PROZAC Capsule Ref.[10615] Active ingredients: Fluoxetine

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

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.

Dosage Forms and Strengths
  • 10 mg Pulvule is an opaque green cap and opaque green body, imprinted with DISTA 3104 on the cap and Prozac 10 mg on the body
  • 20 mg Pulvule is an opaque green cap and opaque yellow body, imprinted with DISTA 3105 on the cap and Prozac 20 mg on the body
  • 40 mg Pulvule is an opaque green cap and opaque orange body, imprinted with DISTA 3107 on the cap and Prozac 40 mg on the body
How Supplied

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:

 Pulvule Strength
10 mg1 20 mg1 40 mg1
Pulvule No.2 PU3104 PU3105 PU3107
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
NDC Codes:    
Bottles of 30 0777-3105-30 0777-3107-30
Bottles 100 0777-3104-02 0777-3105-02  
Bottles of 2000  0777-3105-07  

1 Fluoxetine base equivalent.
2 Protect from light.

Marketed by: Lilly USA, LLC Indianapolis, IN 46285, USA

Drugs

Drug Countries
PROZAC Australia, Brazil, Canada, Ecuador, Estonia, Spain, France, Hong Kong, Ireland, Israel, Italy, Malta, Mexico, Netherlands, New Zealand, Romania, Singapore, Turkey, United Kingdom, United States, South Africa
 
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