet, Film coated, Extended releaseOral	AvKARE	73190-102