Source: FDA, National Drug Code (US) Revision Year: 2020
ZOLOFT contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)4(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride.
The empirical formula C17H17NCl2∙HCl is represented by the following structural formula:
Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol.
ZOLOFT tablets for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, D & C Yellow #10 aluminum lake (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Red #40 aluminum lake (in 25 mg tablet), FD & C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, synthetic yellow iron oxide (in 100 mg tablet), and titanium dioxide.
ZOLOFT oral solution is available in a multidose 60 mL bottle. Each mL of solution contains 22.4 mg sertraline hydrochloride equivalent to 20 mg of sertraline. The solution contains the following inactive ingredients: glycerin, alcohol (12%), menthol, butylated hydroxytoluene (BHT). The oral solution must be diluted prior to administration [See Dosage and Administration (2.7)]. The dispenser contains dry natural rubber.
| Dosage Forms and Strengths |
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25 mg tablets: light green film-coated, engraved on one side with “ZOLOFT” and on the other side scored and engraved with “25 mg”. 50 mg tablets: light blue film-coated, engraved on one side with “ZOLOFT” and on the other side scored and engraved with “50 mg”. 100 mg tablets: light yellow film-coated, engraved on one side with “ZOLOFT” and on the other side scored and engraved with “100 mg”. Oral solution: a clear, colorless solution with a menthol scent containing sertraline hydrochloride equivalent to 20 mg of sertraline per mL and 12% alcohol. It is supplied as a 60 mL bottle with an accompanying calibrated dropper that has 25 mg and 50 mg graduation marks. |
| How Supplied | ||||||||||||||||||||||||||
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ZOLOFT 25 mg tablets: light green, film-coated, capsular-shaped tablets engraved on one side with “ZOLOFT” and on the other side scored and engraved with "25 mg"
ZOLOFT 50 mg tablets: light blue, film-coated, capsular-shaped tablets engraved on one side with “ZOLOFT” and on the other side scored and engraved with "50 mg"
ZOLOFT 100 mg tablets: light yellow, film-coated, capsular-shaped, tablets engraved on one side with “ZOLOFT” and on the other side scored and engraved with "100 mg"
ZOLOFT oral solution: clear, colorless solution with a menthol scent containing sertraline hydrochloride equivalent to 20 mg of sertraline per mL and 12% alcohol
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| Drug | Countries | |
|---|---|---|
| ZOLOFT | Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Finland, France, Hong Kong, Croatia, Italy, Lithuania, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, United States, South Africa |
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