Opfolda Capsule
Product Images NDC 71904-300

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Opfolda (NDC 71904-300). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Amicus Therapeutics Us, Llc, 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

Figure 1 (Opfolda 01)

An instructional timeline diagram showing fasting and treatment steps related to OPFOLDA. The timeline spans 0 to 7 hours, indicating to begin fasting at 0 hours, take OPFOLDA capsules at 2 hours, then start a typical 4-hour Pombiliti infusion at 3 hours, with fasting stopping at 5 hours and completing the Pombiliti infusion at 7 hours.*

FDA Label Image

Chemical Structure (Opfolda 02)

Chemical structure of miglustat, the active ingredient in OPFOLDA 65 mg oral capsules. The diagram shows the molecular structure including hydroxyl groups and a methyl group, depicting the arrangement of atoms in the miglustat molecule.*

FDA Label Image

Figure 2 (Opfolda 03)

A line graph comparing FVC mean change from baseline (± standard error) over 52 weeks between OPFOLDA in combination with Pombiliti and a comparator. Data points are shown at 0, 12, 26, 38, and 52 weeks with corresponding subject numbers listed below for each group.*

FDA Label Image

Figure 3 (Opfolda 04)

A line graph showing the 6-minute walk distance (6MWD) mean change from baseline over 52 weeks. It compares OPFOLDA in combination with Pombiliti and a comparator group, with data points at multiple time intervals (0, 12, 26, 38, and 52 weeks). The graph includes error bars indicating standard error (SE) for each data point.*

FDA Label Image

4 Count Bottle Label (Opfolda 05)

OPFOLDA 65 mg capsules label showing the active ingredient miglustat, manufactured by Amicus Therapeutics US, LLC. The label includes the NDC 71904-300-01, storage instructions, recommended dosage info, and a warning that the product must be used with POMBLITI. The package contains 4 capsules and is marked Rx only. The label also displays a barcode, lot number, expiration date, and a capsule image with imprint AT2221.*

FDA Label Image

24 Count Bottle Label (Opfolda 06)

OPFOLDA 65 mg capsules packaging label showing a single capsule in white and gray with imprint AT2221. Contains miglustat as the active ingredient. The label includes dosage strength, manufacturer Amicus Therapeutics US, LLC, storage instructions, and a 24-capsule package count. The label also displays lot number, expiration date, serial number, barcode, and GTIN.*

FDA Label Image

100 Count Bottle Label (Opfolda 07)

Label for OPFOLDA (miglustat) capsules, 65 mg, by Amicus Therapeutics US, LLC. The label displays product name, active ingredient, strength, a small image of a white/gray capsule with imprint AT2221, NDC 71904-300-03, package size of 100 capsules, storage instructions, and barcode.*

* 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.