Source: FDA, National Drug Code (US) | Revision Year: 2020 | Publisher:
PROZAC (fluoxetine capsules, USP) is a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NO•HCl. Its molecular weight is 345.79.
The structural formula is:
Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water.
Each Pulvule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The Pulvules also contain starch, gelatin, silicone, titanium dioxide, iron oxide, and other inactive ingredients. The 10 and 20 mg Pulvules also contain FD&C Blue No. 1, and the 40 mg Pulvule also contains FD&C Blue No. 1 and FD&C Yellow No. 6.
The following products are manufactured by Eli Lilly and Company for Dista Products Company:
Pulvule are available in 10 mg, 20 mg and 40 mg capsule strengths and packages as follows:
|10 mg1||20 mg1||40 mg1|
|Cap Color||Opaque green||Opaque green||Opaque green|
|Body Color||Opaque green||Opaque yellow||Opaque orange|
|Identification||DISTA 3104||DISTA 3105||DISTA 3107|
|Prozac 10 mg||Prozac 20 mg||Prozac 40 mg|
|Bottles of 30||0777-3105-30||0777-3107-30|
|Bottles of 2000||0777-3105-07|
1 Fluoxetine base equivalent.
2 Protect from light.
Marketed by: Lilly USA, LLC Indianapolis, IN 46285, USA
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