FDA.reportPublic FDA data

NDC 42658-159-01 - Olanzapine

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
42658-159
Requested NDC
42658-159-01
Package NDCs from labels
42658-159-01, 42658-159-04, 42658-159-07
Manufacturer
Hisun Pharmaceuticals USA, Inc.
Effective date
2024-01-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Olanzapine - Hisun Pharmaceuticals USA, Inc.Hisun Pharmaceuticals USA, Inc.2024-01-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42658-159-01Olanzapine600 mg in 1 BOTTLETABLET, ORALLY DISINTEGRATING6001
42658-159-04Olanzapine1800 mg in 1 BOTTLETABLET, ORALLY DISINTEGRATING18001
42658-159-07Olanzapine10000 mg in 1 BOTTLETABLET, ORALLY DISINTEGRATING100001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42658-159OLANZAPINE TABLET OLANZAPINE TABLET, ORALLY DISINTEGRATING [HISUN PHARMACEUTICALS USA, INC.]13 package rows20250101_0bbf07bd-400d-4f2a-e063-6294a90a1ed4.zip

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 4 of 6 · 101 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Olanzapine and FluoxetineOLANZAPINE AND FUOXETINEPar Health USA, LLC2f6ceda3-3edc-4427-98a6-23e3c930c44d2025-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEApotex Corp.3347d1c8-04c9-5ce1-8cda-b38e0412b7092025-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200034
rxcui: 283639
rxcui: 312079
rxcui: 312077
rxcui: 314154
rxcui: 312078
unii: N7U69T4SZR
OlanzapineOLANZAPINECoupler LLC42d9ad47-52cc-ad11-e063-6394a90aedca2025-11-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200034
unii: N7U69T4SZR
OlanzapineOLANZAPINEQilu Pharmaceutical Co., Ltd.12ce860a-6f22-4db6-8acf-786b40f5a5a52025-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEAmerican Health Packaging75616c31-8fed-4014-a9f2-4a028eccd5862025-10-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200034
rxcui: 314154
rxcui: 312078
unii: N7U69T4SZR
Olanzapine and FluoxetineOLANZAPINE AND FLUOXETINEAvKAREf5f78ed2-4640-8528-c51c-d7bffa045d482025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINECoupler LLC40187874-447a-de20-e063-6394a90aafe72025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 283639
unii: N7U69T4SZR
OlanzapineOLANZAPINECoupler LLC3ed78a7d-4014-d280-e063-6294a90a8ee92025-09-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314154
unii: N7U69T4SZR
OlanzapineOLANZAPINEPreferred Pharmaceuticals Inc.cfc0f187-d3ff-4bbb-9129-0e94c6eda0ee2025-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200034
unii: N7U69T4SZR
Olanzapine IntramuscularOLANZAPINEPAI Holdings, LLC dba PAI Pharma9d9f25d5-4513-434a-a37a-392a0c978f2e2025-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINECoupler LLC37c88965-c51d-946d-e063-6394a90a012c2025-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312076
unii: N7U69T4SZR
OlanzapineOLANZAPINEBryant Ranch Prepack1866a03c-eac9-44a1-8f33-7dc6e8a8c06a2025-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312078
unii: N7U69T4SZR
OlanzapineOLANZAPINEBryant Ranch Prepack3c9963b1-c498-48a0-a3a1-1eaa6a1028fc2025-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314154
unii: N7U69T4SZR
OlanzapineOLANZAPINEBryant Ranch Prepackf6fd7ceb-1457-4c3e-9d30-4f658f39d37d2025-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314154
unii: N7U69T4SZR
OlanzapineOLANZAPINEBryant Ranch Prepackc47f90fc-49fe-4f60-9da8-1365a1650dd92025-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314154
unii: N7U69T4SZR
OlanzapineOLANZAPINEBryant Ranch Prepackdcf8fcbf-636c-41ad-8084-c65ac2f117cc2025-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200034
unii: N7U69T4SZR
OlanzapineOLANZAPINEBryant Ranch Prepack8586e828-34e7-4eb4-a933-6c688927478f2025-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312078
unii: N7U69T4SZR
OlanzapineOLANZAPINEBryant Ranch Prepackd5a9f78e-56f4-4249-800c-5f52a99fa84b2025-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351107
unii: N7U69T4SZR
OlanzapineOLANZAPINEBryant Ranch Prepackd3857220-d9ff-4820-bf53-f2384b59a1a62025-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314155
unii: N7U69T4SZR
OlanzapineOLANZAPINEBryant Ranch Prepacked93d6b9-912a-444a-a695-439d0bfb877a2025-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312076
unii: N7U69T4SZR

Reported adverse events (FAERS/openFDA)#

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