Miplyffa Capsule
Product Images NDC 72542-124

Product Visual Gallery

This gallery contains 17 technical images submitted to the FDA as part of the official labeling for Miplyffa (NDC 72542-124). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Acer 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

Chemical Structure (Mip00 0001 01)

Chemical structure of arimoclomol citrate, showing its molecular arrangement including a chlorinated aromatic ring, ether linkage, hydroxyl group, piperidine ring, and citrate moieties.*

FDA Label Image

Figure 1 (Mip00 0001 02)

A line graph comparing mean change from baseline in R4DNPCSS over 12 months between MIPLYFFA with miglustat and placebo with miglustat. The x-axis shows time since baseline in months (0, 3, 6, 9, 12), and the y-axis indicates mean change from baseline. The graph shows that placebo with miglustat increases over time, while MIPLYFFA with miglustat remains near baseline, with data points and error bars visible for both groups.*

FDA Label Image

Figure A (Mip00 0001 03)

An instructional illustration showing hands assembling or preparing a device or container by snapping or clicking the parts together, indicated by an arrow between the components. No text or branding is visible.*

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Figure B (Mip00 0001 04)

An instructional illustration showing a hand opening a capsule and pouring its contents into a small cup marked with a 15 mL measurement. The image visually demonstrates how to empty the capsule contents for administration.*

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Figure C (Mip00 0001 05)

An instructional illustration showing a hand dipping a capsule into a glass of water. A 15-second timer icon is displayed, indicating the capsule should be immersed in water for 15 seconds.*

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Figure D (Mip00 0001 06)

An instructional illustration showing a hand holding a glass and a person drinking from it, depicting oral ingestion of a medication or liquid.*

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Figure E (Mip00 0001 07)

An instructional illustration showing a hand holding a device above a cup marked with a 20 mL measurement. The device appears to be pouring or dispensing liquid into the cup, demonstrating how to measure or administer a liquid dose.*

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Figure F (Mip00 0001 08)

Illustration showing two hands demonstrating how to open a child-resistant cap on a medication bottle by pressing down and turning the cap simultaneously.*

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Figure G (Mip00 0001 09)

An instructional illustration showing a hand pouring small capsules or granules from a spoon into a 20 mL measuring cup filled with liquid, demonstrating the process of mixing medication for oral administration.*

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Figure H (Mip00 0001 10)

An instructional illustration showing a hand dipping a single capsule into a glass of liquid with a timer icon indicating a 15-second interval. This likely demonstrates a step related to preparing the MIPLYFFA oral capsule for administration.*

FDA Label Image

Figure I (Mip00 0001 11)

An instructional illustration showing a hand inserting a capsule into a syringe-like device, with an arrow indicating downward movement, and another hand holding the device. Below, a container is depicted, suggesting the capsule contents might be released into it.*

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Figure J (Mip00 0001 12)

An instructional illustration showing a syringe attached to a tube with an arrow indicating the plunger being pushed. The diagram likely demonstrates a method of administration or fluid transfer involving the syringe and tubing.*

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Figure K (Mip00 0001 13)

An illustration showing a syringe with a plunger, labeled with a 5 mL volume mark, connected to a tube or catheter, indicating a liquid measurement or administration setup.*

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Principal Display Panel – 47 mg Carton Label (Mip00 0001 14)

MIPLYFFA 47 mg (arimoclomol) capsules packaging label showing NDC 72542-147-01 from Acer Therapeutics Inc. The label states 90 capsules for oral use and emphasizes prescription-only status. Additional text includes storage instructions, dosage reference, and manufacturing information by Zevra Therapeutics, Inc., USA.*

FDA Label Image

Principal Display Panel – 62 mg Carton Label (Mip00 0001 15)

Packaging label for MIPLYFFA 62 mg capsules, containing arimoclomol. The label indicates the product is for oral use with 90 capsules in the package. The manufacturer listed is Zevra Therapeutics, Inc. The label includes storage instructions and a child-resistant package notice.*

FDA Label Image

Principal Display Panel – 93 mg Carton Label (Mip00 0001 16)

MIPLYFFA 93 mg capsules packaging label showing arimoclomol as the active ingredient. The label indicates 90 oral capsules per container. The product is labeled for Rx only and manufactured for Zevra Therapeutics, Inc. Storage instructions and dosage recommendations are printed on the package, which is child-resistant.*

FDA Label Image

Principal Display Panel – 124 mg Carton Label (Mip00 0001 17)

MIPLYFFA 124 mg (arimoclomol) capsules packaging label showing a 90-capsule bottle for oral use. The label includes the product name, strength, and the labeler Acer Therapeutics Inc. Storage instructions note controlled room temperature and protection from light. The label also states the package is child-resistant and includes barcode and manufacturer details for Zevra Therapeutics, Inc. in Celebration, FL, USA.*

* 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.