FDA.reportPublic FDA data

OLANZapine 5 MG Oral Tablet

RxCUI
312078
RxNorm name
OLANZapine 5 MG Oral Tablet
Display name
OLANZapine 5 MG Oral Tablet
Full name
OLANZapine 5 MG Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:17

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 2 · 30 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OlanzapineOLANZAPINECoupler LLC5af81f87-5582-aa23-e063-6294a90a1ee82026-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312078
OlanzapineOLANZAPINECardinal Health 107, LLC38a89689-efc2-4931-8f65-868dc0248d6a2026-08-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312078
OlanzapineOLANZAPINEPreferred Pharmaceuticals Inc.d349d5b7-5658-46d6-9bba-e6f6361cebb92026-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312078
OlanzapineOLANZAPINEPreferred Pharmaceuticals Inc.5bded04a-d848-4ac6-b7c3-ff9b9fef3d292026-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312078
OlanzapineOLANZAPINEREMEDYREPACK INC.3d69af75-7615-4ec2-b7ef-467b2558c5c82026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312078
OlanzapineOLANZAPINEMajor Pharmaceuticals0ecbf540-572e-4ca4-b694-18ca1cd1c1942026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312078
OlanzapineOLANZAPINEREMEDYREPACK INC.8e5ef52d-315b-4055-9e52-403e6f896f242026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312078
OlanzapineOLANZAPINEUnit Dose Solutions, Inc.55669a10-93f3-cfd6-e063-6294a90aa0e62026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312078
OlanzapineOLANZAPINEREMEDYREPACK INC.e830f488-c689-40f6-9351-f9c7454ff1ea2026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312078
OlanzapineOLANZAPINERedpharm Drug54adae9e-6781-6a77-e063-6394a90ab5c82026-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312078
OlanzapineOLANZAPINECoupler LLC52b99337-afa8-a6f9-e063-6294a90a20382026-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312078
OlanzapineOLANZAPINEGolden State Medical Supply, Inc.a1dfb4e7-4143-4422-b7a7-292e4fd750442026-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312078
OlanzapineOLANZAPINEModavar Pharmaceuticals LLCf0943b4e-6bdc-48c1-8ecd-39cf732e16f52026-04-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312078
OLANZAPINEOLANZAPINEHEC Pharm USA Inc.4d34f8f3-edc8-0a68-e063-6394a90a9c1f2026-03-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312078
OlanzapineOLANZAPINEDr. Reddy's Laboratories Inc.d474d5a9-d338-511d-5823-567c0a1bbf4d2026-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312078
OlanzapineOLANZAPINEMacleods Pharmaceuticals Limited8e095987-bdea-42f2-9550-c7155cf07d302026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312078
OLANZAPINEOLANZAPINETorrent Pharmaceuticals Limited2cb1bebe-0ced-46d8-bf21-c28a9acc4a152026-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312078
OlanzapineOLANZAPINEAurobindo Pharma Limited636665be-9d7e-443a-8134-e8cc47e6ba242026-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312078
OlanzapineOLANZAPINEAscend Laboratories, LLCe8626e68-088d-47ff-bf06-489a778815aa2025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312078
OlanzapineOLANZAPINEApotex Corp.3347d1c8-04c9-5ce1-8cda-b38e0412b7092025-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312078

Reported adverse events (FAERS/openFDA)#

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

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 2 of 2 · 50 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
52b99337-afa8-a6f9-e063-6294a90a2038OLANZapine 5 MG Oral Tablet [PSN] · olanzapine 5 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 199620260526
4d34f8f3-edc8-0a68-e063-6394a90a9c1fOLANZapine 5 MG Oral Tablet [PSN] · olanzapine 5 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 199620260316
df73e518-caea-a73b-e053-2995a90a69f5OLANZapine 5 MG Oral Tablet [PSN] · olanzapine 5 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets for Oral use Initial U.S. Approval: 199620220520
5b7d091a-7e7a-46ac-ab13-49ef27b1b0a5OLANZapine 5 MG Oral Tablet [PSN] · olanzapine 5 MG Oral Tablet [SCD]21HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use OLANZAPINE TABLETS, safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 199620200814
5a1dc228-b757-5f2b-e053-2991aa0adcccOLANZapine 5 MG Oral Tablet [PSN] · olanzapine 5 MG Oral Tablet [SCD]21522 Olanzapine 5 mg 523 Olanzapine 15 mg These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 199620170926
842b438f-86c7-44f2-a614-06915757a4ddOLANZapine 5 MG Oral Tablet [PSN] · olanzapine 5 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use olanzapine tablets USP safely and effectively. See full prescribing information for olanzapine tablets USP. OLANZAPINE tablets USP for oral use. Initial U.S. Approval: 199620120810
d6a92eba-0841-474b-96f3-778f060ab133OLANZapine 5 MG Oral Tablet [PSN] · olanzapine 5 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use olanzapine tablets USP safely and effectively. See full prescribing information for olanzapine tablets USP. OLANZAPINE tablets USP for oral use. Initial U.S. Approval: 199620120418
71c6577c-ffea-4934-bc10-2d35942f8a16OLANZapine 5 MG Oral Tablet [PSN] · olanzapine 5 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use ZYPREXA safely and effectively. See full prescribing information for ZYPREXA. ZYPREXA (olanzapine) Tablet for Oral use ZYPREXA ZYDIS (olanzapine) Tablet, Orally Disintegrating for Oral use ZYPREXA IntraMuscular (olanzapine) Injection, Powder, For Solution for Intramuscular use Initial U.S. Approval: 199620111004
a3c9ea17-3793-494a-8b32-44e48f9f4503OLANZapine 5 MG Oral Tablet [PSN] · olanzapine 5 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use ZYPREXA safely and effectively. See full prescribing information for ZYPREXA. ZYPREXA (olanzapine) Tablet for Oral use ZYPREXA ZYDIS (olanzapine) Tablet, Orally Disintegrating for Oral use ZYPREXA IntraMuscular (olanzapine) Injection, Powder, For Solution for Intramuscular use Initial U.S. Approval: 199620101201
66ef201f-85eb-44f0-9ef0-1b618c6e0bffOLANZapine 5 MG Oral Tablet [PSN] · olanzapine 5 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use ZYPREXA safely and effectively. See full prescribing information for ZYPREXA. ZYPREXA (olanzapine) Tablet for Oral use ZYPREXA ZYDIS (olanzapine) Tablet, Orally Disintegrating for Oral use ZYPREXA IntraMuscular (olanzapine) Injection, Powder, For Solution for Intramuscular use Initial U.S. Approval: 199620091130