What is NDC 70771-1628?

70771-1628 is the product NDC for tofacitinib, Tofacitinib citrate 22 mg/1 tablet, film coated, extended release, listed with the FDA by Zydus Lifesciences Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Zydus Lifesciences Limited, NDC labeler code 70771. 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 70771-1628 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70771-1628Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70771-1628Add 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
70771-1628-3	7077116280370771162803	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1628-3)Marketed from May 20, 2026
70771-1628-9	7077116280970771162809	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1628-9)Marketed from May 20, 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
Generic name (nonproprietary): tofacitinib
Active ingredients: Tofacitinib citrate — 22 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Zydus Lifesciences LimitedNDC labeler code 70771
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214264
Marketing start: May 20, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Janus Kinase Inhibitors (Mechanism)
Identifiers: Product ID 70771-1628_8997ddda-2a43-45c8-98b0-f1ac03fa3d09SPL ID 8997ddda-2a43-45c8-98b0-f1ac03fa3d09SPL set ID ac0b26d5-1352-42ff-b5ea-3eb02d8508a4RxCUI 1741046, 2273113UNII O1FF4DIV0DUPC 0370710172732, 0370710135331
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

N470771162803 followed by a unit qualifier and the quantity

Package 70771-1628-03. 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 May 12, 2026.

Full label on DailyMed (opens in a new tab)

About NDC 70771-1628

What is NDC 70771-1628?: 70771-1628 is the product NDC for tofacitinib, Tofacitinib citrate 22 mg/1 tablet, film coated, extended release, listed with the FDA by Zydus Lifesciences Limited. It has 2 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?: Zydus Lifesciences Limited, NDC labeler code 70771. 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 214264

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

FDA NDC Directory listings under ANDA 214264
Product	Strength	Form · route	Labeler	Product NDC
tofacitinib	Tofacitinib citrate 11 mg/1	Tablet, Film coated, Extended releaseOral	Zydus Pharmaceuticals USA Inc.	70710-1353
tofacitinib	Tofacitinib citrate 22 mg/1	Tablet, Film coated, Extended releaseOral	Zydus Pharmaceuticals USA Inc.	70710-1727
tofacitinib	Tofacitinib citrate 11 mg/1	Tablet, Film coated, Extended releaseOral	Zydus Lifesciences Limited	70771-1627