Olanzapine 10 mg/2mL
Olanzapine · INJECTION, POWDER, FOR SOLUTION · XGen Pharmaceuticals DJB, Inc.
Olanzapine is a injection, powder, for solution containing olanzapine at 10 mg/2mL, taken intramuscular. Manufactured by XGen Pharmaceuticals DJB, Inc..
Key Facts
- Brand Name
- Olanzapine
- Generic Name
- Olanzapine
- NDC Code (Product)
39822-1800- Manufacturer
- XGen Pharmaceuticals DJB, Inc.
- Strength
- 10 mg/2mL
- Dosage Form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAMUSCULAR
- Marketing Status
- Application #
- ANDA211072
- Drug Class
- Atypical Antipsychotic [EPC]
- Marketing Start
- 08/28/2025
Recall History
Sun Pharmaceutical Industries, Inc.
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Aurobindo Pharma USA Inc.
Failed Impurities/ Degradation Specifications
Macleods Pharma Usa Inc
cGmp Deviations
Apotex Inc.
Subpotent drug
Eli Lilly & Company
cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product.
Sun Pharmaceutical Industries, Inc.
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Aidapak Services, LLC
Labeling:Label Mixup; OLANZAPINE, Tablet 7.5 mg may be potentially mislabeled as NORTRIPTYLINE HCL, Capsule, 75 mg, NDC 00093081301, Pedigree: AD21790_73, EXP: 5/1/2014.
Torrent Pharma Inc
Defective Container; This action is being taken as a precautionary measure due to the product being re-packaged in the U.S. using a filler material that (removes or blocks) less moisture than what is approved in the application.
Dr. Reddy's Laboratories, Inc.
Failed impurities/degradation specifications: due to out-of-specification result for the Related Substance Compound C (Impurity 6 - N-Oxide at the 18 month stability station.
Apotex Corp.
Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Olanzapine is an atypical antipsychotic indicated: As oral formulation for the: Treatment of schizophrenia. ( 1.1 ) Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1 ) Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia ( 14.1 ). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.1 ) Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. ( 1.2 ) Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. ( 14.2 ) Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder ( 14.2 ). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drug…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Schizophrenia in adults ( 2.1 ) Oral: Start at 5 mg to 10 mg once daily; Target: 10 mg/day within several days Schizophrenia in adolescents ( 2.1 ) Oral: Start at 2.5 mg to 5 mg once daily; Target: 10 mg/day Bipolar I Disorder (manic or mixed episodes) in adults ( 2.2 ) Oral: Start at 10 mg or 15 mg once daily Bipolar I Disorder (manic or mixed episodes) in adolescents ( 2.2 ) Oral: Start at 2.5 mg to 5 mg once daily; Target: 10 mg/day Bipolar I Disorder (manic or mixed episodes) with lithium or valproate in adults ( 2.2 ) Oral: Start at 10 mg once daily Depressive Episodes associated with Bipolar I Disorder in adults ( 2.5 ) Oral in combination with fluoxetine: Start at 5 mg of oral olanzapine and 20 mg of fluoxetine once daily Depressive Episodes associated with Bipolar I Disorder in children and adolescents ( 2.5 ) Oral in combination with fluoxetine: Start at 2.5 mg of oral olanzapine and 20 mg of fluoxetine once daily Treatment Resistant Depression in adults ( 2.6 ) Oral in combination with fluoxetine: Start at 5 mg of oral olanzapine and 20 mg of fluoxetine once daily Lower starting dose recommended in debilitated or pharmacodynamically sensitive p…
Contraindications
4 CONTRAINDICATIONS None with olanzapine monotherapy. When using olanzapine and fluoxetine in combination, also refer to the Contraindications section of the package insert for Symbyax. For specific information about the contraindications of lithium or valproate, refer to the Contraindications section of the package inserts for these other products. None with olanzapine monotherapy.( 4 ) When using olanzapine and fluoxetine in combination, also refer to the Contraindications section of the package insert for Symbyax ® . ( 4 ) When using olanzapine in combination with lithium or valproate, refer to the Contraindications section of the package inserts for those products. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS The risks of using olanzapine in combination with other drugs have not been extensively evaluated in systematic studies. Diazepam: May potentiate orthostatic hypotension. ( 7.1 , 7.2 ) Alcohol: May potentiate orthostatic hypotension. ( 7.1 ) Carbamazepine: Increased clearance of olanzapine. ( 7.1 ) Fluvoxamine: May increase olanzapine levels. ( 7.1 ) Olanzapine and Fluoxetine in Combination: Also refer to the Drug Interactions section of the package insert for Symbyax. ( 7.1 ) CNS Acting Drugs: Caution should be used when taken in combination with other centrally acting drugs and alcohol. ( 7.2 ) Antihypertensive Agents: Enhanced antihypertensive effect. ( 7.2 ) Levodopa and Dopamine Agonists: May antagonize levodopa/dopamine agonists. ( 7.2 ) Other Concomitant Drug Therapy: When using olanzapine in combination with lithium or valproate, refer to the Drug Interactions sections of the package insert for those products. ( 7.2 ) 7.1 Potential for Other Drugs to Affect Olanzapine Diazepam — The co-administration of diazepam with olanzapine potentiated the orthostatic hypotension observed with olanzapine [see Drug Interactions ( 7.2 )] . Cimetidine and Antacids — Sin…
Adverse Reactions
6 ADVERSE REACTIONS When using olanzapine and fluoxetine in combination, also refer to the Adverse Reactions section of the package insert for Symbyax. Most common adverse reactions (≥5% and at least twice that for placebo) associated with: Oral Olanzapine Monotherapy: Schizophrenia (Adults) – postural hypotension, constipation, weight gain, dizziness, personality disorder, akathisia ( 6.1 ) Schizophrenia (Adolescents) – sedation, weight increased, headache, increased appetite, dizziness, abdominal pain, pain in extremity, fatigue, dry mouth ( 6.1 ) Manic or Mixed Episodes, Bipolar I Disorder (Adults) – asthenia, dry mouth, constipation, increased appetite, somnolence, dizziness, tremor ( 6.1 ) Manic or Mixed Episodes, Bipolar I Disorder (Adolescents) – sedation, weight increased, increased appetite, headache, fatigue, dizziness, dry mouth, abdominal pain, pain in extremity ( 6.1 ) Combination of Olanzapine and Lithium or Valproate: Manic or Mixed Episodes, Bipolar I Disorder (Adults) – dry mouth, weight gain, increased appetite, dizziness, back pain, constipation, speech disorder, increased salivation, amnesia, paresthesia ( 6.1 ) Olanzapine and Fluoxetine in Combination: Also ref…
Frequently Asked Questions
What is Olanzapine used for?
Olanzapine contains Olanzapine. It is a injection, powder, for solution taken intramuscular. Consult your doctor for specific uses.
Is Olanzapine a controlled substance?
Olanzapine is not classified as a controlled substance by the DEA.
What is the generic name for Olanzapine?
The generic name for Olanzapine is Olanzapine. There are 3 other brand versions of Olanzapine.
What is the NDC code for Olanzapine 10 mg/2mL?
The NDC (National Drug Code) for Olanzapine 10 mg/2mL is 39822-1800, listed by XGen Pharmaceuticals DJB, Inc..