What is NDC 59651-459?

59651-459 is the product NDC for Tofacitinib, Tofacitinib citrate 5 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Aurobindo Pharma Limited, NDC labeler code 59651. 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 59651-459 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)59651-459Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59651-0459Add 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
59651-459-60	5965104596059651045960	60 TABLET, FILM COATED in 1 BOTTLE (59651-459-60)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: Aurobindo Pharma LimitedNDC labeler code 59651
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215356
Marketing start: Jun 3, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Janus Kinase Inhibitors (Mechanism)
Identifiers: Product ID 59651-459_d16d4aab-d9ca-45a7-a858-f7d5f254109cSPL ID d16d4aab-d9ca-45a7-a858-f7d5f254109cSPL set ID 50962b08-99dd-ae73-e063-6394a90ad1ebRxCUI 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

N459651045960 followed by a unit qualifier and the quantity

Package 59651-0459-60. 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 17, 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 59651-459

What is NDC 59651-459?: 59651-459 is the product NDC for Tofacitinib, Tofacitinib citrate 5 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, 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?: Aurobindo Pharma Limited, NDC labeler code 59651. 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 215356

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

FDA NDC Directory listings under ANDA 215356
Product	Strength	Form · route	Labeler	Product NDC
Tofacitinib	Tofacitinib citrate 10 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	59651-460