Olanzapine

Product NDC: 67046-0524
11-digit product format: 670460524
Labeler code: 67046
Product ID: 67046-0524_51b4e5f9-75f5-8ba8-e063-6294a90aa2dc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Olanzapine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Coupler LLC
Application: ANDA076133
Marketing category: ANDA
Marketing start: 2026-05-13
Substance: OLANZAPINE
Active strength: 20 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Olanzapine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OLANZAPINE	20 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
283639	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
51b508ff-dc55-ff36-e063-6294a90a900f	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
67046-0524-3	Olanzapine	30 in 1 BLISTER PACK	TABLET, FILM COATED	30		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 ndc (product): 67046-0524
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

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
283639	OLANZapine 20 MG Oral Tablet	PSN	51b508ff-dc55-ff36-e063-6294a90a900f	1
283639	olanzapine 20 MG Oral Tablet	SCD	51b508ff-dc55-ff36-e063-6294a90a900f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
67046-0524-3	67046052403	30 TABLET, FILM COATED in 1 BLISTER PACK (67046-0524-3)	2026-05-13	No	No	Current