Dapagliflozin And Metformin Hydrochloride Tablet, Film Coated, Extended Release
Product Images NDC 72205-434

Product Visual Gallery

This gallery contains 21 technical images submitted to the FDA as part of the official labeling for Dapagliflozin And Metformin Hydrochloride (NDC 72205-434). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Novadoz Pharmaceuticals 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

Dapa-met-10mg-1000mg-30-pack (Dapa Met 10mg 1000mg 30 Pack)

Label for Dapagliflozin and Metformin HCl Extended-Release Tablets, 10 mg/1,000 mg strength. The package contains 30 tablets. Manufactured by MSN Laboratories Private Limited, India, and distributed by Novadoz Pharmaceuticals LLC. The label includes storage instructions and a pharmacist dispensing note. Barcodes are visible on the right side.*

FDA Label Image

Dapa-met-10mg-1000mg-400-pack (Dapa Met 10mg 1000mg 400 Pack)

Label for Dapagliflozin and Metformin HCl Extended-Release Tablets, 10 mg/1,000 mg strength, oral dosage form. The label indicates 400 tablets per container and is labeled by Novadoz Pharmaceuticals LLC. It includes storage instructions, dispensing warnings, manufacturer information (MSN Laboratories, India), and barcodes.*

FDA Label Image

Dapa-met-10mg-1000mg-60-pack (Dapa Met 10mg 1000mg 60 Pack)

Label for Dapagliflozin and Metformin HCl Extended-Release Tablets, 10 mg / 1,000 mg strength. The film-coated oral tablets are prescription-only and come in a 60-tablet bottle. Manufactured by MSN Laboratories Private Limited, India, and distributed by Novadoz Pharmaceuticals LLC, Piscataway, NJ. The label includes storage instructions and tablet use warnings.*

FDA Label Image

Dapa-met-10mg-500mg-30-pack (Dapa Met 10mg 500mg 30 Pack)

Label for Dapagliflozin and Metformin HCl Extended-Release Tablets, 10 mg / 500 mg, containing 30 tablets. The label includes dosage instructions, storage conditions, and manufacturer information, showing MSN Laboratories Private Limited as the manufacturer and Novadoz Pharmaceuticals LLC as the distributor. The label also includes barcodes and a reminder to dispense the accompanying medication guide.*

FDA Label Image

Dapa-met-10mg-500mg-500-pack (Dapa Met 10mg 500mg 500 Pack)

Label for Dapagliflozin and Metformin HCl Extended-Release Tablets containing 10 mg dapagliflozin and 500 mg metformin hydrochloride per tablet. The label indicates 500 tablets per container, manufactured by MSN Laboratories Private Limited, India, and distributed by Novadoz Pharmaceuticals LLC. Instructions include swallowing tablets whole and dispensing the medication guide. Storage temperature and safety warnings are also noted.*

FDA Label Image

Dapa-met-5mg-1000mg-30-pack (Dapa Met 5mg 1000mg 30 Pack)

Label for Dapagliflozin and Metformin HCl Extended-Release Tablets, 5 mg / 1,000 mg strength. The oral tablet container holds 30 film-coated tablets and is distributed by Novadoz Pharmaceuticals LLC. It includes usage storage instructions, manufacturer details, and pharmacist dispensing guidance. The label also features the NDC code 72205-435-01 and multiple barcodes.*

FDA Label Image

Dapa-met-5mg-1000mg-400-pack (Dapa Met 5mg 1000mg 400 Pack)

Label for Dapagliflozin and Metformin HCl Extended-Release Tablets, strength 5 mg / 1,000 mg. The label states a 400 tablet count, manufactured by MSN Laboratories Private Limited, India, and distributed by Novadoz Pharmaceuticals LLC. It includes storage instructions, pharmacist dispensing information, and a barcode.*

FDA Label Image

Dapa-met-5mg-1000mg-60-pack (Dapa Met 5mg 1000mg 60 Pack)

Label for Dapagliflozin and Metformin HCl Extended-Release Tablets, 5 mg / 1,000 mg strength, oral dosage form. The label indicates 60 tablets per bottle. The product is manufactured by MSN Laboratories Private Limited and distributed by Novadoz Pharmaceuticals LLC. Storage instructions and warning against crushing or chewing the tablets are included.*

FDA Label Image

Dapa-met-5mg-500mg-30-pack (Dapa Met 5mg 500mg 30 Pack)

