NDC 42658-150-04 - 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: 42658-150
Requested NDC: 42658-150-04
Package NDCs from labels: 42658-150-01, 42658-150-04, 42658-150-07
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
Label	Manufacturer	Effective date	Type
Olanzapine - Hisun Pharmaceuticals USA, Inc.	Hisun Pharmaceuticals USA, Inc.	2024-01-01	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
42658-150-01	Olanzapine	75 mg in 1 BOTTLE	TABLET	75	1
42658-150-04	Olanzapine	225 mg in 1 BOTTLE	TABLET	225	1
42658-150-07	Olanzapine	1250 mg in 1 BOTTLE	TABLET	1250	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42658-150	OLANZAPINE TABLET OLANZAPINE TABLET, ORALLY DISINTEGRATING [HISUN PHARMACEUTICALS USA, INC.]	1	3 package rows	20250101_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 1 of 6 · 101 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olanzapine	OLANZAPINE	Coupler LLC	5af81f87-5582-aa23-e063-6294a90a1ee8	2026-09-08	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312078 unii: N7U69T4SZR
Olanzapine	OLANZAPINE	Hikma Pharmaceuticals USA Inc.	63bcfe98-d1fc-4cd7-9212-f59ee4dcc6d1	2026-08-25	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: N7U69T4SZR
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	c47ee16f-5a86-49f2-8d85-5f49a6c8d91e	2026-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 200034 unii: N7U69T4SZR
Olanzapine	OLANZAPINE	Cardinal Health 107, LLC	38a89689-efc2-4931-8f65-868dc0248d6a	2026-08-13	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 314154 rxcui: 312078 unii: N7U69T4SZR
Olanzapine	OLANZAPINE	Preferred Pharmaceuticals Inc.	d349d5b7-5658-46d6-9bba-e6f6361cebb9	2026-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312078 unii: N7U69T4SZR
Olanzapine	OLANZAPINE	Preferred Pharmaceuticals Inc.	5bded04a-d848-4ac6-b7c3-ff9b9fef3d29	2026-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312078 unii: N7U69T4SZR
Olanzapine	OLANZAPINE	Major Pharmaceuticals	709d79a1-2742-4629-af43-161be166833a	2026-07-27	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 283639 rxcui: 312077 unii: N7U69T4SZR
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	9eb6b0d1-b301-4847-88f5-f8613d550ecc	2026-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 283639 unii: N7U69T4SZR
Olanzapine	OLANZAPINE	PD-Rx Pharmaceuticals, Inc.	b6f0b2e2-3cbd-4564-8b3e-f811589af275	2026-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 283639 unii: N7U69T4SZR
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	3d69af75-7615-4ec2-b7ef-467b2558c5c8	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312078 unii: N7U69T4SZR
Olanzapine	OLANZAPINE	Dr. Reddy's Laboratories Ltd.	a4c525da-c2f6-b804-af49-601295922254	2026-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 283639 rxcui: 312077 unii: N7U69T4SZR
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	ad350abc-a1fc-4be4-b2be-c629121552a0	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 283639 unii: N7U69T4SZR
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	b513823d-927c-4111-8766-e6c37f84b221	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 314154 unii: N7U69T4SZR
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	68de2a51-69b2-4d99-be79-36a95a4bc475	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312079 unii: N7U69T4SZR
Olanzapine	OLANZAPINE	Major Pharmaceuticals	0ecbf540-572e-4ca4-b694-18ca1cd1c194	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 314154 rxcui: 312078 unii: N7U69T4SZR
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	1705bab2-a2f8-4534-b1fc-eb309cd2696b	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312077 unii: N7U69T4SZR
Olanzapine	OLANZAPINE	Camber Pharmaceuticals, Inc.	c1387008-6dc4-4f1e-ae29-fa7a0f0be684	2026-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: N7U69T4SZR
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	8e5ef52d-315b-4055-9e52-403e6f896f24	2026-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312078 unii: N7U69T4SZR
olanzapine	OLANZAPINE	Bionpharma Inc.	8f485576-a4c4-45d4-816f-2e59fce9f517	2026-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312076 rxcui: 351108 rxcui: 351107 rxcui: 314155 unii: N7U69T4SZR
Olanzapine	OLANZAPINE	Unit Dose Solutions, Inc.	55669a10-93f3-cfd6-e063-6294a90aa0e6	2026-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312078 unii: N7U69T4SZR

Reported adverse events (FAERS/openFDA)#

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