Dapagliflozin Tablet
FDA Label NDC 70771-1714

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 Dapagliflozin (NDC 70771-1714). 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

Dapagliflozin Tablets, 5 mg

NDC 70771-1714-3

Bottles of 30 tablets

Rx only

5 mg (E0ce1921 Cd6e 4663 Acd0 Ae34bd8222fa 01)

5 mg (E0ce1921 Cd6e 4663 Acd0 Ae34bd8222fa 01)

Dapagliflozin Tablets, 10 mg

NDC 70771-1715-3

Bottles of 30 tablets

Rx only

10 mg (E0ce1921 Cd6e 4663 Acd0 Ae34bd8222fa 02)

10 mg (E0ce1921 Cd6e 4663 Acd0 Ae34bd8222fa 02)

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