tofacitinib NDC 70771-1628

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	70771162803	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1628-3)Marketed from May 20, 2026
70771-1628-9	70771162809	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 Limited
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)

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 Lifesciences Limited	70771-1627
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