Metformin Hydrochloride Tablet
Product Images NDC 68645-582

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Metformin Hydrochloride (NDC 68645-582). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Legacy Pharmaceutical Packaging, Llc, 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

Metformin 1000mg

Metformin Hydrochloride Tablets, USP 1000 mg oral tablets in a white rectangular label. The label shows the product name and strength prominently in blue and black text. It states the package contains 60 tablets. The label includes usage information, storage instructions, and a caution to keep out of reach of children. The NDC number 68645-584-59 and distributor details are listed. The labeler is Legacy Pharmaceutical Packaging LLC, Earth City, MO.*

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Metformin 500mg

Metformin Hydrochloride Tablets, USP 500 mg oral tablets label by Legacy Pharmaceutical Packaging, LLC. The label indicates 60 tablets with NDC 68645-582-59. It includes directions for use, storage instructions, and warnings. Distributed by Wal-Mart and manufactured by Granules India Limited, made in India.*

FDA Label Image

Metformin 850mg

Metformin Hydrochloride Tablets, USP 850 mg oral tablet label from Legacy Pharmaceutical Packaging, LLC. The label indicates 60 tablets per container, with directions for pharmacist dispensing, dosage information, and storage instructions. The manufacturer is Granules India Limited, and the product is distributed by Wal-Mart in Bentonville, Arkansas.*

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Table 1 (Metformin Granules 1)

A data table comparing the incidence of various side effects between Metformin Hydrochloride Tablets (n=141) and Placebo (n=145). Side effects listed include diarrhea, nausea/vomiting, flatulence, asthenia, indigestion, abdominal discomfort, and headache, with percentage values for each group.*

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Table 11 (Metformin Granules 10)

A data table comparing clinical results for Metformin Hydrochloride Tablets 500 mg taken twice daily with Metformin Hydrochloride Extended-Release Tablets 1000 mg and 1500 mg taken once daily. The table includes sample sizes (n), Hemoglobin A1c percentage baselines and changes at the final visit with 95% confidence intervals, and fasting plasma glucose (FPG) levels in mg/dL at baseline and final visit changes with 95% confidence intervals.*

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Table 3 (Metformin Granules 2)

A text panel listing clinical impacts, interventions, and examples related to interactions with metformin hydrochloride tablets. It covers carbonic anhydrase inhibitors, drugs reducing metformin clearance, alcohol, insulin secretagogues or insulin, and drugs affecting glycemic control, highlighting effects on serum bicarbonate, renal elimination, lactic acidosis risk, hypoglycemia, and glycemic control.*

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Formula (Metformin Granules 3)

Chemical structure of Metformin hydrochloride showing its molecular formula with nitrogen, carbon, hydrogen, and chlorine atoms arranged to depict the biguanide chemical configuration typical for this active ingredient.*

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Table 4 (Metformin Granules 4)

A data table presenting pharmacokinetic parameters of Metformin Hydrochloride Tablets in various subject groups. It summarizes the maximum concentration (Cmax), time to maximum concentration (Tmax), and renal clearance rates for doses of 500 mg and 850 mg in healthy adults, adults with type 2 diabetes, elderly healthy adults, and renal-impaired adults categorized by mild, moderate, and severe renal function impairment.*

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Table 5 (Metformin Granules 5)

A data table showing drug interaction information for Metformin hydrochloride tablets. It lists coadministered drugs, their doses, doses of Metformin, and geometric mean ratios for AUC and Cmax comparing with and without the coadministered drug. Drugs with no dosing adjustments required include Glyburide, Furosemide, Nifedipine, Propranolol, and Ibuprofen. Cimetidine and Topiramate are also listed with notes on their effects on Metformin elimination and metabolic acidosis risk.*

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Table 6 (Metformin Granules 6)

A data table comparing the dose of various coadministered drugs and 850 mg dose of metformin, showing geometric mean ratios of AUC and Cmax with and without metformin. It lists glyburide, furosemide, nifedipine, propranolol, ibuprofen, and cimetidine with respective dose details and interaction metrics indicating no dosing adjustments required.*

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Table 7 (Metformin Granules 7)

Data table comparing fasting plasma glucose (FPG) and Hemoglobin A1c (%) baseline values and changes at final visit for Metformin Hydrochloride Tablets (n=141) versus placebo (n=145), including p-values indicating statistical significance for changes.*

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Table 8 (Metformin Granules 8)

A data table presenting clinical study results comparing three groups (Comb, Glyb, MET) on fasting plasma glucose (mg/dL) and hemoglobin A1c (%) at baseline and changes at final visit, including p-values for group comparisons (Glyb vs Comb, MET vs Comb, MET vs Glyb).*

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Table 9 (Metformin Granules 9)

A table comparing fasting plasma glucose (FPG) levels in mg/dL for Metformin Hydrochloride Tablets versus placebo. It shows baseline values, change at final visit, and associated p-value, with sample sizes of 37 for Metformin and 36 for placebo.*

* 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.