Olanzapine

Product NDC: 63187-321
11-digit product format: 631870321
Labeler code: 63187
Product ID: 63187-321_fcb7d340-a167-41f2-b85d-916c542067da
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Olanzapine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA076133
Marketing category: ANDA
Marketing start: 2011-10-24
Marketing end: 0000-00-00
Substance: OLANZAPINE
Active strength: 10 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	63187-321		D	Discontinued by firm		2026-08-03
excluded package	package	63187-321	63187-321-30	D	Discontinued by firm		2026-08-03

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 · 26 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-321-30	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-321-30	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63187-321-30	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63187-321-30	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63187-321-30	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63187-321-30	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63187-321-30	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63187-321-30	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63187-321-30	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63187-321-30	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63187-321-30	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63187-321-30	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	63187-321-30	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076133-001	OLANZAPINE	OLANZAPINE	15MG	TABLET / ORAL	AB		2012-04-23
A076133-002	OLANZAPINE	OLANZAPINE	20MG	TABLET / ORAL	AB		2011-10-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A076133-001	AB
A076133-002	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 3 · 82 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	A076133-001	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076133-002	OLANZAPINE	20MG	TABLET / ORAL	AB	2011-10-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076133-001	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076133-002	OLANZAPINE	20MG	TABLET / ORAL	AB	2011-10-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076133-001	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076133-002	OLANZAPINE	20MG	TABLET / ORAL	AB	2011-10-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076133-001	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076133-002	OLANZAPINE	20MG	TABLET / ORAL	AB	2011-10-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076133-001	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076133-002	OLANZAPINE	20MG	TABLET / ORAL	AB	2011-10-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076133-001	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076133-002	OLANZAPINE	20MG	TABLET / ORAL	AB	2011-10-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076133-001	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076133-002	OLANZAPINE	20MG	TABLET / ORAL	AB	2011-10-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076133-001	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076133-002	OLANZAPINE	20MG	TABLET / ORAL	AB	2011-10-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076133-001	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076133-002	OLANZAPINE	20MG	TABLET / ORAL	AB	2011-10-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076133-001	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076133-002	OLANZAPINE	20MG	TABLET / ORAL	AB	2011-10-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076133-001	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076133-002	OLANZAPINE	20MG	TABLET / ORAL	AB	2011-10-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076133-001	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076133-002	OLANZAPINE	20MG	TABLET / ORAL	AB	2011-10-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076133-001	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076133-002	OLANZAPINE	20MG	TABLET / ORAL	AB	2011-10-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076133-001	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076133-002	OLANZAPINE	20MG	TABLET / ORAL	AB	2011-10-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076133-001	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076133-002	OLANZAPINE	20MG	TABLET / ORAL	AB	2011-10-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076133-001	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076133-002	OLANZAPINE	20MG	TABLET / ORAL	AB	2011-10-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076133-001	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076133-002	OLANZAPINE	20MG	TABLET / ORAL	AB	2011-10-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076133-001	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076133-002	OLANZAPINE	20MG	TABLET / ORAL	AB	2011-10-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076133-001	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076133-002	OLANZAPINE	20MG	TABLET / ORAL	AB	2011-10-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076133-001	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076133-002	OLANZAPINE	20MG	TABLET / ORAL	AB	2011-10-24	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A076133-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076133-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076133-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076133-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076133-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076133-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076133-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076133-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076133-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076133-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076133-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076133-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076133-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076133-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076133-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076133-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076133-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076133-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076133-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076133-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076133-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076133-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076133-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076133-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076133-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076133-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076133-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076133-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076133-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076133-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076133-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076133-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076133-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076133-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076133-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076133-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076133-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076133-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076133-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076133-002	AB	1	`782e0a99824c…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
olanzapine	ACTIVE INGREDIENT	N7U69T4SZR	OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1
OLANZAPINE	ACTIVE MOIETY	N7U69T4SZR	OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1
Crospovidone	INACTIVE INGREDIENT	68401960MK	OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1

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 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olanzapine	OLANZAPINE	Dr. Reddy's Laboratories Ltd.	a4c525da-c2f6-b804-af49-601295922254	2026-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076133 application number: ANDA076133
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	ad350abc-a1fc-4be4-b2be-c629121552a0	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076133 application number: ANDA076133
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	1705bab2-a2f8-4534-b1fc-eb309cd2696b	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076133 application number: ANDA076133
Olanzapine	OLANZAPINE	Coupler LLC	51b508ff-dc55-ff36-e063-6294a90a900f	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076133 application number: ANDA076133
Olanzapine	OLANZAPINE	American Health Packaging	c0d705bf-b719-4c7b-b83d-c17d41cbbfad	2026-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076133 application number: ANDA076133
Olanzapine	OLANZAPINE	Major Pharmaceuticals	709d79a1-2742-4629-af43-161be166833a	2025-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076133 application number: ANDA076133