Source: FDA, National Drug Code (US) Revision Year: 2020
AMBIEN contains zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. AMBIEN is available in 5 mg and 10 mg strength tablets for oral administration.
Chemically, zolpidem 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 AMBIEN tablet includes the following inactive ingredients: hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. The 5 mg tablet also contains FD&C Red No. 40, iron oxide colorant, and polysorbate 80.
| Dosage Forms and Strengths |
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AMBIEN is available in 5 mg and 10 mg strength tablets for oral administration. Tablets are not scored. AMBIEN 5 mg tablets are capsule-shaped, pink, film coated, with AMB 5 debossed on one side and 5401 on the other. AMBIEN 10 mg tablets are capsule-shaped, white, film coated, with AMB 10 debossed on one side and 5421 on the other. |
| How Supplied | ||||||||
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AMBIEN 5 mg tablets are capsule-shaped, pink, film coated, with AMB 5 debossed on one side and 5401 on the other and supplied as:
AMBIEN 10 mg tablets are capsule-shaped, white, film coated, with AMB 10 debossed on one side and 5421 on the other and supplied as:
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| Drug | Countries | |
|---|---|---|
| AMBIEN | Israel, United States |
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