Dabigatran Etexilate Capsule
Product Images NDC 31722-621

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Dabigatran Etexilate (NDC 31722-621). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Camber 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.

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Dabigatrancap150mgcontcarton (Dabigatrancap150mgcontcarton)

This text contains the prescribing information for Dabigatran Etexilate Capsules, a medication used to prevent blood clots in individuals with atrial fibrillation. Each capsule contains 172.95 mg T X Mfg. Dosage instructions and storage recommendations are provided, along with contact numbers for the manufacturer. The text also includes some production details and an identifying number.*

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Dabigatrancap150mgcontlabel (Dabigatrancap150mgcontlabel)

Camber's Dabigatran Etexilate Capsules are dispensed in a container that contains 60 capsules. Each capsule contains 172.95 mg dabigatran etexilate mesylate, which is equivalent to 150mg of dabigatran etexilate. It is necessary to check the package insert for guidance on the right dose to take. It is stored at a temperature between 20°C to 25°C (68°F to 77°F) in the original package to shield it from moisture. If the broken seal is discovered or missing, don't use these pills. Once you open the bottle, you should use the prescription within four months.*

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Dabigatrancap75mgcontcarton (Dabigatrancap75mgcontcarton)

This text provides information related to medication in the form of capsules containing dabigatran etexilate. The capsules have a dosage of 86.48 mg and the pack contains 60 capsules. The dosage instructions are mentioned on the package insert. The capsules should be stored at a temperature of 20° to 25°C and protected from moisture. Once the safety seal is broken, the capsules should be used within 4 months. The manufacturer's address is HETERO LABS LIMITED, Hyderabad, India. Contact details for the US are provided. A medication guide is available upon request, and the medication should be kept out of reach of children.*

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Dabigatrancap75mgcontlabel (Dabigatrancap75mgcontlabel)

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Dabigatrancapcamberlogo1 (Dabigatrancapcamberlogo1)

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Dabigatrancapcamberlogo2 (Dabigatrancapcamberlogo2)

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Dabigatrancapfig5

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Dabigatrancapfigure1 (Dabigatrancapfigure1)

This appears to be a table of data related to the comparison of the occurrence of major bleeding events in patients taking dabigatran 150 and warfarin, separated by different subgroups such as VKA use, age, gender, weight, history of stroke/TIA, diabetes at baseline, CHADS2 score, CrCL, region, and ASA use at baseline. The table includes the number of patients in each subgroup, the number of patients experiencing major bleeding events per year for each drug, and the Hazard Ratio & 95% CT for comparison.*

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Dabigatrancapfigure2 (Dabigatrancapfigure2)

This text appears to be describing the recommended dosages of a medication called Dabigatran etexilate capsules, based on a patient's creatinine clearance (CrCl) level. The recommended dose is 150 mg twice daily when the CrCl is greater than 30 mL/min, and 75 mg twice daily when the CrCl is less than 30 mL/min. The text also includes a graph showing the time course for activated partial thromboplastin time (aPTT) for this medication over a 96-hour period.*

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Dabigatrancapfigure3-1 (Dabigatrancapfigure3 1)

This is a table with information related to different drugs and their interactions, specifically regarding Time Difference PK and Fold Change with 90% CI. The drugs listed include Dronedarone, Ketoconazole, Amiodarone, Clasithromycin, Quinidine, Ticagrelor, Verapamil, and Rifampicin. The table reports dosages, administration frequency, and the effect of the interaction in relation to a reference value. The purpose of this table is likely to inform medical professionals about the interactions between these drugs, which may be useful for therapy planning and patient safety.*

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Dabigatrancapfigure3-2 (Dabigatrancapfigure3 2)

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Dabigatrancapfigure4 (Dabigatrancapfigure4)

This appears to be a graph with three lines or curves that represent the estimated cumulative probability of some event over time. The event is not specified in this text. The graph shows data points at different time intervals, ranging from 18 to 39 months from randomization. Each line or curve represents a different treatment group: DE 110mg bid, DE 150mg bid, and Warfarin. The number of subjects at risk at each time point is also provided for each group. The meaning and context of this graph is not clear and requires additional information.*

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Dabigatranstructure (Dabigatranstructure)

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.