Olanzapine

Product NDC: 63629-8714
11-digit product format: 636298714
Labeler code: 63629
Product ID: 63629-8714_33629b13-1f42-05cd-e063-6294a90ada76
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Olanzapine
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA091265
Marketing category: ANDA
Marketing start: 2011-10-24
Substance: OLANZAPINE
Active strength: 15 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A091265-001	OLANZAPINE	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24
A091265-002	OLANZAPINE	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24
A091265-003	OLANZAPINE	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24
A091265-004	OLANZAPINE	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A091265-001	AB
A091265-002	AB
A091265-003	AB
A091265-004	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 5 · 164 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	A091265-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091265-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091265-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091265-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091265-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091265-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091265-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091265-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091265-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091265-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091265-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091265-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091265-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091265-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091265-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091265-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091265-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091265-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091265-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091265-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091265-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091265-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091265-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091265-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091265-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091265-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091265-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091265-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091265-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091265-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091265-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091265-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091265-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091265-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091265-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091265-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091265-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091265-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091265-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091265-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A091265-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091265-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091265-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091265-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091265-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091265-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091265-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091265-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091265-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091265-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091265-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091265-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091265-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091265-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091265-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091265-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091265-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091265-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091265-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091265-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091265-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091265-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091265-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091265-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091265-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091265-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091265-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091265-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091265-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091265-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091265-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091265-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091265-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091265-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091265-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091265-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091265-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091265-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091265-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091265-004	AB	1	`d06236e962d9…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OLANZAPINE	15 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
351107	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
d5a9f78e-56f4-4249-800c-5f52a99fa84b	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
63629-8714-1	Olanzapine	30 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	30		107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-8714-1	EA - Each	63629-8714	90f74bc4-d0b0-4edb-a8be-8b0ebe4634cf	1	2021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-8714	OLANZAPINE TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]	107	Current NDC, Legacy NDC, 1 package rows	20250424_d5a9f78e-56f4-4249-800c-5f52a99fa84b.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 1 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olanzapine	OLANZAPINE	Coupler LLC	37c88965-c51d-946d-e063-6394a90a012c	2025-06-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091265 application number: ANDA091265
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	d5a9f78e-56f4-4249-800c-5f52a99fa84b	2025-04-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091265 application number: ANDA091265 ndc (product): 63629-8714
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	d3857220-d9ff-4820-bf53-f2384b59a1a6	2025-04-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091265 application number: ANDA091265
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	ed93d6b9-912a-444a-a695-439d0bfb877a	2025-04-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091265 application number: ANDA091265
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	58f175a8-5549-4f9e-baf4-8dc340c2cfd5	2025-04-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091265 application number: ANDA091265
Olanzapine	OLANZAPINE	Golden State Medical Supply, Inc.	9847a0e4-24fc-f4e8-e053-2995a90a961e	2025-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091265 application number: ANDA091265
Olanzapine	OLANZAPINE	Apotex Corp.	96165590-b287-0ed9-3723-752af59aedad	2025-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091265 application number: ANDA091265
Olanzapine	OLANZAPINE	Coupler LLC	325d5d69-5133-79ea-e063-6294a90afdd0	2025-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091265 application number: ANDA091265

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
351107	OLANZapine 15 MG Disintegrating Oral Tablet	PSN	d5a9f78e-56f4-4249-800c-5f52a99fa84b	107
351107	olanzapine 15 MG Disintegrating Oral Tablet	SCD	d5a9f78e-56f4-4249-800c-5f52a99fa84b	107

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-8714-1	63629871401	30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63629-8714-1)	2011-10-24	0000-00-00	No	No	Current