SYMBYAX Capsule Ref.[50742] Active ingredients: Fluoxetine Olanzapine

Source: FDA, National Drug Code (US)  Revision Year: 2021 

Product description

SYMBYAX (olanzapine and fluoxetine HCl capsules) combines an atypical antipsychotic and a selective serotonin reuptake inhibitor, olanzapine (the active ingredient in Zyprexa, and Zyprexa Zydis) and fluoxetine hydrochloride (the active ingredient in Prozac and Sarafem).

Olanzapine belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44.

Fluoxetine hydrochloride is a selective serotonin reuptake inhibitor (SSRI). The chemical designation is (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride. The molecular formula is C17H18F3NO•HCl, which corresponds to a molecular weight of 345.79.

The chemical structures are:

Olanzapine is a yellow crystalline solid, which is practically insoluble in water.

Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water.

SYMBYAX capsules are available for oral administration in the following strength combinations:

 3 mg/25 mg 6 mg/25 mg
olanzapine 3 6
fluoxetine base
equivalent
25 25

Each capsule also contains pregelatinized starch, gelatin, dimethicone, titanium dioxide, sodium lauryl sulfate, edible black ink, red iron oxide, yellow iron oxide, and/or black iron oxide.

Dosage Forms and Strengths

Capsules (mg olanzapine/mg equivalent fluoxetine):

  • 3 mg/25 mg
  • 6 mg/25 mg
How Supplied

SYMBYAX capsules are supplied in 3/25 mg, 6/25 mg (mg olanzapine/mg equivalent fluoxetinea) strengths.

SYMBYAXCAPSULE STRENGTH
 3 mg/25 mg 6 mg/25 mg
Color Peach &
Light Yellow
Mustard Yellow
& Light Yellow
Capsule No. PU3230 PU3231
Identification Lilly 3230 Lilly 3231
 3/25 6/25
NDC Codes
Bottles 30 0002-3230-30 0002-3231-30

a Fluoxetine base equivalent.

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

Drugs

Drug Countries
SYMBYAX Mexico, United States

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