What is NDC 68254-5012?

68254-5012 is the product NDC for Tofacitinib Citrate, Tofacitinib citrate 16.16 mg/1 tablet, film coated, listed with the FDA by CONCORD BIOTECH LIMITED. It has 3 package NDCs, shown above in 10- and 11-digit form.

CONCORD BIOTECH LIMITED, NDC labeler code 68254. 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 68254-5012

NDC codes

FDA NDC Directory

Product NDC (as listed)68254-5012Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68254-5012Add 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
68254-5012-1	6825450120168254501201	28 TABLET, FILM COATED in 1 BOTTLE (68254-5012-1)Marketed from Oct 1, 2026
68254-5012-2	6825450120268254501202	60 TABLET, FILM COATED in 1 BOTTLE (68254-5012-2)Marketed from Oct 1, 2026
68254-5012-3	6825450120368254501203	180 TABLET, FILM COATED in 1 BOTTLE (68254-5012-3)Marketed from Oct 1, 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 Citrate
Generic name (nonproprietary): tofacitinib citrate
Active ingredients: Tofacitinib citrate — 16.16 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: CONCORD BIOTECH LIMITEDNDC labeler code 68254
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218821
Marketing start: Oct 1, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Janus Kinase Inhibitors (Mechanism)
Identifiers: Product ID 68254-5012_ad6e5467-da25-405d-a725-c95489d79aabSPL ID ad6e5467-da25-405d-a725-c95489d79aabSPL set ID 6c33e5b4-4843-4a80-a4f8-435bfceddc2aRxCUI 1357541, 2048566UNII 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

N468254501201 followed by a unit qualifier and the quantity

Package 68254-5012-01. 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 Oct 16, 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)

About NDC 68254-5012

What is NDC 68254-5012?: 68254-5012 is the product NDC for Tofacitinib Citrate, Tofacitinib citrate 16.16 mg/1 tablet, film coated, listed with the FDA by CONCORD BIOTECH LIMITED. It has 3 package NDCs, 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?: CONCORD BIOTECH LIMITED, NDC labeler code 68254. 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
Tofacitinib Citrate	Tofacitinib citrate 11 mg/1	Tablet, Film coated, Extended releaseOral	Padagis US LLC	0574-1811	00574-1811-30

Other NDCs under ANDA 218821

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

FDA NDC Directory listings under ANDA 218821
Product	Strength	Form · route	Labeler	Product NDC
Tofacitinib Citrate	Tofacitinib citrate 8.08 mg/1	Tablet, Film coatedOral	Stellon Biotech Inc.	85972-121
Tofacitinib Citrate	Tofacitinib citrate 16.16 mg/1	Tablet, Film coatedOral	Stellon Biotech Inc.	85972-122