Diazepam Gel
Product Images NDC 43386-280

Product Visual Gallery

This gallery contains 19 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.

FDA Label Image

Diazepam (Fdfd69c8 D9ae 4e4d 8927 7221f9e5f604 01)

Chemical structure of Diazepam, showing its molecular framework including a benzodiazepine core with a chlorine-substituted phenyl ring, a methyl group attached to the nitrogen atom, and a keto group on the diazepine ring.*

FDA Label Image

Figure-1 (Fdfd69c8 D9ae 4e4d 8927 7221f9e5f604 02)

A line graph depicting the mean plasma concentration (ng/mL) of Diazepam and its metabolite Desmethyldiazepam over time (hours) after administration. The graph compares Diazepam levels after 7.5 mg intravenous (IV) dose and 15 mg rectal gel dose, along with corresponding Desmethyldiazepam levels, showing concentration changes through 8 hours and an extended time frame up to 240 hours.*

FDA Label Image

Image (Fdfd69c8 D9ae 4e4d 8927 7221f9e5f604 03)

A horizontal bar chart comparing patient responses to diazepam rectal gel versus placebo. The chart categorizes patient percentages reporting 'Better,' 'Same,' or 'Worse' outcomes. Diazepam gel shows higher percentages of 'Better' responses and lower 'Same' or 'Worse' compared to placebo across the patient groups.*

FDA Label Image

Image (Fdfd69c8 D9ae 4e4d 8927 7221f9e5f604 04)

A line graph depicting the probability of no seizures over 24 hours comparing Diazepam Rectal Gel to a placebo. The y-axis represents the probability of no seizure, decreasing from 1 to 0, while the x-axis shows time in hours from 0 to 24. The Diazepam Rectal Gel maintains a higher probability of no seizure compared to placebo throughout the observed period.*

FDA Label Image

Image (Fdfd69c8 D9ae 4e4d 8927 7221f9e5f604 05)

A Kaplan-Meier survival curve comparing the probability of no seizure over 12 hours between Diazepam rectal gel and placebo groups. The graph shows higher seizure-free probability in the Diazepam group versus placebo throughout the time period.*

FDA Label Image

10 mg (Fdfd69c8 D9ae 4e4d 8927 7221f9e5f604 06)

Diazepam Rectal Gel 10 mg Rectal Delivery System packaging label from Lupin Pharmaceuticals,Inc. The label includes dosage information, pharmacy instructions to set the syringe dose prior to dispensing, and details on available doses (5 mg, 7.5 mg, and 10 mg). It also contains pharmacist instructions for using the adjustable dose syringes with locking collars for accurate dosing, proper disposal guidance, and a contact number for questions.*

FDA Label Image

20mg (Fdfd69c8 D9ae 4e4d 8927 7221f9e5f604 07)

Diazepam Rectal Gel 20 mg Rectal Delivery System pharmacist instructions and warnings label. The top panel highlights pharmacist attention regarding syringe dose setting and dosing collar use. The bottom panel provides step-by-step instructions for choosing the correct dose collar, locking the collar on the syringe, placing a ready sticker on the plunger head, and discarding used materials. The label is from Lupin Pharmaceuticals and includes a contact number for questions.*

FDA Label Image

Image (91b10d2a 111a 4f2b 8b9a D9c5d4a783f5 203 1)

Diazepam Rectal Gel 10 mg per 2 g single-use prefilled syringe by Lupin Pharmaceuticals, Inc. The carton features bold text showing the brand and generic name, dosage strength, and dosage form. The package is primarily white with black and dark text designed for human prescription use.*

FDA Label Image

Image (Fdfd69c8 D9ae 4e4d 8927 7221f9e5f604 08)

An instructional illustration of Diazepam Rectal Gel 10 mg dosage form showing the rectal delivery system. The diagram highlights the dose collar and a green ready sticker on the syringe-like applicator to confirm correct dosing and readiness for administration.*

