Fintepla Solution
Product Images NDC 43376-322

Product Visual Gallery

This gallery contains 30 technical images submitted to the FDA as part of the official labeling for Fintepla (NDC 43376-322). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Ucb, 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 (Fintepla 01)

Chemical structure of fenfluramine hydrochloride, the active ingredient in Fintepla oral solution 2.2 mg/mL by UCB, Inc. The diagram shows the molecule's arrangement including a trifluoromethyl-substituted aromatic ring and an amine group with hydrochloride salt.*

FDA Label Image

Principal Display Panel (Fintepla 02)

A bar chart depicting the proportion of patients (%) experiencing different ranges of percentage reduction from baseline in convulsive seizure frequency. The chart compares three groups: Placebo (N=39), Fintepla 0.2 mg/kg/day (N=38), and Fintepla 0.7 mg/kg/day (N=40). Proportions are shown across five seizure reduction categories: <0%, 0 to <25%, 25 to <50%, 50 to <75%, and 75 to 100%, with higher efficacy at the 0.7 mg/kg/day dose.*

FDA Label Image

Principal Display Panel (Fintepla 03)

A bar chart comparing the proportion of patients with different percentage reductions from baseline in convulsive seizure frequency between placebo (N=42) and Fintepla 0.4 mg/kg/day (N=43). The chart shows five categories of percentage reduction, illustrating higher proportions of patients achieving greater seizure reduction with Fintepla compared to placebo.*

FDA Label Image

Principal Display Panel (Fintepla 04)

Two horizontal bar charts comparing the durations in days for placebo and Fintepla (fenfluramine) treatment groups in two separate studies. Study 1 shows three groups: placebo with the shortest duration, Fintepla 0.2 mg/kg/day with a moderate duration, and Fintepla 0.7 mg/kg/day with the longest duration, including p-values indicating statistical significance. Study 2 compares placebo and Fintepla 0.4 mg/kg/day groups, with Fintepla showing a longer duration and a p-value indicating significance.*

FDA Label Image

Principal Display Panel (Fintepla 05)

The image shows packaging for Fintepla Oral Solution, 2.2 mg/mL fenfluramine, featuring one bottle and two oral syringes. The product is labeled for oral administration and manufactured by UCB, Inc. The image displays the bottle and syringes as separate sealed units.*

FDA Label Image

Image (Fintepla 06)

Illustration showing two options for oral syringes used for Fintepla (fenfluramine) oral solution. One option is 2 oral syringes of 3 mL capacity with dose markings in 0.1 mL increments. The other option is 2 oral syringes of 6 mL capacity with dose markings in 0.5 mL increments.*

FDA Label Image

Image (Fintepla 07)

A labeled line drawing of an oral syringe showing its parts: the tip, barrel of the syringe, base of the syringe, and plunger. This illustration helps identify the components of the syringe used for administering liquid medication.*

FDA Label Image

Image (Fintepla 08)

An illustration showing a bottle and a dosing syringe. The bottle is designed for oral solution, likely representing the Fintepla 2.2 mg/mL oral solution packaging. The dosing syringe, positioned next to the bottle, is intended for measuring and administering the oral solution dose.*

FDA Label Image

Image (Fintepla 09)

An instructional diagram showing a hand pressing down and turning the cap of a bottle, demonstrating how to open a child-resistant closure.*

FDA Label Image

Image (Fintepla 10)

Illustration showing a hand holding a bottle of Fintepla oral solution with a labeled adapter at the bottle's opening. The image demonstrates the location and presence of the adapter on the bottle.*

FDA Label Image

Steps 1 And 2 (Fintepla 11)

Illustration of an oral solution dosing device, likely a syringe or dispenser, with a narrow tip and a plunger mechanism at the bottom designed for accurate measurement and administration of liquid medication.*

FDA Label Image

Step 3 (Fintepla 12)

An instructional diagram showing a plunger in an oral syringe labeled 'Plunger is all the way in.' The image highlights proper plunger position for dosing, likely related to Fintepla oral solution use.*

FDA Label Image

Step 4 (Fintepla 13)

An instructional illustration showing a hand inserting a syringe into the neck of a bottle, with an arrow pointing downward indicating the direction of insertion. Another hand is holding the bottle steady.*

FDA Label Image

Step 5 (Fintepla 14)

An instructional diagram showing how to hold a bottle of Fintepla oral solution upside down for dispensing. The image depicts one hand holding the bottle inverted above a measuring syringe held by the other hand, with the instruction 'Turn upside down' indicated prominently.*

FDA Label Image

Step 6 (Fintepla 15)

Illustration showing a hand holding a bottle of oral solution with the bottle inverted, dispensing into a syringe below. The image demonstrates how to draw liquid medication from the bottle into the syringe for oral administration.*

FDA Label Image

Steps 7 And 8 (Fintepla 16)

