Ztalmy Suspension
Product Images NDC 81583-100

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Ztalmy (NDC 81583-100). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Immedica Pharma Us 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 (Ztalmy 01)

Chemical structure diagram of ganaxolone, the active ingredient in ZTALMY oral suspension 50 mg/mL by Immedica Pharma US Inc. The diagram shows a multi-ring steroid-like structure with specific carbon atoms and functional groups outlined.*

FDA Label Image

Figure 1 (Ztalmy 02)

A bar chart comparing the proportion of patients by percentage reduction from baseline in major motor seizure frequency for ZTALMY (ganaxolone) oral suspension 50 mg/mL versus placebo groups. The x-axis shows seizure reduction ranges, and the y-axis shows patient proportions as percentages, with separate bars for ZTALMY and placebo in each range.*

FDA Label Image

Image (Ztalmy 03)

ZTALMY ganaxolone oral suspension 50 mg/mL in a clear plastic bottle with a white cap. The front label shows the product name, generic name, dosage form, strength, and instructions for oral administration. The label also includes storage instructions and disposal guidance, with the labeler Immedica Pharma US Inc and NDC 81583-100.*

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Image (Ztalmy 04)

Illustration showing a hand holding a small bottle with a white cap, accompanied by the text 'Shake Well,' indicating the suspension should be shaken before use.*

FDA Label Image

Image (Ztalmy 05)

An instructional illustration showing a person holding a bottle with one hand and twisting the cap open with the other hand, demonstrating how to open the suspension bottle. This image relates to ZTALMY (ganaxolone) oral suspension.*

FDA Label Image

Image (Ztalmy 06)

The image shows the top portion of a bottle with a white child-resistant cap. This bottle is consistent with oral suspension packaging, but no visible labeling or text is shown on the bottle itself to confirm the product identity.*

FDA Label Image

Image (Ztalmy 07)

An instructional diagram showing two hands holding a small bottle. One hand grips the bottle while the other hand is positioned above the cap, indicating the action of opening or pressing the cap downward. The bottle appears to be the ZTALMY 50 mg/mL oral suspension.*

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Image (Ztalmy 08)

Illustration showing two steps for measuring and preparing a dose of oral suspension medication. The first panel depicts a hand holding a bottle with a syringe inserted for drawing medication. The second panel shows the hand removing the syringe with measured suspension from the bottle.*

FDA Label Image

Image (Ztalmy 09)

An instructional illustration of a clear oral dosing syringe with volume markings, used for measuring liquid medication. The syringe includes a black stopper and a finger flange near the bottom for handling. It is likely intended for administering ZTALMY (ganaxolone) 50 mg/mL oral suspension.*

FDA Label Image

Image (Ztalmy 10)

Illustration showing two steps of preparing oral suspension medication. The first image depicts a hand pouring liquid from a bottle into an oral dosing syringe. The second image shows the syringe being capped and held upright, likely for administration or storage.*

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Image (Ztalmy 11)

An instructional illustration showing hands preparing oral suspension medication using a syringe and bottle. One hand holds a bottle while the other pulls the syringe plunger upward, indicating the withdrawal of medication from the bottle.*

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Image (Ztalmy 12)

An instructional illustration depicting the administration of an oral suspension using a syringe. It shows a hand holding a syringe directed into an open mouth, indicating the route of administration for the medication.*

FDA Label Image

Image (Ztalmy 13)

An instructional illustration showing two hands opening a bottle, demonstrating how to twist off the cap from an oral suspension bottle. This image is related to the proper handling of the medication bottle.*

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Principal Display Panel (50 mg/mL Bottle Label)

Label for ZTALMY (ganaxolone) oral suspension 50 mg/mL by Immedica Pharma US Inc. The 110 mL bottle label includes storage instructions, recommended dosage referral, administration advice, marketing information from Marinus Pharmaceuticals, and spaces for date of first opening, lot number, and expiration date. Barcode and prescription-only designation are also visible.*

FDA Label Image

Principal Display Panel (50 mg/mL Bottle Carton)

Packaging label for Ztalmy (ganaxolone) oral suspension 50 mg/mL by Immedica Pharma US Inc. The label indicates a 110 mL bottle for oral administration only, with instructions to keep out of reach of children, store at 15-30°C, and discard 30 days after opening. It includes warnings about tamper-evident seals and pharmacist dispensing information. The label also lists storage instructions, patient warnings, and packaging contents including prescribing information and medication guide.*

FDA Label Image

Principal Display Panel (50 mg/mL Bottle Carton)

ZTALMY (ganaxolone) oral suspension 50 mg/mL carton label for human prescription drug by Immedica Pharma US Inc. The label includes dosing instructions, storage information, and packaging details. It states the package contains five bottles each with 110 mL of ganaxolone suspension. Barcode and lot/expiration placeholders are present.*

* 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.