Pradaxa Pellet
Product Images NDC 0597-0445

23 FDA label images from Boehringer Ingelheim Pharmaceuticals, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 23 technical images submitted to the FDA as part of the official labeling for Pradaxa (NDC 0597-0445). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Boehringer Ingelheim 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.

FDA Label Image

Chemical Structure (Pradaxa 01)

Chemical Structure (Pradaxa 01)
Chemical structure diagram of dabigatran etexilate, the active ingredient in Pradaxa. The structure shows various rings and functional groups characteristic of the molecule, including aromatic rings and ester linkages, as well as the mesylate (CH3SO3) group.*
FDA Label Image

Figure 1 (Pradaxa 02)

Figure 1 (Pradaxa 02)
A forest plot chart showing the pharmacokinetic fold change and 90% confidence intervals (CI) for interacting drugs with Pradaxa (dabigatran etexilate). The chart compares area under the curve (AUC) and maximum concentration (Cmax) for various P-gp inhibitors and inducers, including dronedarone, ketoconazole, amiodarone, clarithromycin, quinidine, ticagrelor, verapamil, and rifampicin, relative to reference values. The x-axis represents the change relative to reference on a logarithmic scale from 0.25 to 4.0.*
FDA Label Image

Figure 2 (Pradaxa 03)

Figure 2 (Pradaxa 03)
A pharmacokinetic chart showing fold changes and 90% confidence intervals for various interacting drugs relative to a reference. It includes drugs such as Atorvastatin, Clopidogrel, Diclofenac, Digoxin, Enoxaparin, Pantoprazole, and Ranitidine, with measurements for AUC and Cmax depicted on a horizontal axis ranging approximately from 0.5 to 2.0 fold change.*
FDA Label Image

Figure (Pradaxa 04)

Figure (Pradaxa 04)
An instructional diagram showing a hand holding a spoon labeled "2 teaspoons" above a bowl with an arrow indicating pouring the contents from the spoon into the bowl. A jar with a blank label is shown on the left side, implying measurement of pellet dosage into the bowl.*
FDA Label Image

Figure (Pradaxa 05)

Figure (Pradaxa 05)
An instructional illustration showing silica gel desiccant packets labeled 'Do not eat' being disposed of in a trash container. The image emphasizes proper disposal of the desiccant from pharmaceutical packaging.*
FDA Label Image

Figure (Pradaxa 06)

Figure (Pradaxa 06)
Illustration of a hand holding three individual packets of Pradaxa, an oral pellet formulation containing dabigatran etexilate. The image shows the shape and size of the single-dose sachets for the prescription medication.*
FDA Label Image

Figure (Pradaxa 07)

Figure (Pradaxa 07)
An instructional line drawing showing a hand holding a rectangular oral pellet pouch labeled with 'Pradaxa.' The illustration highlights squeezing the pouch edges as part of the usage instructions for Pradaxa pellets by Boehringer Ingelheim Pharmaceuticals, Inc.*
FDA Label Image

Figure (Pradaxa 08)

Figure (Pradaxa 08)
An instructional line drawing showing two hands; one holds a packet, and the other uses scissors to cut open the packet. The image likely demonstrates how to open a single-use packet or pouch containing a medical product.*
FDA Label Image

Figure (Pradaxa 09)

Figure (Pradaxa 09)
An instructional illustration showing a hand emptying the contents of a sachet containing pellet-form medication into a bowl next to an open bottle. The image demonstrates how to dispense Pradaxa (dabigatran etexilate) pellets for oral administration.*
FDA Label Image

Figure (Pradaxa 10)

Figure (Pradaxa 10)
An instructional illustration showing a hand stirring contents in a bowl with a spoon, next to a medicine bottle. The image visually represents the preparation or mixing of an oral pharmaceutical pellet formulation, such as Pradaxa (dabigatran etexilate) pellets, for administration.*
FDA Label Image

Figure (Pradaxa 11)

Figure (Pradaxa 11)
An instructional illustration showing a hand holding a spoon with pellets approaching the open mouth of a baby, indicating administering oral pellet medication to a child.*
FDA Label Image

Figure (Pradaxa 12)

Figure (Pradaxa 12)
An instructional illustration showing the disposal of a silica gel desiccant packet labeled "DO NOT EAT." The diagram directs to discard the silica gel container into a trash receptacle and not consume it, emphasizing safe handling of the desiccant included with Pradaxa (dabigatran etexilate) pellets packaging.*
FDA Label Image

