Metformin Hydrochloride
Product Images NDC 12634-757

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Metformin Hydrochloride (NDC 12634-757). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Apotheca 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

Label500 (756 18)

Metformin Hydrochloride 500mg tablets label from Apotheca Inc. The label indicates a bottle containing 180 tablets. It includes NDC numbers 12634-756-18 and 12634-756-19, instructions to compare to Glucophage, and mentions the product is dispensed in a tight, light-resistant container with a child-resistant closure. Directions for use are to take tablets by mouth as directed by a physician. Additional information includes bulk source data and storage conditions.*

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Label850 (757 18)

Metformin Hydrochloride 850 mg tablet label from Apotheca Inc. The label states the product contains 180 tablets with NDC 12634-757-18. It provides storage instructions, prescription warnings, and dispensing information including child-resistant closure. Directions indicate oral administration as prescribed by a physician. The label compares the product to Glucophage and includes manufacturer details and contact for reporting side effects.*

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Label1000 (789 18)

Metformin Hydrochloride 1000 mg label for 180 tablets by Apotheca Inc. The label includes NDC 12634-789-18, lot and expiration date fields, directions for use by mouth as directed by a physician, storage instructions, and a notice to keep medication out of reach of children. It compares to Glucophage and notes the container is child resistant and light resistant.*

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Table1 (Table1)

Table presenting select mean pharmacokinetic parameters of Metformin Hydrochloride tablets following single or multiple oral doses. It includes data on peak plasma concentration (Cmax), time to peak concentration (Tmax), and renal clearance categorized by subject groups such as healthy non-diabetic adults, adults with type 2 diabetes, elderly non-diabetic adults, and renal-impaired adults with varying degrees of creatinine clearance.*

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Table2 (Table2)

A data table summarizing mean changes from baseline in fasting plasma glucose, hemoglobin A1c, and body weight at final visit in a 29-week study comparing Metformin Hydrochloride tablets (n=141) versus placebo (n=145). The table includes baseline measurements and changes at final visit, with p-values indicating statistical significance for glucose and hemoglobin A1c changes, but not body weight.*

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Table3 (Table3)

A data table summarizing results from a 29-week study comparing Metformin Hydrochloride Tablets (MET) monotherapy, Glyburide (Glyb), and a combination of Metformin Hydrochloride and Glyburide (Comb). The table shows baseline values and changes at final visit for fasting plasma glucose, hemoglobin A1c, and body weight across different treatment groups, including associated p-values for statistical comparisons.*

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Table4 (Table4)

A data table titled 'Summary of Mean Percent Change From Baseline of Major Serum Lipid Variables at Final Visit (29-week studies).' It compares mean percent changes in total cholesterol, total triglycerides, LDL-cholesterol, and HDL-cholesterol levels among groups taking Metformin Hydrochloride tablets, placebo, and combined therapies involving Metformin Hydrochloride with Glyburide.*

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Table5 (Table5)

A data table comparing the combined effects of Metformin Hydrochloride Tablets with insulin versus placebo with insulin on mean changes from baseline in Hemoglobin A1c percentage and daily insulin dose. It shows baseline values, changes at the final visit, and treatment difference means with standard errors, including notes on statistical significance.*

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Table6 (Table6)

Data table titled 'Metformin Hydrochloride Tablets vs Placebo (Pediatrics) Summary of Mean Changes from Baseline in Plasma Glucose and Body Weight at Final Visit.' It compares fasting plasma glucose (FPG) and body weight changes from baseline to final visit for Metformin Hydrochloride tablets and placebo groups in pediatric patients aged 10 to 16. Includes sample sizes, baseline values, changes at final visit, and p-values indicating statistical significance.*

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Metformin Structure (Metformin Struct)

Chemical structure diagram of Metformin Hydrochloride showing its molecular composition including methyl groups and guanidine core with hydrochloride.*

* 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.