FDA Label Image

Image (Fdfd69c8 D9ae 4e4d 8927 7221f9e5f604 09)

A text panel providing contact information for more information and support about diazepam rectal gel. It includes a phone number for direct inquiries and additional resources, such as the Epilepsy Foundation contact details and website.*

FDA Label Image

Image (Fdfd69c8 D9ae 4e4d 8927 7221f9e5f604 10)

A medication guide section instructing patients to record information about seizures before and after using Diazepam Rectal Gel, including date, time, seizure type, and number of seizures. The text is in English and formatted into two boxed areas for easy documentation.*

FDA Label Image

Image (Fdfd69c8 D9ae 4e4d 8927 7221f9e5f604 11)

A text panel titled 'Important things to tell the doctor' with two data input tables. The first table is for recording seizure details before using Diazepam Rectal Gel, including date, time, seizure type, and number of seizures. The second table records seizure details after using the gel, including time, seizure type, and number of seizures.*

FDA Label Image

Image (Fdfd69c8 D9ae 4e4d 8927 7221f9e5f604 12)

Instructional illustrations for administering Diazepam Rectal Gel. Step 1 shows a person lying on their side for safety. Step 2 depicts obtaining the medicine and a lubricating jelly tube. Step 3 shows holding the syringe with the cap plug labeled. Step 4 demonstrates removing the cap plug from the syringe, including a close-up of the action.*

FDA Label Image

Image (Fdfd69c8 D9ae 4e4d 8927 7221f9e5f604 13)

Step-by-step instructional illustrations for administering Diazepam rectal gel. The images show lubricating the rectal tip with jelly, turning the person on their side to face the caregiver, bending the upper leg forward to expose the rectum, and separating the buttocks for rectal access.*

FDA Label Image

Image (Fdfd69c8 D9ae 4e4d 8927 7221f9e5f604 14)

An instructional illustration showing steps 9 to 12 for rectal administration of Diazepam gel. The images depict gently inserting the syringe tip into the rectum, slowly pushing the plunger while counting to three, removing the syringe after counting to three, and holding the buttocks together while counting to three to prevent leakage.*

FDA Label Image

Image (Fdfd69c8 D9ae 4e4d 8927 7221f9e5f604 15)

Instructional illustration showing a person lying on their side with another person's hand checking the time on a wristwatch. The image advises to keep the person on their side facing you after administering Diazepam rectal gel, note the time given, and continue to observe.*

FDA Label Image

Image (Fdfd69c8 D9ae 4e4d 8927 7221f9e5f604 16)

Instructional diagram for the disposal of Diazepam rectal gel syringe from Lupin Pharmaceuticals. It shows step-by-step disposal: pulling out the plunger, sliding off the dosing collar, pointing the tip over a sink or toilet, pushing the plunger to eject remaining gel, and rinsing the sink or flushing the toilet. Additional guidance advises discarding all used materials safely and avoiding reuse. Emergency contact information and situations for calling help are also included.*

FDA Label Image

10mg (Fdfd69c8 D9ae 4e4d 8927 7221f9e5f604 17)

Packaging label for Diazepam Rectal Gel 10 mg Rectal Delivery System by Lupin Pharmaceuticals, Inc. The label includes pharmacist instructions emphasizing syringe dose setting prior to dispensing and use of a locking collar on the syringe. The package contains two pre-filled, adjustable dose syringes for rectal delivery, available in doses of 5 mg, 7.5 mg, and 10 mg, with instructions on how to select, lock, and use the dosing collars before administration.*

FDA Label Image

20mg (Fdfd69c8 D9ae 4e4d 8927 7221f9e5f604 18)

Instructional diagram for Diazepam Rectal Gel 20 mg Rectal Delivery System, showing pharmacist steps: selecting a dosage collar (12.5 mg, 15 mg, 17.5 mg, 20 mg), locking the collar on the syringe with a click, placing a ready sticker on the plunger head, and discarding other collars and this card. Contains warnings and guidance for correct dose collar placement before 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.