FDA.reportPublic FDA data

OLANZAPINE - Food and Drug Administration

Manufacturer
Food and Drug Administration
Effective date
2021-12-16
Label type
Indexing - product concept
Version
1
Source
full-release
Hydrated at
2026-06-05 00:19:58

Label at a glance#

ProductOLANZAPINE
Active ingredientOLANZAPINE, SAMIDORPHAN L-MALATE

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
OLANZAPINEN7U69T4SZRACTIB
SAMIDORPHAN L-MALATE0AJQ5N56E0ACTIM
OLANZAPINEN7U69T4SZRACTIB
SAMIDORPHAN L-MALATE0AJQ5N56E0ACTIM
OLANZAPINEN7U69T4SZRACTIB
SAMIDORPHAN L-MALATE0AJQ5N56E0ACTIM
OLANZAPINEN7U69T4SZRACTIB
SAMIDORPHAN L-MALATE0AJQ5N56E0ACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 5 · 95 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OlanzapineOLANZAPINECoupler LLC5af81f87-5582-aa23-e063-6294a90a1ee82026-09-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEHikma Pharmaceuticals USA Inc.63bcfe98-d1fc-4cd7-9212-f59ee4dcc6d12026-08-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEREMEDYREPACK INC.c47ee16f-5a86-49f2-8d85-5f49a6c8d91e2026-08-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINECardinal Health 107, LLC38a89689-efc2-4931-8f65-868dc0248d6a2026-08-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEPreferred Pharmaceuticals Inc.d349d5b7-5658-46d6-9bba-e6f6361cebb92026-08-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEPreferred Pharmaceuticals Inc.5bded04a-d848-4ac6-b7c3-ff9b9fef3d292026-08-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEMajor Pharmaceuticals709d79a1-2742-4629-af43-161be166833a2026-07-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEREMEDYREPACK INC.9eb6b0d1-b301-4847-88f5-f8613d550ecc2026-07-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEPD-Rx Pharmaceuticals, Inc.b6f0b2e2-3cbd-4564-8b3e-f811589af2752026-07-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEREMEDYREPACK INC.3d69af75-7615-4ec2-b7ef-467b2558c5c82026-07-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEDr. Reddy's Laboratories Ltd.a4c525da-c2f6-b804-af49-6012959222542026-07-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEREMEDYREPACK INC.ad350abc-a1fc-4be4-b2be-c629121552a02026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEREMEDYREPACK INC.b513823d-927c-4111-8766-e6c37f84b2212026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEREMEDYREPACK INC.68de2a51-69b2-4d99-be79-36a95a4bc4752026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEMajor Pharmaceuticals0ecbf540-572e-4ca4-b694-18ca1cd1c1942026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEREMEDYREPACK INC.1705bab2-a2f8-4534-b1fc-eb309cd2696b2026-07-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINECamber Pharmaceuticals, Inc.c1387008-6dc4-4f1e-ae29-fa7a0f0be6842026-07-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEREMEDYREPACK INC.8e5ef52d-315b-4055-9e52-403e6f896f242026-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
olanzapineOLANZAPINEBionpharma Inc.8f485576-a4c4-45d4-816f-2e59fce9f5172026-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEUnit Dose Solutions, Inc.55669a10-93f3-cfd6-e063-6294a90aa0e62026-06-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.