What is NDC 42571-268?

42571-268 is the product NDC for Tofacitinib, Tofacitinib citrate 5 mg/1 tablet, film coated, listed with the FDA by Micro Labs Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.

Micro Labs Limited, NDC labeler code 42571. 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?

35 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 42571-268 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)42571-268Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42571-0268Add 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
42571-268-05	42571026805	500 TABLET, FILM COATED in 1 BOTTLE (42571-268-05)Marketed from Jun 3, 2026
42571-268-30	42571026830	30 TABLET, FILM COATED in 1 BOTTLE (42571-268-30)Marketed from Jun 3, 2026
42571-268-60	42571026860	60 TABLET, FILM COATED in 1 BOTTLE (42571-268-60)Marketed from Jun 3, 2026
42571-268-76	42571026876	150 BLISTER PACK in 1 CARTON (42571-268-76) / 15 TABLET, FILM COATED in 1 BLISTER PACK (42571-268-13)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: Micro Labs LimitedNDC labeler code 42571
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209738
Marketing start: Jun 3, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Janus Kinase Inhibitors (Mechanism)
Identifiers: Product ID 42571-268_5c4e0626-5f79-7e1f-e063-6294a90ad9cdSPL ID 5c4e0626-5f79-7e1f-e063-6294a90ad9cd
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

N442571026805 followed by a unit qualifier and the quantity

Package 42571-0268-05. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 42571-268

What is NDC 42571-268?: 42571-268 is the product NDC for Tofacitinib, Tofacitinib citrate 5 mg/1 tablet, film coated, listed with the FDA by Micro Labs Limited. It has 4 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?: Micro Labs Limited, NDC labeler code 42571. 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?: 35 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	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
tofacitinib	Tofacitinib citrate 10 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	70710-1589	70710-1589-0670710-1589-0770710-1589-08
tofacitinib	Tofacitinib citrate 10 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1967	70771-1967-0670771-1967-0770771-1967-08
Tofacitinib	Tofacitinib citrate 10 mg/1	Tablet, Film coatedOral	Somerset Therapeutics, LLC	70069-842	70069-0842-01

All 36 Tofacitinib NDCs

Other NDCs under ANDA 209738

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

FDA NDC Directory listings under ANDA 209738
Product	Strength	Form · route	Labeler	Product NDC
Tofacitinib	Tofacitinib citrate 10 mg/1	Tablet, Film coatedOral	Micro Labs Limited	42571-377