Dapagliflozin And Metformin Hydrochloride Tablet, Extended Release
Product Images NDC 33342-408

Product Visual Gallery

This gallery contains 31 technical images submitted to the FDA as part of the official labeling for Dapagliflozin And Metformin Hydrochloride (NDC 33342-408). 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

505 (Dapa Met Er 10mg 1000mg 30s Container)

Dapagliflozin and Metformin HCl Extended-Release Tablets 10 mg/1000 mg by Macleods Pharmaceuticals Limited. The label indicates the package contains 30 tablets with storage instructions and cautions for tablet use. Manufactured for Macleods Pharma USA, Inc., Princeton, NJ 08540, and produced in India.*

FDA Label Image

505 (Dapa Met Er 10mg 1000mg 500s Container)

Label for Dapagliflozin and Metformin HCl Extended-Release Tablets, strength 10 mg/1000 mg, oral dosage form. The package contains 500 tablets and is labeled for Macleods Pharma USA, Inc. It includes storage instructions and safety warnings. The label notes the product is manufactured by Macleods Pharmaceuticals Ltd in India.*

FDA Label Image

1515 (Dapa Met Er 10mg 1000mg 60s Container)

Label for Dapagliflozin and Metformin HCl Extended-Release Tablets 10 mg/1000 mg from Macleods Pharmaceuticals Limited. The oral tablet packaging contains 60 tablets. The label includes storage instructions, manufacturer details, and a pharmacist note. The product is manufactured for Macleods Pharma USA, Inc., Princeton, NJ, and Macleods Pharmaceuticals Ltd., India.*

FDA Label Image

505 (Dapa Met Er 10mg 1000mg 90s Container)

Label for Dapagliflozin and Metformin HCl Extended-Release Tablets 10 mg/1000 mg by Macleods Pharmaceuticals Limited. The label states the dosage form as extended-release tablets, the quantity as 90 tablets, and includes storage instructions. Manufactured for Macleods Pharma USA, Inc., Princeton, NJ, and by Macleods Pharmaceuticals Ltd., India.*

FDA Label Image

1717 (Dapa Met Er 10mg 1000mg Carton Tablets)

Packaging label for Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets, 10 mg/1000 mg strength. The label displays the product name, strength, dosage form (extended-release tablets), and directions indicating the tablets must be swallowed whole. The labeler is Macleods Pharmaceuticals Limited, with manufacturing by Macleods Pharma USA, Inc. The package contains 30 tablets in unit-dose format, with storage instructions and a barcode included.*

FDA Label Image

505 (Dapa Met Er 10mg 500mg 30s Container)

Label for Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets, 10 mg/500 mg strength, in a 30-tablet package. The label includes storage instructions, directions to see package insert for dosage, and manufacturer information for Macleods Pharmaceuticals Limited, India, and Macleods Pharma USA, Inc. The label also cautions against crushing or chewing tablets.*

FDA Label Image

505 (Dapa Met Er 10mg 500mg 500s Container)

Label for Dapagliflozin and Metformin HCl Extended-Release Tablets, 10 mg/500 mg strength, by Macleods Pharmaceuticals Limited. The label notes each tablet contains 10 mg dapagliflozin and 500 mg metformin hydrochloride. It instructs storage conditions and includes warnings about crushing or chewing tablets and packaging safety. The product is manufactured for Macleods Pharma USA, Inc.*

FDA Label Image

505 (Dapa Met Er 10mg 500mg 60s Container)

Label for Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets, 10 mg/500 mg strength, oral dosage form. The label shows the product name, strength, and form, with a package quantity of 60 tablets. The labeler is Macleods Pharmaceuticals Limited, manufactured for Macleods Pharma USA, Inc., Princeton, NJ. Storage instructions and a pharmacist dispensing notice are also displayed.*

FDA Label Image

505 (Dapa Met Er 10mg 500mg 90s Container)

Label for Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets, 10 mg/500 mg, by Macleods Pharmaceuticals Limited. The label includes dosage form and strength, storage instructions, pharmacist dispensing info, product origin (India), and manufacturer details for Macleods Pharma USA, Inc. It indicates a package size of 90 tablets and features barcodes on both sides.*

FDA Label Image

8888 (Dapa Met Er 10mg 500mg Carton Tablets)

