Dapagliflozin Tablet
Product Images NDC 33342-586

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Dapagliflozin (NDC 33342-586). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Macleods Pharmaceuticals Limited, 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

336 (Dapagliflozin 10 mg 140 S)

Dapagliflozin Tablets 10 mg oral film-coated tablets packaging label from Macleods Pharmaceuticals Limited. The label includes the product name and strength prominently, with details stating 140 tablets in 14 blister cards of 10 tablets each. Manufactured in India and labeled for Macleods Pharma USA, Inc. Additional storage instructions and warnings are also included on the packaging.*

FDA Label Image

852 (Dapagliflozin 10 mg 30 S)

Label for Dapagliflozin Tablets 10 mg oral tablets by Macleods Pharmaceuticals Limited. The label shows 30 tablets per bottle with storage instructions between 20° to 25°C and a note to keep out of reach of children. Manufactured in India and distributed by Macleods Pharma USA, Inc.*

FDA Label Image

564 (Dapagliflozin 10 mg 90 S)

Label for Dapagliflozin Tablets 10 mg oral tablets, containing 90 tablets per package. The label indicates the product is manufactured for Macleods Pharma USA, Inc. and by Macleods Pharmaceuticals Ltd. in India. Storage instructions and safety warnings about the bottle seal are also visible.*

FDA Label Image

448 (Dapagliflozin 5 mg 100 S)

Packaging label for Dapagliflozin Tablets 5 mg, an oral tablet product from Macleods Pharmaceuticals USA. The label shows a package containing 100 tablets in 10 blister cards with 10 tablets each. It includes storage instructions, manufacturer information, a barcode, and dosing reference to the prescribing information.*

FDA Label Image

723 (Dapagliflozin 5 mg 30 S)

Label for Dapagliflozin Tablets 5 mg oral tablets, manufactured by Macleods Pharmaceuticals Limited. The label includes dosage strength, storage instructions (20° to 25°C), pharmacist dispensing information, and manufacturer details from India. The package contains 30 tablets and advises keeping out of reach of children.*

FDA Label Image

656 (Dapagliflozin 5 mg 90 S)

Label for dapagliflozin tablets 5 mg by Macleods Pharmaceuticals Limited. The label states each film-coated tablet contains 5 mg dapagliflozin. It includes storage instructions, manufacturer information for Macleods Pharma USA and Macleods Pharmaceuticals Ltd, and specifies a package size of 90 tablets.*

FDA Label Image

505 (Dapagliflozin Fig 1)

A scatter plot graph showing observed values and fitted lines for 24-hour urinary glucose excretion (CFB) versus dapagliflozin dose in mg. The plot differentiates between healthy subjects and subjects with type 2 diabetes mellitus (T2DM) using different markers and fitted lines to represent their responses across a range of doses from 0.0001 to 1000 mg.*

FDA Label Image

658 (Dapagliflozin Fig 2)

A line chart comparing adjusted mean percent change from baseline in HbA1c over 24 weeks for three groups: dapagliflozin 10 mg plus metformin, dapagliflozin 10 mg alone, and metformin alone. The study week is on the x-axis, and HbA1c percent change is on the y-axis, showing progressive reduction in all groups with dapagliflozin plus metformin having the greatest decrease.*

FDA Label Image

575 (Dapagliflozin Figure 3)

A line graph showing the adjusted mean change in HbA1c (%) from baseline over 24 study weeks for two groups: Placebo + Metformin and Dapagliflozin 10 mg + Metformin. The Dapagliflozin group shows a greater reduction in HbA1c compared to placebo. The graph includes error bars representing 95% confidence intervals at week 24 (LOCF).*

FDA Label Image

505 (Dapagliflozin Figure 4)

A cumulative incidence graph depicting the percentage of patients with an event over months from randomization for dapagliflozin versus placebo groups. The y-axis represents patients with events (%) and the x-axis shows months from randomization up to about 54 months. Two step curves labeled "DAPAGLIFOZIN" (solid) and "Placebo" (dotted) illustrate lower event incidence over time with dapagliflozin compared to placebo. Below the graph numbers indicate patients at risk for both groups over time.*

FDA Label Image

505 (Dapagliflozin Figure 5)

A line graph showing the percentage of patients with an event over time in months from randomization comparing dapagliflozin and placebo groups. The y-axis represents patients with event (%) from 0.0 to 4.5%, and the x-axis shows months from 0 to 60. Two lines represent dapagliflozin and placebo, with data points for patients at risk listed below the graph.*

FDA Label Image

556 (Dapagliflozin Stru)

Chemical structure diagram of dapagliflozin, showing its molecular components and arrangement including hydroxyl groups, chloride-substituted aromatic ring, and ether linkages.*

* 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.