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 3 of 6 · 101 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Olanzapine IntramuscularOLANZAPINEUBI Pharma Inc.6a279fe1-ed99-4a62-b2c7-831961470fa92026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEHEC Pharm USA Inc.4d1b83db-54db-d51f-e063-6394a90a4a692026-03-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312076
rxcui: 351108
rxcui: 351107
rxcui: 314155
unii: N7U69T4SZR
OLANZAPINEOLANZAPINEHEC Pharm USA Inc.4d34f8f3-edc8-0a68-e063-6394a90a9c1f2026-03-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200034
rxcui: 283639
rxcui: 312079
rxcui: 312077
rxcui: 314154
rxcui: 312078
unii: N7U69T4SZR
OlanzapineOLANZAPINEDr.Reddy's Laboratories Limitedaff02cff-d079-bc82-6182-a24c4c6e09a62026-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312076
rxcui: 351108
rxcui: 351107
rxcui: 314155
unii: N7U69T4SZR
OlanzapineOLANZAPINEDr. Reddy's Laboratories Inc.d474d5a9-d338-511d-5823-567c0a1bbf4d2026-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312079
rxcui: 314154
rxcui: 312078
unii: N7U69T4SZR
OLANZAPINEOLANZAPINEAnthea Pharma Private Limitede6ffcc56-63f9-4b12-a07a-c6177ffef5e82026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEMacleods Pharmaceuticals Limited8e095987-bdea-42f2-9550-c7155cf07d302026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200034
rxcui: 283639
rxcui: 312079
rxcui: 312077
rxcui: 314154
rxcui: 312078
unii: N7U69T4SZR
OlanzapineOLANZAPINEMacleods Pharmaceuticals Limiteddf43938a-3469-40eb-8166-f0a2fd29d6d82026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312076
rxcui: 351108
rxcui: 351107
rxcui: 314155
unii: N7U69T4SZR
OLANZAPINEOLANZAPINETorrent Pharmaceuticals Limited2cb1bebe-0ced-46d8-bf21-c28a9acc4a152026-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200034
rxcui: 312076
rxcui: 351108
rxcui: 283639
rxcui: 312079
rxcui: 312077
rxcui: 314154
rxcui: 351107
rxcui: 312078
rxcui: 314155
unii: N7U69T4SZR
OlanzapineOLANZAPINEAmerican Regent, Inc.e9ac2bd3-dbff-4b1a-952f-da3909c6e4ee2026-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINETeva Pharmaceuticals USA, Inc.dd0b2525-4e2f-44fc-9302-0ae4ebb1e1352026-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312076
rxcui: 351108
rxcui: 351107
rxcui: 314155
unii: N7U69T4SZR
OlanzapineOLANZAPINESandoz Incc44a96cc-817d-4eb5-a13a-00977f76e6662026-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEAmerican Health Packagingc0d705bf-b719-4c7b-b83d-c17d41cbbfad2026-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 283639
rxcui: 312077
unii: N7U69T4SZR
OlanzapineOLANZAPINESandoz Inc1e9666ef-4271-4834-8496-ccb3125d83db2026-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OLANZAPINEOLANZAPINEEugia US LLC9c745e2e-89d3-44d4-906e-704705c333102026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
ZyprexaOLANZAPINEH2-Pharma LLCb418946a-1ab4-4d89-a012-d94fc361a3c42026-02-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200034
rxcui: 312076
rxcui: 351108
rxcui: 283639
rxcui: 312079
rxcui: 312077
rxcui: 314154
rxcui: 351107
rxcui: 312078
rxcui: 314155
unii: N7U69T4SZR
OlanzapineOLANZAPINEAurobindo Pharma Limited636665be-9d7e-443a-8134-e8cc47e6ba242026-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200034
rxcui: 283639
rxcui: 312079
rxcui: 312077
rxcui: 314154
rxcui: 312078
unii: N7U69T4SZR
LYBALVIOLANZAPINE AND SAMIDORPHAN L-MALATEAlkermes, Inc.32ffddd1-4e2b-45d9-9b36-bb730167ec802026-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINECoupler LLC495efc49-7cdb-4b9e-e063-6394a90a547e2026-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312077
unii: N7U69T4SZR
OlanzapineOLANZAPINEAscend Laboratories, LLCe8626e68-088d-47ff-bf06-489a778815aa2025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200034
rxcui: 283639
rxcui: 312079
rxcui: 312077
rxcui: 314154
rxcui: 312078
unii: N7U69T4SZR

Reported adverse events (FAERS/openFDA)#

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