What is NDC 0574-1811?

0574-1811 is the product NDC for Tofacitinib Citrate, Tofacitinib citrate 11 mg/1 tablet, film coated, extended release, listed with the FDA by Padagis US LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Padagis US LLC, NDC labeler code 0574. 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 Citrate?

4 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tofacitinib Citrate NDC 0574-1811 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0574-1811Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00574-1811Add 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
0574-1811-30	0057418113000574181130	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0574-1811-30)Marketed from Jun 15, 2026

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 Citrate
Generic name (nonproprietary): tofacitinib citrate
Active ingredients: Tofacitinib citrate — 11 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Padagis US LLCNDC labeler code 0574
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216001
Marketing start: Jun 15, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Janus Kinase Inhibitors (Mechanism)
Identifiers: Product ID 0574-1811_eedc8eff-2b96-4d74-837a-3093446a5d06SPL ID eedc8eff-2b96-4d74-837a-3093446a5d06SPL set ID df24e90d-4b2c-4f9d-a1d6-fcb1ab00606fRxCUI 1741046UNII O1FF4DIV0DUPC 0305741811305
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

N400574181130 followed by a unit qualifier and the quantity

Package 00574-1811-30. 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 Apr 30, 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. Limitations of Use : • Use of tofacitinib extended-release tablets for RA, AS, or PsA in combination with biologic DMARDs or potent immunosuppressants such as aza…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0574-1811

What is NDC 0574-1811?: 0574-1811 is the product NDC for Tofacitinib Citrate, Tofacitinib citrate 11 mg/1 tablet, film coated, extended release, listed with the FDA by Padagis US LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Tofacitinib Citrate.
What is the active ingredient?: Tofacitinib citrate.
Who is the labeler?: Padagis US LLC, NDC labeler code 0574. 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 Citrate?: 4 other product NDCs are listed under this name. See all Tofacitinib Citrate 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 Citrate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Tofacitinib Citrate	Tofacitinib citrate 8.08 mg/1	Tablet, Film coatedOral	Stellon Biotech Inc.	85972-121	85972-0121-60
Tofacitinib Citrate	Tofacitinib citrate 16.16 mg/1	Tablet, Film coatedOral	Stellon Biotech Inc.	85972-122	85972-0122-60
Tofacitinib Citrate	Tofacitinib citrate 11 mg/1	Tablet, Film coated, Extended releaseOral	ScieGen Pharmaceuticals, INC.	50228-567	50228-0567-1050228-0567-30
Tofacitinib Citrate	Tofacitinib citrate 11 mg/1	Tablet, Film coated, Extended releaseOral	Radha Pharmaceuticals, Inc.	77771-567	77771-0567-30