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NDC 55150-0308-01 OLANZAPINE 10 mg/1 Details
OLANZAPINE 10 mg/1
OLANZAPINE is a INTRAMUSCULAR INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Eugia US LLC. The primary component is OLANZAPINE.
MedlinePlus Drug Summary
Olanzapine extended-release injection is used to treat schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions). Olanzapine injection is used to treat episodes of agitation in people who have schizophrenia or in people who have bipolar I disorder (manic depressive disorder; a disease that causes episodes of depression, episodes of severe mania, and other abnormal moods) and are experiencing an episode of mania (abnormally excited or irritated mood). 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: 55150-0308-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Olanzapine Injection
Product Information
| NDC | 55150-0308 |
|---|---|
| Product ID | 55150-308_bf04f518-1842-4b07-8c54-95a725f88837 |
| Associated GPIs | 59157060002120 |
| GCN Sequence Number | 050386 |
| GCN Sequence Number Description | olanzapine VIAL 10 MG INTRAMUSC |
| HIC3 | H7T |
| HIC3 Description | ANTIPSYCHOTIC,ATYPICAL,DOPAMINE,SEROTONIN ANTAGNST |
| GCN | 17407 |
| 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 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route | INTRAMUSCULAR |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/1 |
| Substance Name | OLANZAPINE |
| Labeler Name | Eugia US LLC |
| Pharmaceutical Class | Atypical Antipsychotic [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA210968 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 55150-0308-01 (55150030801)
| NDC Package Code | 55150-308-01 |
|---|---|
| Billing NDC | 55150030801 |
| Package | 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-308-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
| Marketing Start Date | 2020-10-22 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |