FDA.reportPublic FDA data

OLANZAPINE

Product NDC
13668-088
11-digit product format
136680088
Labeler code
13668
Product ID
13668-088_1a64829a-2434-4c8d-8e58-9b28758e4b88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OLANZAPINE
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA091415
Marketing category
ANDA
Marketing start
2011-10-25
Substance
OLANZAPINE
Active strength
10 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091415-001OLANZAPINEOLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-25
A091415-002OLANZAPINEOLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-25
A091415-003OLANZAPINEOLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-25
A091415-004OLANZAPINEOLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-25

Therapeutic equivalence codes#

Application-product, TE code table
Application-productTE code
A091415-001AB
A091415-002AB
A091415-003AB
A091415-004AB

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OLANZAPINEOLANZAPINETorrent Pharmaceuticals Limited2cb1bebe-0ced-46d8-bf21-c28a9acc4a152026-03-02Boxed warning, Warnings, Adverse reactionsExact identifier

Boxed warning cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

boxed warning

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Olanzapine is not approved for the treatment of patients with dementia-related psychosis. ( 5.1 , 8.5 , 17 ) When using olanzapine and fluoxetine in combination, also refer to the Boxed Warning section of the package insert for Symbyax. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Olanzapine is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.5 ), and Patient Counseling Information ( 17 )] . When using olanzapine and fluoxetine in combination, also refer to the Boxed Warning section of the package insert for Symbyax.

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings and cautions

5 WARNINGS AND PRECAUTIONS Elderly Patients with Dementia-Related Psychosis: Increased risk of death and increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack). ( 5.1 ) Suicide: The possibility of a suicide attempt is inherent in schizophrenia and in bipolar I disorder, and close supervision of high-risk patients should accompany drug therapy; when using in combination with fluoxetine, also refer to the Boxed Warning and Warnings and Precautions sections of the package insert for Symbyax.( 5.2 ) Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring. ( 5.3 ) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Discontinue if DRESS is suspected. ( 5.4 ) Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes including hyperglycemia, dyslipidemia, and weight gain. ( 5.5 ) Hyperglycemia and Diabetes Mellitus: In some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients taking olanzapine. Patients taking olanzapine should be monitored for symptoms of hyperglycemia and undergo fasting blood glucose testing at the beginning of, and periodically during, treatment. ( 5.5 ) Dyslipidemia: Undesirable alterations in lipids have been observed. Appropriate clinical monitoring is recommended, including fasting blood lipid testing at the beginning of, and periodically during, treatment. ( 5.5 ) Weight Gain: Potential consequences of weight gain should be considered. Patients should receive regular monitoring of weight. ( 5.5 ) Tardive Dyskinesia: Discontinue if clinically appropriate. ( 5.6 ) Orthostatic Hypotension: Orthostatic hypotension associated with dizziness, tachycardia, bradycardia and, in some patients, syncope, may occur especially during initial dose titration. Use caution in patients with cardiovascular disease, cerebrovascular disease, and those conditions that could affect hemodynamic responses. ( 5.7 ) Leukopenia, Neutropenia, and Agranulocytosis: Has been reported with antipsychotics, including olanzapine. Patients with a history of a clinically significant low white blood cell count (WBC) or drug induced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and discontinuation of olanzapine should be con...

warnings and cautions table

Table 2: Changes in Fasting Glucose Levels from Adult Olanzapine Monotherapy Studies a Not Applicable. Up to 12 weeks exposure At least 48 weeks exposure LaboratoryAnalyte Category Change (at least once) from Baseline Treatment Arm N Patients N PatientsNormal to HighOlanzapine5432.2%34512.8%Fasting(<100 mg/dL to ≥126 mg/dL)Placebo2933.4%NA aNA aGlucoseBorderline to High (≥100 mg/dL and <126 mg/dL Olanzapine17817.4%12726.0%to ≥126 mg/dL)Placebo9611.5%NA aNA a

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

adverse reactions

6 ADVERSE REACTIONS 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 refer to the Adverse Reactions section of the package insert for Symbyax. ( 6 ) To report SUSPECTED ADVERSE REACTIONS , contact Torrent Pharma Inc. at 1-800-912-9561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch When using olanzapine and fluoxetine in combination, also refer to the Adverse Reactions section of the package insert for Symbyax. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect or predict the rates observed in practice. Clinical Trials in Adults The information below for olanzapine is derived from a clinical trial database for olanzapine consisting of 10,504 adult patients with approximately 4,765 patient-years of exposure to olanzapine. This database includes: (1) 2,500 patients who participated in multiple-dose oral olanzapine premarketing trials in schizophrenia and Alzheimer's disease representing approximately 1,122 patient-years of exposure as of February 14, 1995; (2) 182 patients who participated in oral olanzapine premarketing bipolar I disorder (manic or mixed episodes) trials representing approximately 66 patient-years of exposure; (3) 191 patients who participa...

adverse reactions table

Table 9: Common Treatment-Emergent Adverse Reactions Associated with theUse of Oral Olanzapine in 6-Week Trials — SCHIZOPHRENIA a Personality disorder is the COSTART term for designating nonaggressive objectionable behavior. Percentage of Patients Reporting Event Adverse Reaction Olanzapine (N=248) Placebo (N=118)Postural hypotension52Constipation93Weight gain61Dizziness114Personality disorder a84Akathisia51

