Fycompa Tablet
Product Images NDC 69616-278

Product Visual Gallery

This gallery contains 32 technical images submitted to the FDA as part of the official labeling for Fycompa (NDC 69616-278). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Catalyst 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

Image Description (0.5 mg mL Oral Suspension Bottle Label)

Label for Fycompa (perampanel) oral suspension 0.5 mg/mL, 340 mL bottle. The label includes directions for shaking before use, storage instructions, and a note that it is prescription only. Distributed by Catalyst Pharmaceuticals, Inc. and manufactured by Eisai Inc., made in Japan.*

FDA Label Image

Image Description (0.5 mg mL Oral Suspension Carton Label)

Packaging label for Fycompa (perampanel) oral suspension 0.5 mg/mL in a 340 mL bottle. The label includes directions for use, tamper-evident label placement, and storage instructions. The labeler is Catalyst Pharmaceuticals, Inc. A barcode and space for lot, expiration, and serial numbers are shown.*

FDA Label Image

Image Description (10mg Label 30 Ct Italy)

The image shows the carton label for Fycompa (perampanel) tablets, 10 mg strength, oral dosage form. The label indicates a package size of 30 tablets. It includes storage instructions at 25°C (77°F) with permissible excursions, prescription-only status, and cautions for pharmacists to dispense the medication guide. Manufactured by Eisai Inc. for Catalyst Pharmaceuticals, Inc., and distributed by Catalyst Pharmaceuticals in Coral Gables, FL. The label features a barcode and states the product is made in Italy.*

FDA Label Image

Image Description (10mg Label 30 Ct Japan)

Fycompa 10 mg tablets packaging label showing the product name, active ingredient perampanel, strength of 10 mg, and quantity of 30 tablets. The label indicates prescription use only (Rx only) and includes storage instructions at 25°C (77°F) with permissible excursions. It lists Catalyst Pharmaceuticals, Inc. as the distributor, with manufacturing by Eisai Inc. in Japan. A barcode and a pharmacist attention notice to dispense the accompanying medication guide are also visible.*

FDA Label Image

Image Description (12mg Label 30 Ct Italy)

Packaging label for Fycompa 12 mg tablets, an oral prescription drug containing perampanel. The label indicates a 30-tablet count and notes storage instructions at 25°C with permitted excursions. It also includes pharmacy dispensing information. The product is manufactured by Eisai Inc. for Catalyst Pharmaceuticals, Inc.*

FDA Label Image

Image Description (12mg Label 30 Ct Japan)

The image shows a Fycompa 12 mg tablet carton label for oral use, containing 30 tablets. The label includes the proprietary name Fycompa and generic name perampanel. It states storage instructions at 25°C (77°F) with permitted excursions, and notes the product is prescription-only. Manufactured by Eisai Inc. for Catalyst Pharmaceuticals, Inc., and distributed by Catalyst Pharmaceuticals, Inc. in Coral Gables, FL. The label also has a barcode and pharmacist dispensing instructions.*

FDA Label Image

Image Description (2 mg Fycompa Inner Sample Kit)

Fycompa (perampanel) 2 mg tablets sample kit carton label. The label states the package contains fourteen 2 mg tablets and instructions to take one tablet orally once daily at bedtime for two weeks. It includes storage information and the labeler Catalyst Pharmaceuticals, Inc. is implied by product data but not visually shown.*

FDA Label Image

Image Description (2 mg Sample Kit Japan)

Fycompa (perampanel) tablets 2 mg sample kit packaging label from Catalyst Pharmaceuticals, Inc. The label includes dosage instructions to push tablets through the card from the inside, a warning to keep out of reach of children, and notes that the package contains fourteen 2 mg tablets. It is marked as a professional sample and for prescription use only.*

FDA Label Image

Image Description (2mg Sample Kit Italy)