Label for Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets, 5 mg / 500 mg strength, 30 tablets per bottle. The label includes storage instructions, manufacturer MSN Laboratories Private Limited (India), and distributor Novadoz Pharmaceuticals LLC (New Jersey). It features dosage warnings and pharmacist instructions along with multiple barcodes.*

FDA Label Image

Dapa-met-5mg-500mg-500-pack (Dapa Met 5mg 500mg 500 Pack)

Label for Dapagliflozin and Metformin HCl Extended-Release Tablets, 5 mg / 500 mg, oral dosage form. The label indicates a package containing 500 tablets, distributed by Novadoz Pharmaceuticals LLC, Piscataway, NJ, and manufactured by MSN Laboratories Private Limited, India. It includes dosing instructions, storage conditions, and a pharmacist advisory.*

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Dapa-met-dapagliflozin-structure (Dapa Met Dapagliflozin Structure)

Chemical structure diagram showing the molecular structure of the active ingredient in Dapagliflozin and Metformin Hydrochloride combination.*

FDA Label Image

Figure-01 (Dapa Met Figure 01)

A scatter plot with fitted lines showing 24-hour urinary glucose (g) versus dapagliflozin dose (mg). Observed values for healthy subjects and subjects with type 2 diabetes mellitus (T2DM) are plotted with different symbols, alongside fitted lines representing trends for both groups.*

FDA Label Image

Figure-02 (Dapa Met Figure 02)

A line graph depicting adjusted mean change from baseline in HbA1c (%) over a 24-week study period comparing Dapagliflozin 10 mg plus Metformin XR, Dapagliflozin 10 mg alone, and Metformin XR alone. The x-axis represents study weeks and the y-axis shows HbA1c percentage change. Data include longitudinal repeated measures and 95% confidence intervals at week 24 (LOCF).*

FDA Label Image

Figure-03 (Dapa Met Figure 03)

A line graph showing adjusted mean change in HbA1c (%) from baseline over 24 weeks comparing Placebo + Metformin and Dapagliflozin 10 mg + Metformin. The x-axis represents study weeks, and the y-axis shows percent change. Symbols distinguish the two groups, with inset error bars indicating 95% confidence intervals at week 24 (LOCF).*

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Fig4 (Dapa Met Figure 04)

A line graph comparing the percentage of patients with an event over time between Dapagliflozin and placebo groups. The x-axis represents months from randomization, and the y-axis shows percent of patients with an event. Two lines indicate outcomes for Dapagliflozin and placebo, with patient counts at risk provided below the graph for several time points up to 60 months.*

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Fig5 (Dapa Met Figure 05)

A Kaplan-Meier curve showing the percentage of patients with an event over time (months from randomization) comparing Dapagliflozin to placebo. The graph plots patients at risk at various time points, illustrating event occurrence trends for Dapagliflozin and placebo groups over approximately 60 months.*

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Dapa-met-figure-06 (Dapa Met Figure 06)

A Kaplan-Meier curve comparing the percentage of patients with an event over time (in months) from randomization between Dapagliflozin and Placebo groups. The graph shows event percentages on the y-axis and months on the x-axis, with the Placebo group having higher event rates. Patient risk counts at various time points for both groups are listed below the chart.*

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Dapa-met-figure-07a (Dapa Met Figure 07a)

A line graph showing the percentage of patients with an event over 24 months from randomization, comparing Dapagliflozin and placebo groups. The x-axis represents months from randomization, and the y-axis shows the percentage of patients with the event. Two lines represent the Dapagliflozin group and placebo group, with patient counts at risk listed below the x-axis over time.*

FDA Label Image

Dapa-met-figure-07b (Dapa Met Figure 07b)

A line graph comparing the percentage of patients experiencing an event over 36 months from randomization between dapagliflozin and placebo groups. The graph includes a hazard ratio (HR) with 95% confidence interval and a p-value showing statistical comparison between dapagliflozin and placebo. Patient counts at risk are shown below the x-axis at various time points.*

FDA Label Image

Dapa-met-figure-08 (Dapa Met Figure 08)

A forest plot comparing the hazard ratios (HR) with 95% confidence intervals (CI) for dapagliflozin versus placebo across two studies (DAPA-HF and DELIVER). The plot shows HR categories by left ventricular ejection fraction (LVEF %) ranges, with numeric values for events and sample sizes for both dapagliflozin and placebo groups.*

FDA Label Image

Dapa-met-metformin-structure (Dapa Met Metformin Structure)

Chemical structure of metformin hydrochloride, showing its molecular arrangement including methyl groups, nitrogen atoms, and hydrochloride component.*

* 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.