Diazepam Gel
Product Images NDC 43386-280

Product Visual Gallery

This gallery contains 18 technical images submitted to the FDA as part of the official labeling for Diazepam (NDC 43386-280). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Lupin Pharmaceuticals,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.

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Diazepam (C0373097 D1ea 4e58 Ab36 A28e7e65136e 01)

Chemical structure of Diazepam, showing its molecular components including a chlorophenyl group, a diazepine ring, and other functional groups characteristic of the diazepam molecule.*

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Figure-1 (C0373097 D1ea 4e58 Ab36 A28e7e65136e 02)

A line graph comparing mean plasma concentrations (ng/mL) of diazepam and desmethyldiazepam over time (hours) following administration of 7.5 mg intravenous (IV) diazepam and 15 mg diazepam rectal gel. The graph shows higher initial plasma levels with IV administration and a prolonged concentration after rectal gel dosing, with concentrations measured up to 240 hours.*

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Image (C0373097 D1ea 4e58 Ab36 A28e7e65136e 03)

A horizontal bar chart comparing patient response percentages for diazepam rectal gel versus placebo. It categorizes patient outcomes into 'Better,' 'Same,' and 'Worse' for each treatment, showing a higher percentage of patients reporting improvement with diazepam rectal gel compared to placebo.*

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Image (C0373097 D1ea 4e58 Ab36 A28e7e65136e 04)

A Kaplan-Meier curve chart depicting the probability of no seizure over a 24-hour period. The graph compares Diazepam Rectal Gel, showing higher probability of no seizure, to placebo, which shows a lower probability over time.*

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Image (C0373097 D1ea 4e58 Ab36 A28e7e65136e 05)

A Kaplan-Meier survival plot showing the probability of no seizure over a 12-hour period. The graph compares two groups: one treated with diazepam rectal gel and the other with placebo, with time in hours on the x-axis and probability of no seizure on the y-axis.*

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10 mg (C0373097 D1ea 4e58 Ab36 A28e7e65136e 06)

Diazepam Rectal Gel 10 mg Rectal Delivery System label from Lupin Pharmaceuticals,Inc. The label includes pharmacist instructions emphasizing proper dose collar setting on syringes with available doses of 5 mg, 7.5 mg, and 10 mg. It also shows warnings, barcode, and detailed pharmacist instructions for choosing, locking, and discarding collars on pre-filled, adjustable dose syringes designed for rectal delivery.*

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20mg (C0373097 D1ea 4e58 Ab36 A28e7e65136e 07)

Diazepam Rectal Gel 20 mg Rectal Delivery System label by Lupin Pharmaceuticals, Inc. This label includes pharmacist instructions with dosage collar color codes for 12.5 mg, 15 mg, 17.5 mg, and 20 mg doses, steps to lock the collar on the syringe, and discard used collars. It emphasizes setting the syringe dose prior to dispensing and proper use of dose locking collars.*

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Image (C0373097 D1ea 4e58 Ab36 A28e7e65136e 08)

Illustration of a Diazepam rectal gel delivery system showing the dose collar and green ready sticker. The device is labeled as Diazepam Rectal Gel 10 mg with instructions to confirm the visibility of the dose collar and green ready sticker before use.*

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Image (C0373097 D1ea 4e58 Ab36 A28e7e65136e 09)

This text panel provides contact information for more information and support related to diazepam rectal gel, including a phone number and additional resources from the Epilepsy Foundation with both a phone number and website address.*

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Image (C0373097 D1ea 4e58 Ab36 A28e7e65136e 10)

A section of a drug facts or instructions panel for Diazepam Rectal Gel, showing tables to record details of seizures before and after use. Each table includes columns for time, seizure type, and number of seizures, intended for patient or caregiver documentation to inform the doctor.*

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Image (C0373097 D1ea 4e58 Ab36 A28e7e65136e 11)

A text panel providing a log format for recording seizure information related to Diazepam Rectal Gel use. It includes sections to note the date, time, seizure type, and number of seizures before and after administration of the gel, intended for communicating important details to the doctor.*

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Image (C0373097 D1ea 4e58 Ab36 A28e7e65136e 12)

Illustrated administration instructions for Diazepam Rectal Gel showing a person lying on their side for safety, the gel medicine and lubricating jelly, a syringe with a cap plug, and the removal of the syringe cap plug prior to use. The title indicates these are steps for how to administer and dispose of the rectal gel delivery system.*

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Image (C0373097 D1ea 4e58 Ab36 A28e7e65136e 13)

Instructional illustrations showing steps for administering Diazepam rectal gel: lubricating the rectal tip with lubricating jelly, turning the person on their side facing the caregiver, bending the upper leg forward to expose the rectum, and separating the buttocks to further expose the rectum.*

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Image (C0373097 D1ea 4e58 Ab36 A28e7e65136e 14)

An instructional diagram showing steps 9 to 12 for administering Diazepam gel rectally. The images depict gently inserting the syringe tip into the rectum, slowly pushing the plunger over a count of three, slowly removing the syringe while counting to three, and holding buttocks together to prevent leakage.*

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Image (C0373097 D1ea 4e58 Ab36 A28e7e65136e 15)

An instructional illustration showing a person lying on their side with a watch on a nearby hand, indicating to keep the person on their side facing the caregiver after administering Diazepam rectal gel. Text instructs to note the time given and continue to observe the person.*

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Image (C0373097 D1ea 4e58 Ab36 A28e7e65136e 16)

An instructional diagram showing disposal steps for Diazepam rectal gel in a prefilled syringe. It illustrates pulling out the plunger, sliding off the dosing collar, pointing the tip over a sink or toilet, pushing the plunger to expel gel, rinsing the sink or flushing the toilet, and discarding used materials. Emergency contact information is also included.*

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10mg (C0373097 D1ea 4e58 Ab36 A28e7e65136e 17)

Diazepam Rectal Gel 10 mg Rectal Delivery System label by Lupin Pharmaceuticals, Inc. The label includes pharmacist warnings about setting syringe dose and instructions to place the correct dosing collar. It shows available doses (5 mg, 7.5 mg, and 10 mg) and contains pharmacist instructions for choosing, locking, and discarding collars on pre-filled adjustable dose syringes for rectal delivery. Includes barcode and requirement that product is Rx only.*

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20mg (C0373097 D1ea 4e58 Ab36 A28e7e65136e 18)

Label for Diazepam Rectal Gel 20 mg Rectal Delivery System by Lupin Pharmaceuticals, Inc. This packaging includes pharmacist instructions emphasizing dose setting, collar locking on syringes, and correct dispensing procedures. Available doses are 12.5 mg, 15 mg, 17.5 mg, and 20 mg with color-coded collars shown. Instructions include choosing, locking, labeling the collar, and discarding used collars and cards. Label contains warnings for pharmacists and caregivers regarding proper use and dispensing.*

* 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.