Olanzapine

Product NDC: 42254-203
11-digit product format: 422540203
Labeler code: 42254
Product ID: 42254-203_d6a92eba-0841-474b-96f3-778f060ab133
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Olanzapine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Rebel Distributors Corp
Application: ANDA076000
Marketing category: ANDA
Marketing start: 2011-10-24
Marketing end: 0000-00-00
Substance: OLANZAPINE
Active strength: 3 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
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	42254-203		I	Inactivated by FDA		2026-10-05
excluded package	package	42254-203	42254-203-30	I	Inactivated by FDA		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 · 44 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	42254-203-30	`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	42254-203-30	`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	42254-203-30	`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	42254-203-30	`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	42254-203-30	`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	42254-203-30	`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	42254-203-30	`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	42254-203-30	`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	42254-203-30	`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	42254-203-30	`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	42254-203-30	`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	42254-203-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	42254-203-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	42254-203-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	42254-203-30	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	42254-203-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	42254-203-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	42254-203-30	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	42254-203-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	42254-203-30	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	42254-203-30	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	42254-203-30	`110d247fa046…`	`a55b01930146…`

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A076000-001	OLANZAPINE	OLANZAPINE	2.5MG	TABLET / ORAL	2011-10-24
A076000-002	OLANZAPINE	OLANZAPINE	5MG	TABLET / ORAL	2011-10-24
A076000-003	OLANZAPINE	OLANZAPINE	7.5MG	TABLET / ORAL	2011-10-24
A076000-004	OLANZAPINE	OLANZAPINE	10MG	TABLET / ORAL	2011-10-24
A076000-005	OLANZAPINE	OLANZAPINE	15MG	TABLET / ORAL	2011-10-24

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 6 · 215 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	A076000-001	OLANZAPINE	2.5MG	TABLET / ORAL	2011-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076000-002	OLANZAPINE	5MG	TABLET / ORAL	2011-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076000-003	OLANZAPINE	7.5MG	TABLET / ORAL	2011-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076000-004	OLANZAPINE	10MG	TABLET / ORAL	2011-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076000-005	OLANZAPINE	15MG	TABLET / ORAL	2011-10-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076000-001	OLANZAPINE	2.5MG	TABLET / ORAL	2011-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076000-002	OLANZAPINE	5MG	TABLET / ORAL	2011-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076000-003	OLANZAPINE	7.5MG	TABLET / ORAL	2011-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076000-004	OLANZAPINE	10MG	TABLET / ORAL	2011-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076000-005	OLANZAPINE	15MG	TABLET / ORAL	2011-10-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076000-001	OLANZAPINE	2.5MG	TABLET / ORAL	2011-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076000-002	OLANZAPINE	5MG	TABLET / ORAL	2011-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076000-003	OLANZAPINE	7.5MG	TABLET / ORAL	2011-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076000-004	OLANZAPINE	10MG	TABLET / ORAL	2011-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076000-005	OLANZAPINE	15MG	TABLET / ORAL	2011-10-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076000-001	OLANZAPINE	2.5MG	TABLET / ORAL	2011-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076000-002	OLANZAPINE	5MG	TABLET / ORAL	2011-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076000-003	OLANZAPINE	7.5MG	TABLET / ORAL	2011-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076000-004	OLANZAPINE	10MG	TABLET / ORAL	2011-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076000-005	OLANZAPINE	15MG	TABLET / ORAL	2011-10-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076000-001	OLANZAPINE	2.5MG	TABLET / ORAL	2011-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076000-002	OLANZAPINE	5MG	TABLET / ORAL	2011-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076000-003	OLANZAPINE	7.5MG	TABLET / ORAL	2011-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076000-004	OLANZAPINE	10MG	TABLET / ORAL	2011-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076000-005	OLANZAPINE	15MG	TABLET / ORAL	2011-10-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076000-001	OLANZAPINE	2.5MG	TABLET / ORAL	2011-10-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076000-002	OLANZAPINE	5MG	TABLET / ORAL	2011-10-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076000-003	OLANZAPINE	7.5MG	TABLET / ORAL	2011-10-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076000-004	OLANZAPINE	10MG	TABLET / ORAL	2011-10-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076000-005	OLANZAPINE	15MG	TABLET / ORAL	2011-10-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076000-001	OLANZAPINE	2.5MG	TABLET / ORAL	2011-10-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076000-002	OLANZAPINE	5MG	TABLET / ORAL	2011-10-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076000-003	OLANZAPINE	7.5MG	TABLET / ORAL	2011-10-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076000-004	OLANZAPINE	10MG	TABLET / ORAL	2011-10-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076000-005	OLANZAPINE	15MG	TABLET / ORAL	2011-10-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076000-001	OLANZAPINE	2.5MG	TABLET / ORAL	2011-10-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076000-002	OLANZAPINE	5MG	TABLET / ORAL	2011-10-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076000-003	OLANZAPINE	7.5MG	TABLET / ORAL	2011-10-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076000-004	OLANZAPINE	10MG	TABLET / ORAL	2011-10-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076000-005	OLANZAPINE	15MG	TABLET / ORAL	2011-10-24	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A076000-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076000-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076000-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076000-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076000-005	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A076000-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076000-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076000-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076000-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076000-005	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076000-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076000-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076000-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076000-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076000-005	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076000-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076000-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076000-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076000-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076000-005	AB	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42254-203-30	2019-09-24	C162847	48780-1	9350213a-3be7-c013-e053-90daa90a1393	These highlights do not include all the information needed to use olanzapine tablets USP safely and effectively. See full prescribing information for olanzapine tablets USP. OLANZAPINE tablets USP for oral use. Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42254-203-30	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
42254-203-30	EA - Each	42254-203	ed25c106-383d-4e34-97e9-ef7c89a73f37	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Olanzapine	ACTIVE INGREDIENT	N7U69T4SZR	OLANZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
olanzapine	ACTIVE MOIETY	N7U69T4SZR	OLANZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	OLANZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CARRAGEENAN	INACTIVE INGREDIENT	5C69YCD2YJ	OLANZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OLANZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	OLANZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OLANZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	OLANZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OLANZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42254-203	OLANZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20120621_d6a92eba-0841-474b-96f3-778f060ab133.zip

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
314154	OLANZapine 10 MG Oral Tablet	PSN	d6a92eba-0841-474b-96f3-778f060ab133	1
200034	OLANZapine 2.5 MG Oral Tablet	PSN	d6a92eba-0841-474b-96f3-778f060ab133	1
312078	OLANZapine 5 MG Oral Tablet	PSN	d6a92eba-0841-474b-96f3-778f060ab133	1
314154	olanzapine 10 MG Oral Tablet	SCD	d6a92eba-0841-474b-96f3-778f060ab133	1
200034	olanzapine 2.5 MG Oral Tablet	SCD	d6a92eba-0841-474b-96f3-778f060ab133	1
312078	olanzapine 5 MG Oral Tablet	SCD	d6a92eba-0841-474b-96f3-778f060ab133	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
42254-203-30	42254020330	30 in 1 BOTTLE	Historical