Carton label for Dapagliflozin and Metformin HCl Extended-Release Tablets 10 mg/500 mg by Macleods Pharmaceuticals Limited. The label shows tablet strength, extended-release form, package quantity of 30 tablets (3 x 10 unit-dose), and instructions stating tablets must be swallowed whole. Manufactured for Macleods Pharma USA, Inc.*

FDA Label Image

505 (Dapa Met Er 5mg 1000mg 30s Container)

Label for Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets 5 mg/1000 mg by Macleods Pharmaceuticals Limited. The label states it contains 30 tablets for oral use, with storage instructions and dosage guidance directing users to the package insert. The product is manufactured for Macleods Pharma USA, Inc., Princeton, NJ, and made in India.*

FDA Label Image

505 (Dapa Met Er 5mg 1000mg 500s Container)

Label for Dapagliflozin and Metformin HCl Extended-Release Tablets, 5 mg/1000 mg strength, oral dosage form. The label specifies 500 tablets and includes storage instructions, dispensing guidance, and manufacturer information for Macleods Pharma USA, Inc. and Macleods Pharmaceuticals Ltd., India.*

FDA Label Image

505 (Dapa Met Er 5mg 1000mg 60s Container)

Label for Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets, strength 5 mg/1000 mg. The oral tablet packaging contains 60 tablets, manufactured by Macleods Pharmaceuticals Ltd. The label includes dosage storage instructions, pharmacist guidance, and product origin information, listing Macleods Pharma USA, Inc. as the manufacturer for distribution.*

FDA Label Image

505 (Dapa Met Er 5mg 1000mg 90s Container)

Dapagliflozin and Metformin HCl Extended-Release Tablets label for 5 mg/1000 mg strength. The label specifies the dosage form as extended-release tablets, intended for oral use, with 90 tablets per bottle. It includes storage instructions and manufacturer information for Macleods Pharmaceuticals Limited, along with a pharmacist note to dispense an accompanying medication guide.*

FDA Label Image

1313 (Dapa Met Er 5mg 1000mg Carton Tablets)

Packaging label for Dapagliflozin and Metformin Hydrochloride 5 mg/1000 mg extended-release tablets. The oral medication is supplied in unit-dose packaging with 30 tablets per carton. The label shows the product name, strength, dosage form, NDC 33342-408-06, manufacturer Macleods Pharmaceuticals Limited, and distributor Macleods Pharma USA, Inc., Princeton, NJ. The label includes storage instructions and a barcode.*

FDA Label Image

505 (Dapa Met Er 5mg 500mg 30s Container)

Label for Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets, 5 mg/500 mg strength, from Macleods Pharmaceuticals Limited. The label includes dosage information, storage instructions, and manufacturer details. It specifies that the package contains 30 tablets and is intended for oral use. The label also shows the NDC code 33342-406-07 and highlights the medication guide availability online.*

FDA Label Image

505 (Dapa Met Er 5mg 500mg 500s Container)

Label for Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets 5 mg/500 mg by Macleods Pharmaceuticals Limited. The label states 500 tablets, with dosage, storage instructions, manufacturer information, and usage precautions. It includes barcodes and a pharmacist advisory.*

FDA Label Image

505 (Dapa Met Er 5mg 500mg 60s Container)

Label for Dapagliflozin and Metformin HCl Extended-Release Tablets 5 mg/500 mg, featuring the product name, strength, dosage form, and quantity of 60 tablets. Manufactured by Macleods Pharmaceuticals Ltd and labeled for Macleods Pharma USA, Inc. The label includes storage instructions, usage cautions, and directs pharmacists to provide a medication guide. It highlights the tablet composition and product origin as India.*

FDA Label Image

505 (Dapa Met Er 5mg 500mg 90s Container)

Label for Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets, strength 5 mg/500 mg, oral tablets. The label includes storage instructions, pharmacist dispensing guidance, and manufacturer information for Macleods Pharmaceuticals Limited and Macleods Pharma USA, with a package count of 90 tablets. It notes the product is made in India and includes multiple barcodes.*

FDA Label Image

3333 (Dapa Met Er 5mg 500mg Carton Tablets)

Packaging label for Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets with a strength of 5 mg/500 mg. The package is a box designed for unit-dose tablets, containing 30 tablets (3 x 10). The label displays the manufacturer as Macleods Pharmaceuticals Limited and Macleods Pharma USA, Inc. with directions for storage and pharmacist instructions.*

