Dabigatran Etexilate Capsule
Product Images NDC 43598-641

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Dabigatran Etexilate (NDC 43598-641). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Dr.reddys Laboratories 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.

FDA Label Image

Container1 (Container1)

Container1 (Container1)
This text provides information about a medication called Dabigatran Etexilate Capsules in 75mg strength. It includes instructions on how to take the capsules, storage guidelines, and a warning about not substituting with other forms of dabigatran etexilate. The packaging details and manufacturer information are also included. It is crucial to follow the instructions provided and store the medication in a cool, dry place away from children.*
FDA Label Image

Container2 (Container2)

Container2 (Container2)
This text provides detailed information about Dabigatran Etexilate Capsules at a dosage of 110 mg. It includes instructions on how to use the product, storage conditions, dosage information, and guidance for pharmacists on dispensing the capsules. The text also mentions that the capsules should be used within 4 months once opened and that they are not substitutable with other forms of dabigatran etexilate on a mg-to-mg basis. Additionally, it gives details on the manufacturer, distributor, and a unique identifier code.*
FDA Label Image

Container3 (Container3)

Container3 (Container3)
This text is a description of Dabigatran Etexilate Capsules with a dosage of 150 mg per capsule. It includes instructions on usage, storage, and handling of the medication, and mentions that the capsules should be used within 4 months of opening. The text emphasizes that the capsules are not interchangeable with other forms of dabigatran etexilate. It also provides details on the manufacturer, dosage information, temperature for storage, and a reminder to keep the capsules out of reach of children.*
FDA Label Image

Figure1 (Figure1)

FDA Label Image

Figure2 (Figure2)

Figure2 (Figure2)
This text provides information related to the aPTT time course for the use of Dabigatran Etexilate at different doses based on the patient's Creatinine Clearance (C1Cl) levels. The doses mentioned are 150 mg BID when C1CI is greater than 30 ml/min and 75 mg BID when C1Cl is less than 30 ml/min. Additionally, there is a graphical representation showing the time course for different Creatinine Clearance levels.*
FDA Label Image

Figure3a (Figure3a)

FDA Label Image

Figure3b (Figure3b)

Figure3b (Figure3b)
This text appears to be detailing a list of drugs, doses, and time differences in a study or evaluation. The drugs mentioned include Atorvastatin, Clopidogrel, Diclofenac, Digoxin, Enalapril, Pantoprazole, and Ranitidine. The information seems to also refer to dosing regimens such as once daily (qd), single dose (SD), twice daily (bid), and the duration of treatment. The text may also mention fold change and confidence interval, possibly indicating data related to the efficacy or interactions of the drugs.*
FDA Label Image

Figure4 (Figure4)

Figure4 (Figure4)
This is a table showing the estimated cumulative probability of an event over time from randomization in months. The data includes the number of subjects at risk for two different dosages of a drug and for warfarin. The subjects are at risk at various time points ranging from 0 to 39 months. The table provides information on the number of subjects at risk at each time point for DE at 110 mg bid, DE at 150 mg bid, and Warfarin.*
FDA Label Image

Figure5 (Figure5)

FDA Label Image

Structure (Structure)

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