Metformin Hydrochloride Tablet, Extended Release
FDA Label NDC 65841-039

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 Metformin Hydrochloride (NDC 65841-039). 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

NDC 65841-027-05 in bottle of 500 tablets

Metformin Hydrochloride Extended-release Tablets USP, 500 mg

Rx only

500 tablets

500 mg (95f617f7 2d62 4c77 B0cc 1b2c3dcffcbd 01)

500 mg (95f617f7 2d62 4c77 B0cc 1b2c3dcffcbd 01)

NDC 65841-039-05 in bottle of 500 tablets

Metformin Hydrochloride Extended-release Tablets USP, 750 mg

Rx only

500 tablets

750 mg (95f617f7 2d62 4c77 B0cc 1b2c3dcffcbd 02)

750 mg (95f617f7 2d62 4c77 B0cc 1b2c3dcffcbd 02)

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