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NDC 60505-3275-08 Olanzapine 5 mg/1 Details
Olanzapine 5 mg/1
Olanzapine is a ORAL TABLET, ORALLY DISINTEGRATING in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Apotex Corp.. The primary component is OLANZAPINE.
MedlinePlus Drug Summary
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: 60505-3275-08Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Olanzapine
Product Information
| NDC | 60505-3275 |
|---|---|
| Product ID | 60505-3275_f0e96ab3-d3a5-4061-74a8-d4eb8b9ec393 |
| Associated GPIs | 59157060007210 |
| GCN Sequence Number | 045190 |
| GCN Sequence Number Description | olanzapine TAB RAPDIS 5 MG ORAL |
| HIC3 | H7T |
| HIC3 Description | ANTIPSYCHOTIC,ATYPICAL,DOPAMINE,SEROTONIN ANTAGNST |
| GCN | 92007 |
| HICL Sequence Number | 011814 |
| HICL Sequence Number Description | OLANZAPINE |
| Brand/Generic | Generic |
| Proprietary Name | Olanzapine |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Olanzapine |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, ORALLY DISINTEGRATING |
| Route | ORAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/1 |
| Substance Name | OLANZAPINE |
| Labeler Name | Apotex Corp. |
| Pharmaceutical Class | Atypical Antipsychotic [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA091265 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 60505-3275-08 (60505327508)
| NDC Package Code | 60505-3275-8 |
|---|---|
| Billing NDC | 60505327508 |
| Package | 1000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (60505-3275-8) |
| Marketing Start Date | 2011-10-24 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |