Metformin Hydrochloride
Product Images NDC 45865-517

10 FDA label images from Medsource Pharmaceuticals · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Metformin Hydrochloride (NDC 45865-517). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Medsource Pharmaceuticals, 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

Bd3a3e6-1b64-4bda-88db-ae433d17dc8a (0bd3a3e6 1b64 4bda 88db Ae433d17dc8a)

Bd3a3e6-1b64-4bda-88db-ae433d17dc8a (0bd3a3e6 1b64 4bda 88db Ae433d17dc8a)
A data table titled 'Summary of Mean Percent Changes from Baseline in Major Lipid Variables at Final Visit (24-week study)' comparing Metformin Hydrochloride Tablets 500 mg twice daily to Metformin Hydrochloride Extended Release Tablets 1000 mg once and 1500 mg once. It presents baseline values and mean percent changes at final visit for total cholesterol, total triglycerides, LDL-cholesterol, and HDL-cholesterol with sample sizes for each group.*
FDA Label Image

5fec0b40-figure-01 (3657f435 Figure 01)

5fec0b40-figure-01 (3657f435 Figure 01)
Chemical structure diagram of metformin hydrochloride, showing the molecular arrangement of the active ingredient with its hydrochloride salt form indicated.*
FDA Label Image

705cc8a-5055-412c-825a-80a3fd5b9c7a (3705cc8a 5055 412c 825a 80a3fd5b9c7a)

705cc8a-5055-412c-825a-80a3fd5b9c7a (3705cc8a 5055 412c 825a 80a3fd5b9c7a)
A data table summarizing mean changes from baseline in Hemoglobin A1c %, Fasting Plasma Glucose (FPG) mg/dL, and Body Weight (lbs) at week 12 and final visit in a 24-week study comparing Metformin Hydrochloride 500 mg twice daily and Metformin Hydrochloride Extended Release Tablets 1000 mg and 1500 mg once daily.*
FDA Label Image

Pdp (517)

Pdp (517)
Metformin hydrochloride 500 mg tablets label from Medsource Pharmaceuticals, generic for Glucophage. The label shows the product as white round tablets with a bottle count of 30. It includes cautionary text advising dizziness and avoiding alcohol, and directions for use as prescribed by a physician. The label has the NDC 45865-0517.*
FDA Label Image

0403393-33b1-484a-a4d0-8c0a182f0dbd (60403393 33b1 484a A4d0 8c0a182f0dbd)

0403393-33b1-484a-a4d0-8c0a182f0dbd (60403393 33b1 484a A4d0 8c0a182f0dbd)
A data table summarizing mean percent changes from baseline in major serum lipid variables at the final visit of 29-week studies. It compares Metformin Hydrochloride Tablets vs Placebo and Combined Metformin Hydrochloride Tablets/Glyburide vs Monotherapy across variables including total cholesterol, total triglycerides, LDL-cholesterol, and HDL-cholesterol. Baseline values and percent changes at final visit are detailed for each treatment group with sample sizes noted.*
FDA Label Image

Dadc8a7-4fe8-4830-9bd5-82f3a0e5184c (6dadc8a7 4fe8 4830 9bd5 82f3a0e5184c)

Dadc8a7-4fe8-4830-9bd5-82f3a0e5184c (6dadc8a7 4fe8 4830 9bd5 82f3a0e5184c)
A text panel providing patient demographic information and study notes, including mean age of pediatric patients as 13.8 years (range 10 to 16 years), a note that all patients were on diet therapy at baseline, and an indication that some results were not statistically significant.*
FDA Label Image

1c10ce2-2e46-47dd-b7e7-1083fe41137b (71c10ce2 2e46 47dd B7e7 1083fe41137b)

1c10ce2-2e46-47dd-b7e7-1083fe41137b (71c10ce2 2e46 47dd B7e7 1083fe41137b)
A data table summarizing mean changes from baseline in fasting plasma glucose (FPG), hemoglobin A1c, and body weight at the final visit for Metformin Hydrochloride Tablets versus placebo in a 29-week study. Includes baseline and change values for both groups with associated p-values indicating statistical significance.*
FDA Label Image

48c0b5f-a8ef-49a1-9fc4-acb66265226f (748c0b5f A8ef 49a1 9fc4 Acb66265226f)

48c0b5f-a8ef-49a1-9fc4-acb66265226f (748c0b5f A8ef 49a1 9fc4 Acb66265226f)
A data table comparing mean changes in plasma glucose levels (FPG) and body weight between Metformin Hydrochloride Tablets and placebo in a pediatric study group, showing baseline values and changes at final visit with associated p-values.*
FDA Label Image

C630784-d07a-495b-95e7-b3de307bd6c8 (9c630784 D07a 495b 95e7 B3de307bd6c8)

C630784-d07a-495b-95e7-b3de307bd6c8 (9c630784 D07a 495b 95e7 B3de307bd6c8)
A data table comparing mean changes in fasting plasma glucose, hemoglobin A1c, and body weight from baseline to final visit over 29 weeks, for three groups: Combined Metformin Hydrochloride Tablets/Glyburide (Comb), Glyburide (Glyb), and Metformin Hydrochloride Tablets (MET) monotherapy. The table includes sample sizes, baseline values, changes at final visit, and p-values for group comparisons.*
FDA Label Image

2e2c0e5-1dbe-449d-885e-e3a329b03f2e (D2e2c0e5 1dbe 449d 885e E3a329b03f2e)

2e2c0e5-1dbe-449d-885e-e3a329b03f2e (D2e2c0e5 1dbe 449d 885e E3a329b03f2e)
A data table titled 'Combined Metformin Hydrochloride Tablets/Insulin vs Placebo/Insulin Summary of Mean Changes from Baseline in HbA1c and Daily Insulin Dose.' It compares baseline and final visit values for hemoglobin A1c percentage and insulin dose in units per day between two groups: Metformin Hydrochloride Tablets/Insulin (n=26) and Placebo/Insulin (n=28), including treatment differences with standard errors and statistical significance notes.*

* 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.