Metformin Hydrochloride Tablet, Extended Release
FDA Label NDC 65841-027

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 Metformin Hydrochloride (NDC 65841-027). 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 65841-027-10 in bottle of 1000 tablets

Metformin Hydrochloride Extended-release Tablets USP, 500 mg

Rx only

1000 tablets

500 mg (D6499cd6 Fa2b 4c97 8f96 37ac878f0bac 01)

500 mg (D6499cd6 Fa2b 4c97 8f96 37ac878f0bac 01)

NDC 65841-039-01 in bottle of 100 tablets

Metformin Hydrochloride Extended-release Tablets USP, 750 mg

Rx only

100 tablets

750 mg (D6499cd6 Fa2b 4c97 8f96 37ac878f0bac 02)

750 mg (D6499cd6 Fa2b 4c97 8f96 37ac878f0bac 02)

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