Tofacitinib Tablet, Film Coated
FDA Label NDC 70771-1967

1 label section · Submitted to the FDA by Zydus Lifesciences Limited · 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 70771-1967). 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 Tablets, 5 mg

NDC 70771-1821-6

60 Tablets

Rx only

5 mg Label (C8e7d473 1e2e 4e6b B1b9 A9f2a8706665 01)

5 mg Label (C8e7d473 1e2e 4e6b B1b9 A9f2a8706665 01)

Tofacitinib Tablets, 10 mg

NDC 70771-1967-6

60 Tablets

Rx only

10 mg Label (C8e7d473 1e2e 4e6b B1b9 A9f2a8706665 02)

10 mg Label (C8e7d473 1e2e 4e6b B1b9 A9f2a8706665 02)

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