Packaging label for Fycompa (perampanel) tablets, 2 mg strength, presented as a 2 Week Sample Kit containing fourteen 2 mg tablets. The label includes instructions to open the card and push tablets through the card from the inside. It cautions to keep out of reach of children and notes this is a professional sample, not for sale. Catalyst Pharmaceuticals, Inc. is identified as the manufacturer and distributor.*

FDA Label Image

Image Description (2mg Label 30 Ct Italy)

Label for Fycompa 2 mg tablets (perampanel) by Catalyst Pharmaceuticals, Inc. The label states oral tablets, Rx only, with storage instructions at 25°C (77°F) with specified excursions. Manufactured by Eisai Inc. and distributed by Catalyst Pharmaceuticals in Coral Gables, FL. Package contains 30 tablets and is made in Italy.*

FDA Label Image

Image Description (2mg Label 30 Ct Japan)

Label for Fycompa (perampanel) 2 mg oral tablets, packaged as 30 tablets. The label includes storage instructions, NDC number 69616-272-30, and directs pharmacists to dispense the accompanying Medication Guide. Manufactured by Eisai Inc. for Catalyst Pharmaceuticals, Inc., Coral Gables, FL, and made in Japan.*

FDA Label Image

Image Description (4mg Label 30 Ct Italy)

Fycompa 4 mg tablets label for oral use, distributed by Catalyst Pharmaceuticals, Inc. The label includes storage instructions, NDC 69616-274-30, quantity of 30 tablets, and legal and manufacturing details. The design features the product name prominently with strength in a red oval, along with a pharmacist warning to dispense the accompanying Medication Guide.*

FDA Label Image

Image Description (4mg Label 30 Ct Japan)

The image shows the label for Fycompa tablets, 4 mg strength, by Catalyst Pharmaceuticals, Inc. The label includes the proprietary name Fycompa, the generic name perampanel, and indicates the dosage form as tablets. It states storage instructions at 25°C with permitted excursions, contains an NDC code 69616-274-30, and notes the package contains 30 tablets. Additional labeling includes pharmacist dispensing instructions and manufacturer information indicating the product is made in Japan.*

FDA Label Image

Image Description (6mg Label 30 Ct Italy)

Packaging label for Fycompa (perampanel) tablets, 6 mg strength, oral dosage form. The label indicates a package of 30 tablets, with storage instructions at 25°C and regulatory information including NDC 69616-276-30. The labeler is Catalyst Pharmaceuticals, Inc., and it mentions manufacturing by Eisai Inc. The label includes a pharmacist dispensing note to provide the medication guide to patients.*

FDA Label Image

Image Description (6mg Label 30 Ct Japan)

Label for Fycompa tablets containing 6 mg of perampanel, an oral prescription drug by Catalyst Pharmaceuticals, Inc. The label includes storage instructions at 25°C (77°F), a barcode, NDC 69616-276-30, and warnings to pharmacists to dispense the Medication Guide with the product. The label states the product is manufactured by Elsai Inc. in Japan and distributed by Catalyst Pharmaceuticals, Coral Gables, FL.*

FDA Label Image

Image Description (8 mg Label 30 Ct Japan)

Label for Fycompa (perampanel) tablets, 8 mg strength, in a package of 30 tablets. The label indicates it is for prescription use only, manufactured by Eisai Inc. for Catalyst Pharmaceuticals, Inc., and distributed by Catalyst Pharmaceuticals, Inc. Storage instructions specify 25°C (77°F) with permitted excursions. The label includes a warning to pharmacists to dispense the accompanying Medication Guide to each patient.*

FDA Label Image

Image Description (8mg Label 30 Ct Italy)

Label for Fycompa (perampanel) tablets, 8 mg strength, oral dosage form. The label includes storage instructions, NDC 69616-278-30, and indicates a package size of 30 tablets. It notes Rx only and labels Catalyst Pharmaceuticals, Inc. as distributor, with manufacturing by Elasil Inc. in Italy.*

FDA Label Image

Image Description (Fycompa 01)

Chemical structure of perampanel with associated hydration state indicated as 3/4 H2O.*

