Metformin Hydrochloride Extended Release Tablet, Extended Release
FDA Label NDC 68071-3111

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nucare Pharmaceuticals, Inc. for the product Metformin Hydrochloride Extended Release (NDC 68071-3111). 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 how supplied, metformin er tablets 500 mg, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

How Supplied

METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS ARE SUPPLIED:

bottles of 30 NDC 68071-3111-3

bottles of 60 NDC 68071-3111-6

bottles of 90 NDC 68071-3111-9

bottles of 120 NDC 68071-3111-2

bottles of 180 NDC 68071-3111-8

500 MG - White to Off-White capsule shaped no score imprint code 101

* Please review the disclaimer below.