Tofacitinib Tablet, Film Coated, Extended Release
FDA Label NDC 70771-1627

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Zydus Lifesciences Limited for the product Tofacitinib (NDC 70771-1627). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Package Label.Principal Display Panel

Tofacitinib extended-release tablets, 11 mg

NDC 70771-1627-3

30 Tablets

Rx only

11 mg (7e9346bb C19d 43dc 90dd 6a99ad184add 01)

11 mg (7e9346bb C19d 43dc 90dd 6a99ad184add 01)

Tofacitinib extended-release tablets, 22 mg

NDC 70771-1628-3

30 Tablets

Rx only

22 mg (7e9346bb C19d 43dc 90dd 6a99ad184add 02)

22 mg (7e9346bb C19d 43dc 90dd 6a99ad184add 02)

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