Metformin Tablet, Extended Release
Product Images NDC 70518-4651

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Metformin (NDC 70518-4651). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Remedyrepack Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Mm1 (Metformin HCl 1000mg 70518 4651 00)

Label for Metformin HCl Extended-Release Tablet, 1000 mg strength, with quantity of 30 per box. The label includes warnings not to break, crush, or chew the tablets. It shows the NDC number 70518-4651-00 and states the product is repackaged by RemedyRepack Inc., Indiana, PA. Manufacturer details for Ingenus, Fairfield, NJ, are also present. The label advises storage at 20-25°C with permitted excursions to 15-30°C.*

FDA Label Image

Remedy_label (Remedy Label)

Metformin HCl Tablet Extended-Release 1000 mg, single tablet quantity label shows NDC 70518-4651-01. Label includes warnings against breaking, crushing, or chewing tablets and storage instructions. It is repackaged by RemedyRepack Inc., Indiana, PA.*

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Structure (Structure)

Chemical structure of the active ingredient metformin hydrochloride, shown as a 2D molecular diagram with atoms and bonds representing its chemical composition.*

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Table3 (Table 3)

A data table comparing pharmacokinetic parameters at 4 weeks for Metformin hydrochloride extended-release tablets 2,000 mg (administered once daily after dinner) versus Metformin HCl immediate-release tablets 2,000 mg (1,000 mg twice daily). Parameters shown include AUC, Tmax, and Cmax values with mean and standard deviation.*

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Table4 (Table 4)

A data table titled 'Select Mean (±S.D.) Metformin Pharmacokinetic Parameters Following Single or Multiple Oral Doses of Metformin HCl Tablets.' It presents pharmacokinetic parameters including peak plasma concentration (Cmax), time to peak plasma concentration (Tmax), and renal clearance (mL/min) for different subject groups and Metformin HCl doses, including healthy, nondiabetic adults, adults with type 2 diabetes mellitus, elderly healthy nondiabetic adults, and renal-impaired adults with varying degrees of renal function.*

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Table5 (Table 5)

Table showing the effect of coadministered drugs on plasma metformin systemic exposure (AUC and Cmax ratios). It lists various drugs, their doses, metformin dose, and geometric mean ratios comparing metformin exposure with and without each drug. Includes notes on dosing adjustments, renal tubular secretion, and metabolic acidosis risks.*

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Table6 (Table 6)

A data table titled 'Effect of Metformin on Coadministered Drug Systemic Exposure' showing the geometric mean ratios of area under the curve (AUC) and maximum concentration (Cmax) for various drugs coadministered with metformin. It lists drugs such as glyburide, furosemide, nifedipine, propranolol, ibuprofen, and cimetidine with their doses and corresponding metformin doses, indicating no dosing adjustments are required based on the reported ratios.*

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Table7 (Table 7)

A data table titled 'Mean Changes from Baseline in HbA1c and Fasting Plasma Glucose at Week 16 Comparing Metformin HCl Extended-Release Tablets vs Placebo in Patients with Type 2 Diabetes Mellitus.' It presents baseline values and change at final visit for Hemoglobin A1c and Fasting Plasma Glucose across different Metformin HCl extended-release tablet dosages (500 mg once daily to 1,000 mg twice daily) compared to placebo, including accompanying p-values.*

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Table8 (Table 8)

A data table titled 'Mean Changes from Baseline in HbA1c and Fasting Plasma Glucose at Week 24' comparing Metformin HCl Extended-Release 1000 mg and 1500 mg once daily to Metformin HCl 500 mg twice daily in patients with Type 2 Diabetes Mellitus. The table presents baseline values and changes at the final visit for Hemoglobin A1c (%) and Fasting Plasma Glucose (mg/dL) with sample sizes and 95% confidence intervals.*

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Table1 (Table1)

Table showing adverse reactions from clinical trials of Metformin HCl extended-release tablets versus placebo in type 2 diabetes patients. It lists diarrhea and nausea/vomiting with the percentage of patients experiencing each reaction in both groups.*

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Table2-1 (Table2 1)

A data table titled 'Clinically Significant Drug Interactions with metformin hydrochloride extended-release tablets.' It lists interactions with three categories: Carbonic Anhydrase Inhibitors, Drugs that Reduce Metformin hydrochloride extended-release tablets Clearance, and Alcohol. Each category includes clinical impact, intervention recommendations, and examples of relevant drugs.*

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Table2-2 (Table2 2)

A table titled 'Insulin Secretagogues or Insulin' and 'Drugs Affecting Glycemic Control' presenting clinical impact and intervention information related to coadministration and effects on glycemic control for patients taking metformin hydrochloride extended-release tablets. It includes examples of drugs that may affect glycemic control, such as thiazides, corticosteroids, and oral contraceptives.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.