Source: FDA, National Drug Code (US) Revision Year: 2019
Edluar contains zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Edluar is available in 5 mg and 10 mg strength tablets for sublingual administration.
Chemically, zolpidem tartrate is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure:
Zolpidem tartrate is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88.
Each Edluar tablet includes the following inactive ingredients: mannitol, colloidal silicon dioxide, silicified microcrystalline cellulose, croscarmellose sodium, saccharin sodium, and magnesium stearate.
| Dosage Forms and Strengths |
|---|
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Edluar is available in 5 mg and 10 mg strength tablets for sublingual administration. Tablets are not scored. Edluar 5 mg sublingual tablets are round white, flat-faced, bevel-edged, with debossed V on one side. Edluar 10 mg sublingual tablets are round white, flat-faced, bevel-edged, with debossed X on one side. |
| How Supplied |
|---|
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Edluar is supplied as sublingual tablets in two dosage strengths: Tablets are not scored. Edluar 5 mg sublingual tablets are round white tablets, flat-faced, bevel-edged with debossed V on one side and supplied as: NDC Number Size: 0037-6050-30 blister pack of 30 The blister packs consist of aluminum/aluminum Child Resistant Control (CRC) blisters. Edluar 10 mg sublingual tablets are round white tablets, flat-faced, bevel-edged with debossed X on one side and supplied as: NDC Number Size: 0037-6010-30 blister pack of 30 The blister packs consist of aluminum/aluminum Child Resistant Control (CRC) blisters. |
| Drug | Countries | |
|---|---|---|
| EDLUAR | Austria, Estonia, France, Ireland, Romania, United States |
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