Cariprazinedrug info
cariprazine 4.5 MG Oral Capsule [Vraylar]
What it is used for
1. INDICATIONS AND USAGE VRAYLAR ® is indicated for:
Treatment of schizophrenia in adult and pediatric patients 13 years of age and older
Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older
Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients
Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adult patients VRAYLAR is an atypical antipsychotic indicated for: Treatment of schizophrenia in adults and pediatric patients 13 years of age and older Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults and pediatric patients 10 years of age and older Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective December 18, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
11. DESCRIPTION The active ingredient of VRAYLAR is cariprazine, an atypical antipsychotic, in hydrochloride salt form. The chemical name is trans -N-{4-[2-[4-(2,3-dichlorophenyl)piperazine-1-yl]ethyl]cyclohexyl}-N’,N’-dimethylurea hydrochloride; its empirical formula is C 21 H 3 2 Cl 2 N 4 O
HCl and its molecular weight is 463.9 g/mol. The chemical structure is: VRAYLAR capsules are intended for oral administration only. Each hard gelatin capsule contains 0.5, 0.75, 1.5, 3, 4.5, or 6 mg of cariprazine base (equivalent to 0.545 mg, 0.818 mg, 1.635 mg, 3.27 mg, 4.905 mg, or 6.54 mg cariprazine HCl). In addition, capsules include the following inactive ingredients: gelatin, magnesium stearate, pregelatinized starch, shellac, and titanium dioxide. Colorants include black iron oxide (0.5, 0.75, 1.5, 3, and 6 mg), FD&C Blue 1 (0.5, 0.75, 3, 4.5, and 6 mg), FD&C Red 3 (6 mg), FD&C Red 40 (3 and 4.5 mg), or yellow iron oxide (0.5, 3, and 4.5 mg). The chemical structure for VRAYLAR is cariprazine HCl, an atypical antipsychotic. The chemical name is trans-N-{4-[2-[4-(2,3 dichlorophenyl)piperazine-1-yl]ethyl]cyclohexyl}-N’,N’-dimethylurea hydrochloride; its empirical formula is C21H33Cl3N4O and its molecular weight is 463.9 g/mol.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective December 18, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
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