Additional Listing Data#

Finished product
Yes
Brand name base
OLANZAPINE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLANZAPINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN7U69T4SZR
Rxcui200034, 283639, 312076, 312077, 312078, 312079, 314154, 314155, 351107, 351108

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
42e9462d-db65-453b-8069-8fb2df9182e8Product name120211216
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
12d02c27-e8da-47f1-b815-ccca982731efProduct name920170802
877783eb-030c-6e3f-0979-804cf94d8856Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13668-088-05OLANZAPINE500 in 1 BOTTLETABLET, ORALLY DISINTEGRATING50019
13668-088-30OLANZAPINE30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING3019
13668-088-90OLANZAPINE90 in 1 BOTTLETABLET, ORALLY DISINTEGRATING9019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-088-30EA - Each13668-0888b32e986-34de-4d68-bb23-76f0cb89183112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OLANZAPINEACTIVE INGREDIENTN7U69T4SZROLANZAPINE TABLET OLANZAPINE TABLET, ORALLY DISINTEGRATING [TORRENT PHARMACEUTICALS LIMITED]6
OLANZAPINEACTIVE MOIETYN7U69T4SZROLANZAPINE TABLET OLANZAPINE TABLET, ORALLY DISINTEGRATING [TORRENT PHARMACEUTICALS LIMITED]6
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1OLANZAPINE TABLET OLANZAPINE TABLET, ORALLY DISINTEGRATING [TORRENT PHARMACEUTICALS LIMITED]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOLANZAPINE TABLET OLANZAPINE TABLET, ORALLY DISINTEGRATING [TORRENT PHARMACEUTICALS LIMITED]6
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOLANZAPINE TABLET OLANZAPINE TABLET, ORALLY DISINTEGRATING [TORRENT PHARMACEUTICALS LIMITED]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OLANZAPINE TABLET OLANZAPINE TABLET, ORALLY DISINTEGRATING [TORRENT PHARMACEUTICALS LIMITED]6
MANNITOLINACTIVE INGREDIENT3OWL53L36AOLANZAPINE TABLET OLANZAPINE TABLET, ORALLY DISINTEGRATING [TORRENT PHARMACEUTICALS LIMITED]6
OLANZAPINEACTIVE INGREDIENTN7U69T4SZROLANZAPINE (OLANZAPINE) TABLET, ORALLY DISINTEGRATING [AVPAK]4
OLANZAPINEACTIVE MOIETYN7U69T4SZROLANZAPINE (OLANZAPINE) TABLET, ORALLY DISINTEGRATING [AVPAK]4
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1OLANZAPINE (OLANZAPINE) TABLET, ORALLY DISINTEGRATING [AVPAK]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOLANZAPINE (OLANZAPINE) TABLET, ORALLY DISINTEGRATING [AVPAK]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOLANZAPINE (OLANZAPINE) TABLET, ORALLY DISINTEGRATING [AVPAK]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OLANZAPINE (OLANZAPINE) TABLET, ORALLY DISINTEGRATING [AVPAK]4
MANNITOLINACTIVE INGREDIENT3OWL53L36AOLANZAPINE (OLANZAPINE) TABLET, ORALLY DISINTEGRATING [AVPAK]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-088OLANZAPINE TABLET OLANZAPINE TABLET, ORALLY DISINTEGRATING [TORRENT PHARMACEUTICALS LIMITED]17Current NDC, Legacy NDC, 3 package rows20250305_2cb1bebe-0ced-46d8-bf21-c28a9acc4a15.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312076OLANZapine 10 MG Disintegrating Oral TabletPSN2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
314154OLANZapine 10 MG Oral TabletPSN2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
351107OLANZapine 15 MG Disintegrating Oral TabletPSN2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
312077OLANZapine 15 MG Oral TabletPSN2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
200034OLANZapine 2.5 MG Oral TabletPSN2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
351108OLANZapine 20 MG Disintegrating Oral TabletPSN2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
283639OLANZapine 20 MG Oral TabletPSN2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
314155OLANZapine 5 MG Disintegrating Oral TabletPSN2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
312078OLANZapine 5 MG Oral TabletPSN2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
312079OLANZapine 7.5 MG Oral TabletPSN2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
312076olanzapine 10 MG Disintegrating Oral TabletSCD2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
314154olanzapine 10 MG Oral TabletSCD2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
351107olanzapine 15 MG Disintegrating Oral TabletSCD2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
312077olanzapine 15 MG Oral TabletSCD2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
200034olanzapine 2.5 MG Oral TabletSCD2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
351108olanzapine 20 MG Disintegrating Oral TabletSCD2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
283639olanzapine 20 MG Oral TabletSCD2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
314155olanzapine 5 MG Disintegrating Oral TabletSCD2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
312078olanzapine 5 MG Oral TabletSCD2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
312079olanzapine 7.5 MG Oral TabletSCD2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
13668-088-0513668008805500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (13668-088-05) 2011-10-250000-00-00NoNoCurrent
13668-088-301366800883030 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (13668-088-30) 2011-10-250000-00-00NoNoCurrent
13668-088-7413668008874100 TABLET, ORALLY DISINTEGRATING in 1 CARTON (13668-088-74) 2011-10-250000-00-00NoNoCurrent
13668-088-901366800889090 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (13668-088-90) 2011-10-250000-00-00NoNoCurrent