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
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
42658-159-01	Olanzapine	600 mg in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	600	1
42658-159-04	Olanzapine	1800 mg in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	1800	1
42658-159-07	Olanzapine	10000 mg in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	10000	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42658-159	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 5 of 6 · 101 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olanzapine	OLANZAPINE	Golden State Medical Supply, Inc.	9847a0e4-24fc-f4e8-e053-2995a90a961e	2025-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312076 rxcui: 351108 rxcui: 351107 rxcui: 314155 unii: N7U69T4SZR
Olanzapine	OLANZAPINE	Coupler LLC	325d5d69-5133-79ea-e063-6294a90afdd0	2025-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 314155 unii: N7U69T4SZR
Olanzapine	OLANZAPINE	Jubilant Cadista Pharmacuticals Inc.	028aa88e-fa50-7aa8-cc0b-97c0c9a0357c	2025-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312076 rxcui: 351108 rxcui: 351107 rxcui: 314155 unii: N7U69T4SZR
Olanzapine	OLANZAPINE	Cadila Pharmaceuticals Limited	2ae07ad4-4e58-4740-9f02-035ec061fefc	2025-03-11	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 200034 rxcui: 283639 rxcui: 312079 rxcui: 312077 rxcui: 314154 rxcui: 312078 unii: N7U69T4SZR
Olanzapine	OLANZAPINE	NCS HealthCare of KY, LLC dba Vangard Labs	87b7fb23-c9b7-433f-bd17-cd3e91714c27	2025-03-03	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 200034 rxcui: 283639 rxcui: 312077 rxcui: 314154 rxcui: 312078 unii: N7U69T4SZR
Olanzapine	OLANZAPINE	Direct_Rx	fcec190f-b865-c5d3-e053-6394a90a7e45	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 200034 unii: N7U69T4SZR
Olanzapine	OLANZAPINE	Direct_Rx	22528ae1-e36f-48e1-e063-6294a90a3dd2	2024-09-17	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312079 unii: N7U69T4SZR
Olanzapine	OLANZAPINE	NorthStar RxLLC	ea3259d5-36ee-4ac9-b849-9625626e2187	2024-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 200034 rxcui: 283639 rxcui: 312079 rxcui: 312077 rxcui: 314154 rxcui: 312078 unii: N7U69T4SZR
Olanzapine	OLANZAPINE	Qilu Pharmaceutical Co., Ltd.	6077f5c4-01d7-4c1d-97a0-cb859f98ce68	2024-06-28	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 200034 rxcui: 283639 rxcui: 312079 rxcui: 312077 rxcui: 314154 rxcui: 312078 unii: N7U69T4SZR
Olanzapine	OLANZAPINE	Proficient Rx LP	024e8e9b-a4fc-4882-b080-c070467166a6	2024-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 283639 unii: N7U69T4SZR
0bbf07bd-400e-4f2a-e063-6294a90a1ed4			0bbf07bd-400d-4f2a-e063-6294a90a1ed4	2024-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier spl id: 0bbf07bd-400e-4f2a-e063-6294a90a1ed4 spl set id: 0bbf07bd-400d-4f2a-e063-6294a90a1ed4
Olanzapine	OLANZAPINE	NorthStar RxLLC	f4e41c2c-d32d-40c2-8afb-b6df998ba6b0	2023-10-10	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: N7U69T4SZR
Olanzapine	OLANZAPINE	Lannett Company, Inc.	002dd00f-7946-ea4f-e063-6294a90a5916	2023-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312076 rxcui: 351108 rxcui: 351107 rxcui: 314155 unii: N7U69T4SZR
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	09e48e71-4dd2-4538-91d7-5b284f6647d8	2023-03-29	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312078 unii: N7U69T4SZR
Olanzapine	OLANZAPINE	Proficient Rx LP	ce66d545-015b-41d5-80c3-964d78e36bfd	2023-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312078 unii: N7U69T4SZR
Olanzapine	OLANZAPINE	Dr. Reddy's Laboratories Ltd.	9a57a63e-f856-aafa-037a-c08f2fea6496	2022-10-03	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 200034 unii: N7U69T4SZR
Olanzapine	OLANZAPINE	Proficient Rx LP	1f4a2eaf-3a12-4ebe-b97f-0a7bfbc32572	2022-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 314154 unii: N7U69T4SZR
Olanzapine	OLANZAPINE	Proficient Rx LP	e40d54bf-7334-4418-8a87-ff85941adec1	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 200034 rxcui: 314154 unii: N7U69T4SZR
Olanzapine	OLANZAPINE	Proficient Rx LP	61424fa3-b09a-4267-a208-a7c7c3f69fe5	2020-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312077 unii: N7U69T4SZR
Olanzapine	OLANZAPINE	Aphena Pharma Solutions - Tennessee, LLC	b6ec5610-b4a6-4646-954a-0fe8b1d3e143	2020-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312077 unii: N7U69T4SZR

Reported adverse events (FAERS/openFDA)#

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