FDA Label Image

Dapa (Dapa Met Er Dapagliflozin Str)

Chemical structure diagram of the active ingredient dapagliflozin in Dapagliflozin and Metformin Hydrochloride extended release tablets. The diagram shows atoms and bonds forming the molecular structure, including hydroxyl groups and a chlorophenyl group.*

FDA Label Image

505 (Dapa Met Er Figur 1)

A scatter plot graph showing the relationship between dapagliflozin dose (mg, logarithmic scale) on the x-axis and the amount of CFB in 24-hour urinary glucose (g) on the y-axis. The graph presents observed values for healthy subjects and subjects with Type 2 diabetes mellitus (T2DM), with fitted lines for both groups illustrating the dose-response trend.*

FDA Label Image

505 (Dapa Met Er Figure 2)

A line graph illustrating the adjusted mean change from baseline in HbA1c (%) over 24 weeks for three treatment groups: Dapagliflozin 10 mg plus Metformin XR, Dapagliflozin 10 mg, and Metformin XR. The x-axis represents study weeks, and the y-axis represents HbA1c percentage change. The right side presents values at week 24 using last observation carried forward (LOCF) with error bars. A legend identifies the three groups by different symbols.*

FDA Label Image

505 (Dapa Met Er Figure 3)

A line graph showing adjusted mean changes in HbA1C percentage from baseline over 24 study weeks. It compares two groups: Placebo plus Metformin and Dapagliflozin 10 mg plus Metformin. The graph includes marker symbols for each group and error bars for the 24-week (LOCF) values, with a legend identifying the groups.*

FDA Label Image

505 (Dapa Met Er Figure 6)

A line graph comparing the percentage of patients with an event over 32 months from randomization between Dapagliflozin and Placebo groups. The y-axis represents patients with events (%) and the x-axis shows months. The graph shows fewer events in the Dapagliflozin group compared to Placebo, with patient numbers decreasing over time for both groups.*

FDA Label Image

505 (Dapa Met Er Figure 7a)

A Kaplan-Meier curve comparing the percentage of patients with an event over time in months from randomization between Dapagliflozin and Placebo groups. Two lines show patients with events, with Placebo having a higher event rate than Dapagliflozin. The graph includes hazard ratio (HR 0.74), confidence interval, and p-value (<0.0001), along with the number of patients at risk at various time points.*

FDA Label Image

505 (Dapa Met Er Figure 7b)

A Kaplan-Meier curve showing the percentage of patients with an event over 36 months from randomization, comparing dapagliflozin and placebo groups. The chart includes hazard ratio, confidence interval, and p-value, with patient counts at risk over time for both groups listed below the x-axis.*

FDA Label Image

505 (Dapa Met Er Figure 8)

A forest plot comparing hazard ratios (HR) with 95% confidence intervals for Dapagliflozin versus placebo across different left ventricular ejection fraction (LVEF) percentage categories from DAPA-HF and DELIVER studies. The x-axis ranges from 0.5 to 2, showing point estimates and confidence intervals representing effectiveness of Dapagliflozin relative to placebo.*

FDA Label Image

525 (Dapa Met Er Figure4)

A line graph comparing the percentage of patients with events over time (months from randomization) between Dapagliflozin and Placebo groups. The x-axis shows months from 0 to 60, and the y-axis shows percentage of patients with event from 0 to 7%. Two lines depict event rates: a solid line for Dapagliflozin and a dotted line for Placebo, with Placebo generally higher. Patient counts at risk for both groups are listed below the time points.*

FDA Label Image

505 (Dapa Met Er Figure5)

A Kaplan-Meier plot showing the percentage of patients with events over months from randomization comparing Dapagliflozin and Placebo groups. The y-axis represents patients with events (%) and the x-axis shows time in months up to 60. The graph includes a table of patients at risk at various time points for both groups, illustrating a lower event rate for Dapagliflozin compared to Placebo.*

FDA Label Image

Dapa-met-er-met-structure (Dapa Met Er Metformin Structure)

Chemical structure depicting Metformin Hydrochloride, showing the arrangement of nitrogen, carbon, hydrogen atoms, and the hydrochloride (HCl) component prominently labeled on the right side.*

* 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.