DIASTAT Gel Ref.[10827] Active ingredients: Diazepam

Source: FDA, National Drug Code (US)  Revision Year: 2021 

Product description

Diazepam rectal gel rectal delivery system is a non-sterile diazepam gel provided in a prefilled, unit-dose, rectal delivery system. Diazepam rectal gel contains 5 mg/mL diazepam, benzoic acid, benzyl alcohol (1.5%), ethyl alcohol (10%), hydroxypropyl methylcellulose, propylene glycol, purified water, and sodium benzoate. Diazepam rectal gel is clear to slightly yellow and has a pH between 6.5-7.2.

Diazepam, the active ingredient of diazepam rectal gel, is a benzodiazepine anticonvulsant with the chemical name 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. The structural formula is as follows:

How Supplied

Diazepam rectal gel rectal delivery system is a non-sterile, prefilled, unit dose, rectal delivery system. The rectal delivery system includes a plastic applicator with a flexible, molded tip available in two lengths, designated for convenience as 10 mg Delivery System and 20 mg Delivery System. The available doses from 20 mg delivery system are 12.5 mg, 15 mg, 17.5 mg and 20 mg. The available doses from 10 mg delivery system are 5 mg, 7.5 mg and 10 mg. The diazepam rectal gel delivery system is available in the following three presentations:

DIASTAT Rectal Tip Size NDC
2.5 mg Twin Pack 4.4 cm 66490-650-20
DIASTAT ACUDIAL Rectal Tip Size NDC
10 mg DeliverySystem Twin Pack 4.4 cm 0187-0658-20
20 mg DeliverySystem Twin Pack 6.0 cm 0187-0659-20

Each Twin Pack contains two diazepam rectal gel delivery systems, two packets of lubricating jelly, and administration and disposal Instructions available on the bottom of the package. DIASTAT ACUDIAL is also packed with Instructions for Caregivers upon receipt from pharmacy.

Manufactured for: Bausch Health US, LLC. Bridgewater, NJ 08807 USA

Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215 USA

Drugs

Drug Countries
DIASTAT Canada, United States

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