Dapagliflozin Tablet, Film Coated
Product Images NDC 70954-856

12 FDA label images from Ani Pharmaceuticals, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Dapagliflozin (NDC 70954-856). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Ani Pharmaceuticals, 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.

Product Images & Figures Index

FDA Label Image

Structure (Structure)

Structure (Structure)
Chemical structure diagram of dapagliflozin, showing its molecular arrangement including chlorine and ethoxy groups attached to phenyl rings and multiple hydroxyl groups on a glucose-like ring.*
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Figure One (Figure One)

Figure One (Figure One)
A scatter plot with fitted lines depicting the relationship between dapagliflozin dose (mg, logarithmic scale) and CFB in 24-hr urinary glucose (grams). It shows observed values and fitted lines for healthy subjects and subjects with type 2 diabetes mellitus (T2DM). The x-axis represents dapagliflozin dose and the y-axis represents glucose changes in urine.*
FDA Label Image

Figure Two (Figure Two)

Figure Two (Figure Two)
A line graph illustrating the percent adjusted mean change from baseline in HbA1c (%) over 24 study weeks. The x-axis represents study weeks from 0 to 24, while the y-axis shows HbA1c change from 0.0 to -2.0 percent. Three different data series are plotted using square, triangle, and circle markers, with error bars shown at week 24 (LOCF). A legend identifies the markers but specific group labels are not visible.*
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Figure Three (Figure Three)

Figure Three (Figure Three)
Line graph depicting the adjusted mean change from baseline in HbA1c (%) over 24 study weeks. The x-axis represents study weeks from 0 to 24, and the y-axis shows percentage change. Two data series are shown with different markers, each displaying trends of HbA1c changes including error bars at week 24 (LOCF).*
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Figure Four (Figure Four)

Figure Four (Figure Four)
A line graph comparing the percentage of patients with an event over 60 months from randomization between Dapagliflozin tablets and placebo. Two curves represent the groups: Dapagliflozin tablets show a lower percentage of patients with events compared to placebo over time. The x-axis represents months from randomization, and the y-axis shows the percentage of patients with events. A table below lists patient numbers at risk over different month intervals for both groups.*
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Figure Five (Figure Five)

Figure Five (Figure Five)
This is a Kaplan-Meier curve graph depicting the percentage of patients experiencing an event over time in months from randomization, comparing Dapagliflozin tablets with placebo. The y-axis shows the percentage of patients with an event, and the x-axis tracks duration up to 60 months. Patient counts at risk are listed below the graph for both groups at several time points.*
FDA Label Image

Med Guide One (Med Guide)

Med Guide One (Med Guide)
Partial text panel displaying a bulleted list of symptoms including nausea, vomiting, stomach area (abdominal) pain, tiredness, trouble breathing, and ketones in urine or blood. This appears to be from a patient information or warning section related to the drug Dapagliflozin.*
FDA Label Image

Med-guide-1 (Med Guide 1)

Med-guide-1 (Med Guide 1)
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Med-guide-new (Med Guide New)

Med-guide-new (Med Guide New)
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Med Guide Two (Med Guide Two)

Med Guide Two (Med Guide Two)
A text list detailing possible symptoms such as headache, confusion, hunger, jitteriness, drowsiness, dizziness, fast heartbeat, weakness, sweating, and irritability. The panel appears to be part of a patient information or drug facts section, likely addressing side effects or warning signs related to Dapagliflozin tablets.*
FDA Label Image

Container-5mg-30count (Container Label 5mg 30ct)

Container-5mg-30count (Container Label 5mg 30ct)
Dapagliflozin 5 mg film-coated tablets label from ANI Pharmaceuticals, Inc. The label states the dosage form and strength, storage instructions, pharmacist dispensing advice, and includes the NDC 70954-856-10. It also indicates a bottle size of 30 tablets and warnings regarding the printed inner seal.*
FDA Label Image

Container-10mg-30count (Container Label 10mg 30ct)

Container-10mg-30count (Container Label 10mg 30ct)
Dapagliflozin Tablets, USP 10 mg film-coated tablets label. The label includes dosage strength, pharmacist dispensing instructions, storage conditions at 20ºC to 25ºC with permitted excursions, and warnings about the inner bottle seal. Distributed by ANI Pharmaceuticals, Inc., the package contains 30 tablets for oral use.*

* 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.