Gomekli Capsule
Product Images NDC 82448-260

Product Visual Gallery

This gallery contains 28 technical images submitted to the FDA as part of the official labeling for Gomekli (NDC 82448-260). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Springworks Therapeutics, 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

Gomekli Capsules And Tablets For Oral Suspension Contain Mirdametinib, A Kinase Inhibitor. Mirdametinib Is Chemically Known As (r)-n-(2,3-dihydroxypropoxy)-3,4-difluoro-2-((2- Fluoro-4-iodophenyl)amino) Benzamide. The Molecular Formula Is C16h14 F3in2o4 And The Molecular Weight Is 482.20 G/mol. The Structural Formula For Mirdametinib Is: (Mirdametinib Tablet 01)

Chemical structure diagram of mirdametinib, the active ingredient in Gomekli. The structure displays molecular bonds and functional groups characteristic of this compound.*

FDA Label Image

Step 2 (Mirdametinib Tablet 02)

An illustration of a transparent cup partially filled with liquid, designed to accompany instructions for oral suspension of a medication.*

FDA Label Image

Step 3 (Mirdametinib Tablet 03)

An instructional illustration showing a hand holding tablets dispensed from a bottle. The image demonstrates the action of pouring tablets from an oral medication bottle into the palm of a hand.*

FDA Label Image

Step 4 (Mirdametinib Tablet 04)

An instructional illustration showing a hand pressing down a tablet into a small cup, likely depicting tablet preparation for suspension. The image emphasizes the oral dosage form, tablet for suspension, of the drug mirdametinib (Gomekli).*

FDA Label Image

Step 5 (Mirdametinib Tablet 05)

Illustration showing a hand holding a cup or container and stirring its contents with a stirring utensil, indicated by a rotational arrow. This instructional image likely demonstrates how to prepare or mix a drug suspension.*

FDA Label Image

2-4 Min (Mirdametinib Tablet 06)

An illustration resembling a clock face depicting a time range of 2 to 4 minutes, likely indicating a timing instruction related to the drug.*

FDA Label Image

Step A1 (Mirdametinib Tablet 07)

An illustration showing a person drinking from a small container, demonstrating the method of taking an oral tablet formulated for suspension, consistent with the administration route of Gomekli (mirdametinib) tablets for suspension.*

FDA Label Image

Step A2 (Mirdametinib Tablet 08)

An illustration showing a clear cup containing a gray liquid partially filled to about one-third of its height. The image likely demonstrates the suspension preparation for Gomekli (mirdametinib) tablets for suspension, oral use.*

FDA Label Image

Step A3 (Mirdametinib Tablet 09)

Instructional illustration showing a hand holding a small cup, with an arrow indicating a swirling or mixing motion inside the cup. The image likely depicts preparation or mixing of an oral suspension for a tablet product.*

FDA Label Image

Step A4 (Mirdametinib Tablet 0a)

An illustration depicting a person drinking a liquid from a cup or glass, suggesting the administration of an oral suspension medication.*

FDA Label Image

Step A5 (Mirdametinib Tablet 0b)

An instructional illustration showing a hand holding a tablet and inserting it into a measuring container or a glass, likely demonstrating how to prepare mirdametinib tablets for suspension. The image focuses on the oral dosage form "tablet for suspension."*

FDA Label Image

Step B1 (Mirdametinib Tablet 0c)

An instructional diagram showing a hand holding a small cup with granules or powder, with a syringe being pulled upward from the cup, indicating preparation or measurement for an oral suspension dose.*

FDA Label Image

Step B2 (Mirdametinib Tablet 0d)

An instructional illustration showing a person administering medication using an oral syringe aimed at their mouth, demonstrating the correct method for oral liquid dosing or suspension.*

FDA Label Image

Step B3 (Mirdametinib Tablet 0e)

An instructional diagram showing a person administering a medication by oral syringe. The syringe is positioned at the person's mouth, with an arrow indicating the direction of administration, demonstrating how to give oral suspension effectively.*

FDA Label Image

Step B4 (Mirdametinib Tablet 0f)

An illustration of a small clear cup containing a liquid, showing a partial fill level. The image likely represents the tablet for suspension form of the drug Gomekli (mirdametinib) to be suspended in a liquid before oral administration.*

FDA Label Image

Step B5 (Mirdametinib Tablet 10)

An instructional illustration showing a hand stirring or mixing the contents of a small cup or container with a circular motion indicated by an arrow. This figure likely demonstrates the proper way to prepare or suspend the medication before administration.*

FDA Label Image

Step B6 (Mirdametinib Tablet 11)

Illustration showing a hand holding a syringe-like device with an arrow pointing upwards, indicating the action of pulling or lifting, likely related to the preparation or administration of oral suspension medication.*

FDA Label Image

Step B7 (Mirdametinib Tablet 12)

An instructional illustration showing a hand holding a syringe being used to add water or liquid to a tablet in a small container or cup, likely demonstrating the preparation of Gomekli (mirdametinib) tablets for oral suspension.*

FDA Label Image

Principal Display Panelndc 82448-134-84gomeklitm (mirdametinib) Tablets For Oral Suspension1 mgper Tablet84 Tablets (Mirdametinib Tablet 13)

