What is NDC 33342-541?

33342-541 is the product NDC for Tofacitinib, Tofacitinib citrate 5 mg/1 tablet, film coated, listed with the FDA by Macleods Pharmaceuticals Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.

Macleods Pharmaceuticals Limited, NDC labeler code 33342. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Tofacitinib?

39 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tofacitinib NDC 33342-541 | National Drug Code

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	3334205410933342054109	60 TABLET, FILM COATED in 1 BOTTLE (33342-541-09)Marketed from Jun 3, 2026
33342-541-43	3334205414333342054143	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	3334205415433342054154	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 LimitedNDC labeler code 33342
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)

About NDC 33342-541

What is NDC 33342-541?: 33342-541 is the product NDC for Tofacitinib, Tofacitinib citrate 5 mg/1 tablet, film coated, listed with the FDA by Macleods Pharmaceuticals Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Tofacitinib.
What is the active ingredient?: Tofacitinib citrate.
Who is the labeler?: Macleods Pharmaceuticals Limited, NDC labeler code 33342. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tofacitinib?: 39 other product NDCs are listed under this name. See all Tofacitinib NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Tofacitinib NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Tofacitinib	Tofacitinib citrate 5 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals Inc	72865-366	72865-0366-1272865-0366-60
Tofacitinib	Tofacitinib citrate 10 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals Inc	72865-367	72865-0367-1272865-0367-60
Tofacitinib	Tofacitinib citrate 1 mg/mL	SolutionOral	Saptalis Pharmaceuticals, LLC.	71656-071	—
Tofacitinib	Tofacitinib citrate 5 mg/1	Tablet, Film coatedOral	AvKARE	73190-100	73190-0100-60
Tofacitinib	Tofacitinib citrate 10 mg/1	Tablet, Film coatedOral	AvKARE	73190-101	73190-0101-60
Tofacitinib	Tofacitinib citrate 11 mg/1	Tablet, Film coated, Extended releaseOral	AvKARE	73190-102	73190-0102-30
Tofacitinib	Tofacitinib citrate 1 mg/mL	SolutionOral	IPG Pharmaceuticals, Inc	71085-099	71085-0099-24
Tofacitinib	Tofacitinib citrate 11 mg/1	Tablet, Film coated, Extended releaseOral	Exelan pharmaceuticals,Inc	76282-816	76282-0816-30
Tofacitinib	Tofacitinib citrate 11 mg/1	Tablet, Film coated, Extended releaseOral	Orient Pharma Co., Ltd. Yunlin Plant	76333-111	76333-0111-15
Tofacitinib	Tofacitinib citrate 10 mg/1	Tablet, Film coatedOral	Micro Labs Limited	42571-377	42571-0377-0542571-0377-3042571-0377-60+1 more

All 40 Tofacitinib NDCs

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
Tofacitinib	Tofacitinib citrate 5 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals Inc	72865-366
Tofacitinib	Tofacitinib citrate 10 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals Inc	72865-367