Lisdexamfetamine Dimesylate Capsule
Product Images NDC 0054-0372

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Lisdexamfetamine Dimesylate (NDC 0054-0372). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Hikma Pharmaceuticals Usa 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

Lisdexamfetamine Pan Black.jpg (Image 01)

FDA Label Image

Figure-1.jpg (Image 02)

Figure-1.jpg (Image 02)
This text appears to be about special populations and their characteristics. It mentions gender (male/female), age range (65-74 years and greater than or equal to 75 years), and different levels of renal impairment (mild, moderate, severe, and end stage renal disease). It also mentions PK (possibly referring to pharmacokinetics), fold change, and a confidence interval of 90%. The last line mentions a change relative to reference, but the meaning is unclear due to incomplete text.*
FDA Label Image

Figure-5.jpg (Image 03)

Figure-5.jpg (Image 03)
This text provides information about the proportion of subjects with relapse/treatment failure, represented as a percentage. The data compares a placebo group to a group treated with lisdexamfetamine dimesylate. The time period represented is indicated in days after randomization. The specific values and context surrounding them are not available.*
FDA Label Image

20mg-100tabs.jpg (Image 04)

20mg-100tabs.jpg (Image 04)
The text provided is a description of a medication. Each capsule contains Lisdexametamine dimesylate, equivalent to 16 me, lisdexamfetamine. The dosage information can be found in the package insert. The medication should be stored at a temperature of 20° to 25°C (68°to 77°F), with excursions permitted to 15° to 30°C (59° to 86°F). The medication should be dispensed in a tight, light-resistant container. It is distributed by Hikma Pharmaceuticals USA Inc in Berkeley Heights, NJ. The NDC number is 0054-0370-25 for 100 capsules of Lisdexamfetamine Dimesylate at a strength of 20 mg. The pharmacist should dispense a medication guide to patients.*
FDA Label Image

30mg-100tabs.jpg (Image 05)

FDA Label Image

Figure 4.jpg (Image 06)

FDA Label Image

Image-6.jpg (Image 07)

FDA Label Image

Image-7.jpg (Image 08)

FDA Label Image

40mg-100tabs.jpg (Image 09)

40mg-100tabs.jpg (Image 09)
Each capsule contains 40 mg of Lisdexamfetamine dimesylate, which is equivalent to 231 mg of lisdexamfetamine. Please refer to the package insert for dosage information. Store the capsules at a temperature of 20° to 25°C (68° to 77°F), with excursions permitted to 15° to 30°C (59° to 86°F) as per USP Controlled Room Temperature guidelines. Dispense the capsules in a tightly closed container according to the USP definition. This medication is distributed by Hikma Pharmaceuticals USA Inc. in Berkeley Heights, NJ 07922. The NDC number for this product is 0054-0372-25, and it contains 100 capsules of Lisdexamfetamine Dimesylate. Pharmacists should provide the Medication Guide to patients. This product is only available from Hikma.*
FDA Label Image

50mg-100tabs.jpg (Image 10)

50mg-100tabs.jpg (Image 10)
Each capsule contains 50 mg of Lisdexamfetamine dimesylate, which is equivalent to 289 mg of lisdexamfetamine. Please refer to the package insert for dosage information. The capsules should be stored at a temperature between 20°C to 25°C (68°F to 77°F), with excursions allowed between 15°C to 30°C (59°F to 86°F). The product should be dispensed in a tight, light-resistant container. This medication guide is to be dispensed to patients by a pharmacist. The product is distributed by Hikma Pharmaceuticals USA Inc. with the address in Berkeley Heights, NJ 07922. The NDC number for the product is 0054-0373-25, and it contains 100 capsules of Lisdexamfetamine Dimesylate at a strength of 50 mg per capsule.*
FDA Label Image

60mg-100tabs.jpg (Image 11)

60mg-100tabs.jpg (Image 11)
Each capsule of this medication contains 60 mg of Lisdexamfetamine dimesylate, which is equivalent to 347 mg of lisdexamfetamine. The recommended dosage information can be found in the package insert. The medication should be stored between 20°C to 25°C (68°F to 77°F), with excursions permitted to 16°C to 30°C (59°F to 86°F). It should be dispensed in a tight, light-resistant container. The medication is distributed by Hikma Pharmaceuticals USA Inc. in Berkeley Heights, NJ. The NDC code for this medication is 0054-0374-25 with 100 capsules per package.*
FDA Label Image

70mg-100tabs.jpg (Image 12)

70mg-100tabs.jpg (Image 12)
Each capsule contains Lisdexamfetamine dimesylate 70 mg (equivalent to 40.5 mg lisdexamfetamine). This medication is typically used for the treatment of attention deficit hyperactivity disorder (ADHD). The recommended dosage information can be found in the package insert. It is advised to store the capsules between 20° to 25°C (68° to 77°F), with temperature excursions permitted between 16° to 30°C (59° to 86°F). The medication should be dispensed in a tight, light-resistant container. The capsules are distributed by Hikma Pharmaceuticals USA Inc. and come in a package of 100 capsules.*
FDA Label Image

Figure-8.jpg (Image 13)

FDA Label Image

Figure-2.jpg (Image 14)

FDA Label Image

Figure-3.jpg (Image 15)

Figure-3.jpg (Image 15)
The text provided contains a list of drugs and their interaction with certain enzymes. It mentions Guanfacine and Venlafaxine as interacting drugs. It also lists different enzymes (CYP1A2, CYP2D6, CYP2C19, and CYP3A) and their respective substrates. Additionally, it mentions PK (pharmacokinetic) parameters such as Cmax (maximum plasma concentration) and AUC (area under the curve). The text includes information about fold change and 90% CI (confidence interval) as well. The last line states "Change relative to reference" followed by a numerical value of 2.0. Overall, the text seems to provide information about drug interactions and pharmacokinetic parameters.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.