Olanzapine

Product NDC: 70518-0026
11-digit product format: 705180026
Labeler code: 70518
Product ID: 70518-0026_5b279cb7-139c-6a47-e053-2991aa0acd53
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Olanzapine
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA091038
Marketing category: ANDA
Marketing start: 2016-12-05
Marketing end: 0000-00-00
Substance: OLANZAPINE
Active strength: 5 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	70518-0026		D	Discontinued by firm		2026-10-05
excluded package	package	70518-0026	70518-0026-0	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-0026-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-0026-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-0026-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-0026-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-0026-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-0026-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-0026-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-0026-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-0026-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-0026-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-0026-0	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70518-0026-0	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
A091038-001	OLANZAPINE	OLANZAPINE	2.5MG	TABLET / ORAL	2012-04-23
A091038-002	OLANZAPINE	OLANZAPINE	5MG	TABLET / ORAL	2012-04-23
A091038-003	OLANZAPINE	OLANZAPINE	7.5MG	TABLET / ORAL	2012-04-23
A091038-004	OLANZAPINE	OLANZAPINE	10MG	TABLET / ORAL	2012-04-23
A091038-005	OLANZAPINE	OLANZAPINE	15MG	TABLET / ORAL	2012-04-23
A091038-006	OLANZAPINE	OLANZAPINE	20MG	TABLET / ORAL	2012-04-23

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 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A091038-001	OLANZAPINE	2.5MG	TABLET / ORAL	2012-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091038-002	OLANZAPINE	5MG	TABLET / ORAL	2012-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091038-003	OLANZAPINE	7.5MG	TABLET / ORAL	2012-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091038-004	OLANZAPINE	10MG	TABLET / ORAL	2012-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091038-005	OLANZAPINE	15MG	TABLET / ORAL	2012-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091038-006	OLANZAPINE	20MG	TABLET / ORAL	2012-04-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091038-001	OLANZAPINE	2.5MG	TABLET / ORAL	2012-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091038-002	OLANZAPINE	5MG	TABLET / ORAL	2012-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091038-003	OLANZAPINE	7.5MG	TABLET / ORAL	2012-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091038-004	OLANZAPINE	10MG	TABLET / ORAL	2012-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091038-005	OLANZAPINE	15MG	TABLET / ORAL	2012-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091038-006	OLANZAPINE	20MG	TABLET / ORAL	2012-04-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091038-001	OLANZAPINE	2.5MG	TABLET / ORAL	2012-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091038-002	OLANZAPINE	5MG	TABLET / ORAL	2012-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091038-003	OLANZAPINE	7.5MG	TABLET / ORAL	2012-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091038-004	OLANZAPINE	10MG	TABLET / ORAL	2012-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091038-005	OLANZAPINE	15MG	TABLET / ORAL	2012-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091038-006	OLANZAPINE	20MG	TABLET / ORAL	2012-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091038-001	OLANZAPINE	2.5MG	TABLET / ORAL	2012-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091038-002	OLANZAPINE	5MG	TABLET / ORAL	2012-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091038-003	OLANZAPINE	7.5MG	TABLET / ORAL	2012-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091038-004	OLANZAPINE	10MG	TABLET / ORAL	2012-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091038-005	OLANZAPINE	15MG	TABLET / ORAL	2012-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091038-006	OLANZAPINE	20MG	TABLET / ORAL	2012-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091038-001	OLANZAPINE	2.5MG	TABLET / ORAL	2012-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091038-002	OLANZAPINE	5MG	TABLET / ORAL	2012-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091038-003	OLANZAPINE	7.5MG	TABLET / ORAL	2012-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091038-004	OLANZAPINE	10MG	TABLET / ORAL	2012-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091038-005	OLANZAPINE	15MG	TABLET / ORAL	2012-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091038-006	OLANZAPINE	20MG	TABLET / ORAL	2012-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091038-001	OLANZAPINE	2.5MG	TABLET / ORAL	2012-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091038-002	OLANZAPINE	5MG	TABLET / ORAL	2012-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091038-003	OLANZAPINE	7.5MG	TABLET / ORAL	2012-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091038-004	OLANZAPINE	10MG	TABLET / ORAL	2012-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091038-005	OLANZAPINE	15MG	TABLET / ORAL	2012-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091038-006	OLANZAPINE	20MG	TABLET / ORAL	2012-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091038-001	OLANZAPINE	2.5MG	TABLET / ORAL	2012-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091038-002	OLANZAPINE	5MG	TABLET / ORAL	2012-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091038-003	OLANZAPINE	7.5MG	TABLET / ORAL	2012-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091038-004	OLANZAPINE	10MG	TABLET / ORAL	2012-04-23	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 162 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-05-31 18:47 UTC	2024-05	A091038-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091038-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091038-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091038-004	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091038-005	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091038-006	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091038-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091038-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091038-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091038-004	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091038-005	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091038-006	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091038-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091038-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091038-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091038-004	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091038-005	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091038-006	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091038-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091038-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091038-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091038-004	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091038-005	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091038-006	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091038-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091038-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091038-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091038-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091038-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091038-006	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091038-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091038-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091038-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091038-004	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091038-005	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091038-006	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091038-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091038-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091038-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091038-004	AB	1	`782e0a99824c…`

Reported adverse events (FAERS/openFDA)#

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