FDA Label Image

Image Description (Fycompa 02)

A bar graph comparing median percentage reduction in seizure frequency from baseline across three clinical studies of Fycompa (perampanel) versus placebo. Each study shows seizure reduction percentages for placebo and varying Fycompa doses, with Fycompa bars generally higher, indicating greater seizure reduction. Sample sizes for each group are noted. Statistical significance versus placebo is indicated by asterisks.*

FDA Label Image

Image Description (Fycompa 03)

A bar chart comparing the proportion of patients (%) across different response categories (Worse, 0 to <25, 25 to <50, 50 to <75, 75 to 100) for Placebo and Fycompa (perampanel) oral tablet dosages of 4 mg/day, 8 mg/day, and 12 mg/day.*

FDA Label Image

Image Description (Fycompa 04)

A bar chart comparing the proportion of patients in placebo versus Fycompa treatment groups across five outcome categories: Worse, 0 to <25%, 25 to <50%, 50 to <75%, and 75 to 100%. The chart shows percentages of patients on the vertical axis with group sizes of 81 each. Fycompa treatment has a notably higher proportion of patients in the 75 to 100% category compared to placebo.*

FDA Label Image

Image Description (Fycompa 05)

Illustration showing components of an oral dosing system for Fycompa liquid, including a bottle with cap, a box, a bottle adapter, and two syringes. A close-up details the syringe parts: tip, barrel with dosage indicators from 0 to 20 mL, and plunger, for accurate measurement of liquid medication volume.*

FDA Label Image

Image Description (Fycompa 06)

An instructional line drawing showing a hand holding a bottle with a screw cap, demonstrating the motion of shaking the bottle well. The text "shake well" with an arrow indicates the shaking action.*

FDA Label Image

Image Description (Fycompa 07)

A simple black and white line drawing labeled 'bottle adapter' depicting a cylindrical component with multiple ridges, likely intended to fit onto a bottle as an adapter or connector piece.*

FDA Label Image

Image Description (Fycompa 08)

A black-and-white instructional illustration showing a hand gripping the neck of a bottle and another hand poised to place or remove a cap, with a downward arrow indicating the direction of the action. The image likely instructs on opening or closing the bottle.*

FDA Label Image

Image Description (Fycompa 09)

An instructional diagram showing a 20 mL oral dosing syringe used to measure liquid medication. The syringe consists of a tip, a barrel with measurement markings in milliliters from 1 to 20, and a plunger at the bottom. A magnified inset highlights the dosage indicator markings on the barrel for precise volume measurement.*

FDA Label Image

Image Description (Fycompa 10)

An instructional illustration showing a hand holding a dosing syringe above a bottle, indicating the syringe being inserted into the bottle opening for oral liquid medication administration.*

FDA Label Image

Image Description (Fycompa 11)

An instructional illustration showing a hand holding a bottle inverted while drawing liquid medication into a syringe held by the other hand, indicating how to measure an oral medication dose accurately.*

FDA Label Image

Image Description (Fycompa 12)

An instructional diagram showing a hand using a syringe to withdraw liquid from a bottle. The other hand is holding the bottle steady. The image includes an upward-pointing arrow indicating the direction for pulling the syringe up to draw the medication.*

FDA Label Image

Image Description (Fycompa 13)

Black and white instructional illustration showing a person administering an oral dose of medication using a syringe. The syringe is held by a hand and placed near the person's open mouth, indicating oral administration technique for a liquid medication.*

FDA Label Image

Image Description (Fycompa 14)

An instructional illustration showing two-step use of an oral syringe. The first panel depicts drawing liquid medicine from a cup by pulling back the plunger. The second panel shows administering the dose by pushing the plunger to release the liquid. The syringe has clear measurement markings.*

FDA Label Image

Image Description (Fycompa 15)

An instructional line drawing showing a hand grasping the cap of a bottle, demonstrating how to open it. No specific product labeling or text is visible on the bottle or cap.*

* 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.