An instructional illustration showing a 3 mL syringe with dose markings labeled in 0.1 mL increments, highlighting measurements from 0.5 mL to 3 mL. The image focuses on guiding proper dose measurement in the syringe for oral administration.*

FDA Label Image

Step 9 (Fintepla 17)

An instructional illustration showing a 6 mL oral syringe with dose markings in 0.5 mL increments. The image highlights the graduated scale from 1 to 6 mL, demonstrating how doses are measured using the syringe for liquid medication administration.*

FDA Label Image

Step 10 (Fintepla 18)

An instructional illustration showing how to measure a liquid dose with a syringe. It depicts a syringe being filled from a bottle, with an arrow and text indicating to 'Line up end of plunger with dose mark' for accurate dosing.*

FDA Label Image

Image (Fintepla 19)

An instructional illustration showing how to hold a bottle and syringe with the text 'Turn right side up.' The image demonstrates filling a syringe from a bottle, with one hand holding the bottle and the other drawing the liquid into the syringe.*

FDA Label Image

Image (Fintepla 20)

An instructional illustration showing a hand using a syringe to draw liquid medicine from a bottle. The image depicts the upward motion of the plunger being pulled to withdraw the solution into the syringe, with one hand stabilizing the bottle and the other operating the syringe.*

FDA Label Image

Step 11 (Fintepla 21)

Illustration showing a person administering an oral dose of medication using a syringe into the mouth. The image depicts the correct positioning for oral administration of a liquid solution.*

FDA Label Image

Step 12 (Fintepla 22)

An instructional diagram showing a hand tightening a child-resistant cap on a bottle containing oral solution. The image includes an arrow indicating the direction to turn the cap and the text "Close tightly." This likely demonstrates proper bottle closure for a liquid medication.*

FDA Label Image

Steps 13 And 14 (Fintepla 23)

An instructional illustration showing hands rinsing an oral solution dosing syringe under running water from a faucet. The image demonstrates proper cleaning of the syringe used for administering the medication Fintepla (fenfluramine) oral solution.*

FDA Label Image

Steps 15 And 16 (Fintepla 24)

Label for Fintepla (fenfluramine) oral solution, 2.2 mg/mL, prescription medication. The label includes the NDC 43376-322-30 and indicates a 30 mL bottle. It notes storage instructions, dosage equivalency to 2.5 mg/mL hydrochloride salt, and advises dispensing the enclosed Medication Guide. Manufactured by Zogenix Inc., Emeryville, CA.*

FDA Label Image

Step 17 (Fintepla 25)

Fintepla (fenfluramine) oral solution 2.2 mg/mL in a carton label by UCB, Inc. The label shows the product name, strength, and dosage form multiple times, a barcode, NDC 43376-322-30, and storage instructions. It also mentions the bottle size as one 30 mL and includes pharmacist dispensing instructions.*

FDA Label Image

Image (Fintepla 26)

Label for Fintepla (fenfluramine) oral solution 2.2 mg/mL, a prescription drug. The label indicates it is for oral use only, with a content volume of 360 mL. It includes storage instructions, usage directions, and manufacturer information for Zogenix Inc., Emeryville, CA. The label features barcodes and a placeholder for discard and expiration dates.*

FDA Label Image

Principal Display Panel (30 mL Bottle Label)

Fintepla (fenfluramine) 2.2 mg/mL oral solution medication carton label. The label shows dosing instructions referencing prescribing information, storage conditions (68°F to 77°F, no refrigeration or freezing), contents of a 360 mL bottle, and dispensing instructions to pharmacists. Manufactured by Zogenix, Inc., Emeryville, CA.*

FDA Label Image

Principal Display Panel (30 mL Bottle Carton)

A bar chart illustrating the proportion of patients by percentage reduction from baseline in drop seizure frequency, comparing placebo, Fintepla 0.2 mg/kg/day, and Fintepla 0.7 mg/kg/day groups. Categories range from less than 0% to 75-100% reduction, showing variances in patient response across treatment groups.*

FDA Label Image

Principal Display Panel (360 mL Bottle Label)

Fintepla (fenfluramine) oral solution 2.2 mg/mL label showing NDC 43376-322-36. The label includes storage instructions, warnings not to refrigerate or freeze, and a note to discard unused portions after 3 months. Contents volume is 360 mL. Manufactured for UCB, Inc., Smyrna, GA.*

FDA Label Image

Principal Display Panel (360 mL Bottle Carton)

Fintepla (fenfluramine) oral solution 2.2 mg/mL carton label. The label states it is for oral use only and contains one 360 mL bottle. It includes storage instructions to keep at controlled room temperature (68°F to 77°F) and not to refrigerate or freeze. The label also directs pharmacists to dispense the enclosed Medication Guide to each patient. Manufactured for UCB, Inc., Smyrna, GA, product of United Kingdom. NDC 43376-322-36.*

* 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.