The packaging label for GOMEKLI (mirdametinib) Tablets for Oral Suspension, 1 mg strength, shows a box containing 84 tablets. The label includes the proprietary name GOMEKLI with the generic name mirdametinib, dosage form as tablets for oral suspension, and strength of 1 mg per tablet. It displays the manufacturer SpringWorks Therapeutics, Inc., and the NDC 82448-134-84. The label also includes storage instructions and contact information for the manufacturer.*

FDA Label Image

Principal Display Panelndc 82448-134-84gomeklitm (mirdametinib) Tablets For Oral Suspension1 mgper Tablet84 Tablets (Mirdametinib Tablet 14)

Gomekli 1 mg tablets for oral suspension packaging label. Each tablet contains 1 mg mirdametinib. The label shows 84 tablets per bottle. Manufactured by SpringWorks Therapeutics, Inc. Recommended storage is 20°C to 25°C with allowed excursions and protection from light. The label includes dosing instructions to swallow tablets whole or disperse in water and standard barcode and regulatory text.*

FDA Label Image

Principal Display Panelndc 82448-134-42gomeklitm (mirdametinib) Tablets For Oral Suspension1 mgper Tablet42 Tablets (Mirdametinib Tablet 15)

Packaging label for Gomekli 1 mg tablets for oral suspension containing mirdametinib. The label includes product branding, dosage strength, and manufacturer information for SpringWorks Therapeutics, Inc. It specifies 42 tablets per package and provides storage and dosage instructions along with regulatory information and barcodes.*

FDA Label Image

Principal Display Panelndc 82448-134-42gomeklitm (mirdametinib) Tablets For Oral Suspension1 mgper Tablet42 Tablets (Mirdametinib Tablet 16)

The packaging label for Gomekli (mirdametinib) 1 mg tablets for oral suspension by SpringWorks Therapeutics, Inc. It shows a 42-tablet count with usage instructions emphasizing swallowing tablets whole or dispersing in water before administration. The label includes storage conditions, manufacturer details in Stamford, CT, and barcodes.*

FDA Label Image

Principal Display Panelndc 82448-130-42gomeklitm (mirdametinib) Capsules1 mgper Capsules42 Capsules (Mirdametinib Tablet 17)

Gomekli 1 mg capsules packaging label showing the brand and generic name mirdametinib. The label indicates 1 mg strength per capsule with 42 capsules per package. It includes dosage information, storage instructions, and manufacturer details for SpringWorks Therapeutics, Inc. The label is designed for oral capsules and displays multiple barcodes.*

FDA Label Image

Principal Display Panelndc 82448-130-42gomeklitm (mirdametinib) Capsules1 mgper Capsules42 Capsules (Mirdametinib Tablet 18)

Gomekli 1 mg capsules packaging label for mirdametinib oral capsules by SpringWorks Therapeutics, Inc. The label shows the product name, strength, capsule count of 42, NDC 82448-130-42, barcode, storage instructions, and manufacturer contact information. It emphasizes swallowing the capsules whole and keeping out of reach of children.*

FDA Label Image

Principal Display Panelndc 82448-260-42gomeklitm (mirdametinib) Capsules2 mgper Capsules42 Capsules (Mirdametinib Tablet 19)

Packaging label for Gomekli 2 mg capsules, containing mirdametinib as the active ingredient. The product is manufactured by SpringWorks Therapeutics, Inc. and contains 42 capsules. The label includes storage instructions, dosage instructions to swallow capsules whole, and manufacturer contact information. The label prominently displays the brand name, generic name, strength, and capsule dosage form.*

FDA Label Image

Principal Display Panelndc 82448-260-42gomeklitm (mirdametinib) Capsules2 mgper Capsules42 Capsules (Mirdametinib Tablet 1a)

The packaging label for Gomekli (mirdametinib) Capsules, 2 mg strength per capsule. The label indicates the product is available in a bottle containing 42 capsules. The label includes dosage instructions, storage information, and manufacturer details for SpringWorks Therapeutics, Inc. The design features the brand and generic names prominently with the strength in a blue box and a teal lower band containing the SpringWorks logo.*

FDA Label Image

Principal Display Panelndc 82448-260-84gomeklitm (mirdametinib) Capsules2 mgper Capsules84 Capsules (Mirdametinib Tablet 1b)

The packaging label for Gomekli (mirdametinib) 2 mg capsules indicates each capsule contains 2 mg of active ingredient. The label shows the product is supplied in a package of 84 capsules, intended for oral use. It includes dosage instructions to swallow capsules whole, storage conditions, and manufacturer details for SpringWorks Therapeutics, Inc.*

FDA Label Image

Principal Display Panelndc 82448-260-84gomeklitm (mirdametinib) Capsules2 mgper Capsules84 Capsules (Mirdametinib Tablet 1c)

Packaging label for Gomekli (mirdametinib) Capsules 2 mg by SpringWorks Therapeutics, Inc. The label shows that there are 84 capsules per package. Instructions indicate capsules should be swallowed whole and each contains 2 mg of mirdametinib. Storage conditions and contact information for the manufacturer are also included.*

* 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.