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NDC 42291-0654-30 Olanzapine and Fluoxetine 50; 6 mg/1; mg/1 Details
Olanzapine and Fluoxetine 50; 6 mg/1; mg/1
Olanzapine and Fluoxetine is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by AvKARE. The primary component is FLUOXETINE HYDROCHLORIDE; OLANZAPINE.
MedlinePlus Drug Summary
Fluoxetine is used to treat depression, obsessive-compulsive disorder (bothersome thoughts that won't go away and the need to perform certain actions over and over), some eating disorders, and panic attacks (sudden, unexpected attacks of extreme fear and worry about these attacks). Fluoxetine is also used to relieve the symptoms of premenstrual dysphoric disorder, including mood swings, irritability, bloating, and breast tenderness. It is also used along with olanzapine (Zyprexa) to treat depression that did not respond to other medications and episodes of depression in people with bipolar I disorder (manic-depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods). Fluoxetine is in a class of medications called selective serotonin reuptake inhibitors (SSRIs). It works by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance.
Related Packages: 42291-0654-30Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fluoxetine
Olanzapine is used to treat the symptoms of schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions) in adults and teenagers 13 years of age and older. It is also used to treat bipolar disorder (manic depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods) in adults and teenagers 13 years of age and older. Olanzapine is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.
Related Packages: 42291-0654-30Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Olanzapine
Product Information
| NDC | 42291-0654 |
|---|---|
| Product ID | 42291-654_0e9921e5-8eea-5fe0-e063-6294a90a8765 |
| Associated GPIs | 62995002500125 |
| GCN Sequence Number | 053401 |
| GCN Sequence Number Description | olanzapine/fluoxetine HCl CAPSULE 6MG-50MG ORAL |
| HIC3 | H7Z |
| HIC3 Description | SSRI-ANTIPSYCH, ATYPICAL,DOPAMINE,SEROTONIN ANTAG |
| GCN | 20869 |
| HICL Sequence Number | 025800 |
| HICL Sequence Number Description | OLANZAPINE/FLUOXETINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Olanzapine and Fluoxetine |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Olanzapine and Fluoxetine |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 50; 6 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
| Labeler Name | AvKARE |
| Pharmaceutical Class | Atypical Antipsychotic [EPC], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA077528 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 42291-0654-30 (42291065430)
| NDC Package Code | 42291-654-30 |
|---|---|
| Billing NDC | 42291065430 |
| Package | 30 CAPSULE in 1 BOTTLE (42291-654-30) |
| Marketing Start Date | 2014-01-21 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |