Tofacitinib NDC 33342-541

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-541Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0541Add 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
33342-541-09	33342054109	60 TABLET, FILM COATED in 1 BOTTLE (33342-541-09)Marketed from Jun 3, 2026
33342-541-43	33342054143	9 BLISTER PACK in 1 CARTON (33342-541-43) / 10 TABLET, FILM COATED in 1 BLISTER PACK (33342-541-66)Marketed from Jun 3, 2026
33342-541-54	33342054154	120 TABLET, FILM COATED in 1 BOTTLE (33342-541-54)Marketed from Jun 3, 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 — 5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Macleods Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 219530
Marketing start: Jun 3, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Janus Kinase Inhibitors (Mechanism)
Identifiers: Product ID 33342-541_65ea5dd6-afcb-4644-b4a2-1d407fc51f21SPL ID 65ea5dd6-afcb-4644-b4a2-1d407fc51f21SPL set ID 9b654f0d-7705-4880-9e9d-ad3a51e56b56RxCUI 1357541, 2048566UNII O1FF4DIV0DUPC 0333342541543, 0333342541437, 0333342542090, 0333342542540, 0333342542434, 0333342541093
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

N433342054109 followed by a unit qualifier and the quantity

Package 33342-0541-09. 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 6, 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 pe…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 219530

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

FDA NDC Directory listings under ANDA 219530
Product	Strength	Form · route	Labeler	Product NDC
Tofacitinib	Tofacitinib citrate 10 mg/1	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-542