Olanzapine

Product NDC: 72189-578
11-digit product format: 721890578
Labeler code: 72189
Product ID: 72189-578_22528ae1-e370-48e1-e063-6294a90a3dd2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Olanzapine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Direct_Rx
Application: ANDA202862
Marketing category: ANDA
Marketing start: 2024-09-17
Substance: OLANZAPINE
Active strength: 7.5 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202862-001	OLANZAPINE	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2014-08-15
A202862-002	OLANZAPINE	OLANZAPINE	5MG	TABLET / ORAL	AB	2014-08-15
A202862-003	OLANZAPINE	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2014-08-15
A202862-004	OLANZAPINE	OLANZAPINE	10MG	TABLET / ORAL	AB	2014-08-15
A202862-005	OLANZAPINE	OLANZAPINE	15MG	TABLET / ORAL	AB	2014-08-15
A202862-006	OLANZAPINE	OLANZAPINE	20MG	TABLET / ORAL	AB	2014-08-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A202862-001	AB
A202862-002	AB
A202862-003	AB
A202862-004	AB
A202862-005	AB
A202862-006	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202862-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2014-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202862-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2014-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202862-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2014-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202862-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2014-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202862-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2014-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202862-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2014-08-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2014-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2014-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2014-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2014-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2014-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2014-08-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202862-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2014-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202862-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2014-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202862-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2014-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202862-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2014-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202862-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2014-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202862-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2014-08-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2014-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2014-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2014-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2014-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2014-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2014-08-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202862-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2014-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202862-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2014-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202862-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2014-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202862-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2014-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202862-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2014-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202862-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2014-08-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202862-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2014-08-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202862-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2014-08-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202862-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2014-08-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202862-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2014-08-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202862-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2014-08-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202862-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2014-08-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202862-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2014-08-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202862-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2014-08-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202862-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2014-08-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202862-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2014-08-15	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202862-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202862-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202862-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202862-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202862-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202862-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202862-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202862-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202862-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202862-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202862-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202862-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202862-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202862-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202862-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202862-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202862-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202862-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202862-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202862-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202862-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202862-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202862-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202862-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202862-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202862-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202862-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202862-004	AB	1	`2680178bc6a6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Olanzapine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OLANZAPINE	7.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
N7U69T4SZR	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312079	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
22528ae1-e36f-48e1-e063-6294a90a3dd2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
42e9462d-db65-453b-8069-8fb2df9182e8	Product name	1	20211216
12d02c27-e8da-47f1-b815-ccca982731ef	Product name	9	20170802
877783eb-030c-6e3f-0979-804cf94d8856	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72189-578-30	Olanzapine	30 in 1 BOTTLE	TABLET, FILM COATED	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-578-30	EA - Each	72189-578	b92fd0c0-8745-4e46-8260-d0101afd4191	1	2024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-578	OLANZAPINE TABLET, FILM COATED [DIRECT_RX]	1	Current NDC, 1 package rows	20240919_22528ae1-e36f-48e1-e063-6294a90a3dd2.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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	9eb6b0d1-b301-4847-88f5-f8613d550ecc	2026-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	PD-Rx Pharmaceuticals, Inc.	b6f0b2e2-3cbd-4564-8b3e-f811589af275	2026-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	8e5ef52d-315b-4055-9e52-403e6f896f24	2026-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	Redpharm Drug	54adae9e-6781-6a77-e063-6394a90ab5c8	2026-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	Coupler LLC	549dc142-adcd-99ed-e063-6294a90a37fa	2026-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	Coupler LLC	52bdaaaf-ab54-99d1-e063-6394a90a521f	2026-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	Coupler LLC	518a9400-edb8-6403-e063-6294a90a065d	2026-05-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	76a6ff21-7157-4213-8073-35837a3ac07e	2026-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	Macleods Pharmaceuticals Limited	8e095987-bdea-42f2-9550-c7155cf07d30	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	88edb3fc-fcb6-4483-859d-f830b077aca2	2026-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	Preferred Pharmaceuticals Inc.	5bded04a-d848-4ac6-b7c3-ff9b9fef3d29	2025-09-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	f6fd7ceb-1457-4c3e-9d30-4f658f39d37d	2025-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	c47f90fc-49fe-4f60-9da8-1365a1650dd9	2025-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	dcf8fcbf-636c-41ad-8084-c65ac2f117cc	2025-05-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	8586e828-34e7-4eb4-a933-6c688927478f	2025-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
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 application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	Direct_Rx	fcec190f-b865-c5d3-e053-6394a90a7e45	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	Direct_Rx	22528ae1-e36f-48e1-e063-6294a90a3dd2	2024-09-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862 ndc (product): 72189-578
Olanzapine	OLANZAPINE	NorthStar RxLLC	ea3259d5-36ee-4ac9-b849-9625626e2187	2024-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862
Olanzapine	OLANZAPINE	Proficient Rx LP	ce66d545-015b-41d5-80c3-964d78e36bfd	2023-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
N7U69T4SZR	OLANZAPINE	132539-06-1	OLANZAPINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312079	OLANZapine 7.5 MG Oral Tablet	PSN	22528ae1-e36f-48e1-e063-6294a90a3dd2	1
312079	olanzapine 7.5 MG Oral Tablet	SCD	22528ae1-e36f-48e1-e063-6294a90a3dd2	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72189-578-30	72189057830	30 TABLET, FILM COATED in 1 BOTTLE (72189-578-30)	2024-09-17	No	No	Current