Figure (Pradaxa 13)

Figure (Pradaxa 13)
An instructional illustration showing a hand holding three small sachets or packets, likely representing medication doses or single-use packaging for oral administration.*
FDA Label Image

Figure (Pradaxa 14)

Figure (Pradaxa 14)
An instructional line drawing showing a hand holding a rectangular pellet, pinching the pellet's sealed edges, likely demonstrating how to open or handle the oral pellet dosage form of Pradaxa (dabigatran etexilate). No text or additional details are visible.*
FDA Label Image

Figure (Pradaxa 15)

Figure (Pradaxa 15)
An instructional illustration showing a pair of hands cutting open a small packet or sachet with scissors. The image depicts how to properly open the packaging for a product, likely applicable to oral pellets such as Pradaxa (dabigatran etexilate).*
FDA Label Image

Figure (Pradaxa 16)

Figure (Pradaxa 16)
An illustration showing a hand holding a small spoon with pellets, directed toward an open-mouthed baby, indicating the oral administration of pellets to an infant.*
FDA Label Image

Figure (Pradaxa 17)

Figure (Pradaxa 17)
An instructional illustration showing a hand stirring a pellet dosage form in a small cup filled with liquid, demonstrating preparation or administration steps related to oral pellet medication.*
FDA Label Image

Principal Display Panel (20 mg Packet Bag Carton)

Principal Display Panel (20 mg Packet Bag Carton)
Pradaxa (dabigatran etexilate) Oral Pellets 20 mg per packet carton label. The label states the product is provided in an aluminum bag containing 60 packets and includes usage warnings and dispensing instructions. The labeler is Boehringer Ingelheim Pharmaceuticals, Inc.*
FDA Label Image

Principal Display Panel (30 mg Packet Bag Carton)

Principal Display Panel (30 mg Packet Bag Carton)
Pradaxa 30 mg oral pellets packaging label by Boehringer Ingelheim Pharmaceuticals, Inc. The label shows the proprietary name Pradaxa with the generic name dabigatran etexilate. It specifies 30 mg per packet dosage and notes the product is not substitutable on a mg-to-mg basis with other dabigatran etexilate forms. The container includes 1 aluminum bag with 60 packets and directs dispensing with an enclosed medication guide.*
FDA Label Image

Principal Display Panel (40 mg Packet Bag Carton)

Principal Display Panel (40 mg Packet Bag Carton)
Pradaxa oral pellets 40 mg per packet packaging label from Boehringer Ingelheim Pharmaceuticals, Inc. The label indicates 1 aluminum bag contains 60 packets. It states that the pellets are not substitutable on a mg-to-mg basis with other dabigatran etexilate dosage forms and includes usage instructions and dispensing information.*
FDA Label Image

Principal Display Panel (50 mg Packet Bag Carton)

Principal Display Panel (50 mg Packet Bag Carton)
Pradaxa (dabigatran etexilate) Oral Pellets 50 mg per packet packaging label. The label indicates the product is dispensed with an enclosed medication guide and warns that these oral pellets are not substitutable on a mg-to-mg basis with other dabigatran etexilate forms. The package contains 1 aluminum bag with 60 packets and is labeled by Boehringer Ingelheim Pharmaceuticals, Inc.*
FDA Label Image

Principal Display Panel (110 mg Packet Bag Carton)

Principal Display Panel (110 mg Packet Bag Carton)
Pradaxa 110 mg oral pellets packaging label showing the drug name, active ingredient dabigatran etexilate, and dosage form as oral pellets. The label indicates 110 mg per packet strength and notes the package contains 1 aluminum bag with 60 packets. Labeler is Boehringer Ingelheim Pharmaceuticals, Inc. Additional instructions about use and storage are included on the label.*
FDA Label Image

Principal Display Panel (150 mg Packet Bag Carton)

Principal Display Panel (150 mg Packet Bag Carton)
Pradaxa (dabigatran etexilate) Oral Pellets 150 mg per packet packaging label. The label includes a NDC number 0597-0450-16 and states the product contains 1 aluminum bag with 60 packets. The label warns against substituting pellets for other dabigatran etexilate dosage forms and advises discarding unused pellets 6 months after opening. The labeler is Boehringer Ingelheim Pharmaceuticals, Inc.*

* 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.