Olanzapine

Product NDC: 14445-108
11-digit product format: 144450108
Labeler code: 14445
Product ID: 14445-108_5b7d091a-7e7a-46ac-ab13-49ef27b1b0a5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Olanzapine
Dosage form: TABLET
Route: ORAL
Labeler: Indoco Remedies Limited
Application: ANDA206155
Marketing category: ANDA
Marketing start: 2020-08-14
Marketing end: 0000-00-00
Substance: OLANZAPINE
Active strength: 8 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	14445-108		I	Inactivated by FDA	2026-08-11
excluded package	package	14445-108	14445-108-00	I	Inactivated by FDA	2026-08-11
excluded package	package	14445-108	14445-108-10	I	Inactivated by FDA	2026-08-11
excluded package	package	14445-108	14445-108-30	I	Inactivated by FDA	2026-08-11

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

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
A206155-001	OLANZAPINE	OLANZAPINE	2.5MG	TABLET / ORAL	2020-07-31
A206155-002	OLANZAPINE	OLANZAPINE	5MG	TABLET / ORAL	2020-07-31
A206155-003	OLANZAPINE	OLANZAPINE	7.5MG	TABLET / ORAL	2020-07-31
A206155-004	OLANZAPINE	OLANZAPINE	10MG	TABLET / ORAL	2020-07-31
A206155-005	OLANZAPINE	OLANZAPINE	15MG	TABLET / ORAL	2020-07-31
A206155-006	OLANZAPINE	OLANZAPINE	20MG	TABLET / ORAL	2020-07-31

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 · 222 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A206155-001	OLANZAPINE	2.5MG	TABLET / ORAL	2020-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206155-002	OLANZAPINE	5MG	TABLET / ORAL	2020-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206155-003	OLANZAPINE	7.5MG	TABLET / ORAL	2020-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206155-004	OLANZAPINE	10MG	TABLET / ORAL	2020-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206155-005	OLANZAPINE	15MG	TABLET / ORAL	2020-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206155-006	OLANZAPINE	20MG	TABLET / ORAL	2020-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206155-001	OLANZAPINE	2.5MG	TABLET / ORAL	2020-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206155-002	OLANZAPINE	5MG	TABLET / ORAL	2020-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206155-003	OLANZAPINE	7.5MG	TABLET / ORAL	2020-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206155-004	OLANZAPINE	10MG	TABLET / ORAL	2020-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206155-005	OLANZAPINE	15MG	TABLET / ORAL	2020-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206155-006	OLANZAPINE	20MG	TABLET / ORAL	2020-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206155-001	OLANZAPINE	2.5MG	TABLET / ORAL	2020-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206155-002	OLANZAPINE	5MG	TABLET / ORAL	2020-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206155-003	OLANZAPINE	7.5MG	TABLET / ORAL	2020-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206155-004	OLANZAPINE	10MG	TABLET / ORAL	2020-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206155-005	OLANZAPINE	15MG	TABLET / ORAL	2020-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206155-006	OLANZAPINE	20MG	TABLET / ORAL	2020-07-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206155-001	OLANZAPINE	2.5MG	TABLET / ORAL	2020-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206155-002	OLANZAPINE	5MG	TABLET / ORAL	2020-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206155-003	OLANZAPINE	7.5MG	TABLET / ORAL	2020-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206155-004	OLANZAPINE	10MG	TABLET / ORAL	2020-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206155-005	OLANZAPINE	15MG	TABLET / ORAL	2020-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206155-006	OLANZAPINE	20MG	TABLET / ORAL	2020-07-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206155-001	OLANZAPINE	2.5MG	TABLET / ORAL	2020-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206155-002	OLANZAPINE	5MG	TABLET / ORAL	2020-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206155-003	OLANZAPINE	7.5MG	TABLET / ORAL	2020-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206155-004	OLANZAPINE	10MG	TABLET / ORAL	2020-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206155-005	OLANZAPINE	15MG	TABLET / ORAL	2020-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206155-006	OLANZAPINE	20MG	TABLET / ORAL	2020-07-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206155-001	OLANZAPINE	2.5MG	TABLET / ORAL	2020-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206155-002	OLANZAPINE	5MG	TABLET / ORAL	2020-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206155-003	OLANZAPINE	7.5MG	TABLET / ORAL	2020-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206155-004	OLANZAPINE	10MG	TABLET / ORAL	2020-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206155-005	OLANZAPINE	15MG	TABLET / ORAL	2020-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206155-006	OLANZAPINE	20MG	TABLET / ORAL	2020-07-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206155-001	OLANZAPINE	2.5MG	TABLET / ORAL	2020-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206155-002	OLANZAPINE	5MG	TABLET / ORAL	2020-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206155-003	OLANZAPINE	7.5MG	TABLET / ORAL	2020-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206155-004	OLANZAPINE	10MG	TABLET / ORAL	2020-07-31	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206155-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206155-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206155-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206155-004	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206155-005	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206155-006	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206155-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206155-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206155-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206155-004	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206155-005	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206155-006	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206155-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206155-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206155-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206155-004	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206155-005	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206155-006	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A206155-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206155-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206155-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206155-004	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206155-005	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206155-006	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206155-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206155-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206155-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206155-004	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206155-005	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206155-006	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206155-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206155-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206155-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206155-004	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206155-005	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206155-006	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206155-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206155-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206155-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206155-004	AB	1	`5aa47cf7b7d7…`

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
14445-108-00	2026-01-29	C162847	48780-1	49896155-c67a-586f-e063-e6dba90add90	HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use OLANZAPINE TABLETS, safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996
14445-108-10	2026-01-29	C162847	48780-1	49896155-c67a-586f-e063-e6dba90add90	HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use OLANZAPINE TABLETS, safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996
14445-108-30	2026-01-29	C162847	48780-1	49896155-c67a-586f-e063-e6dba90add90	HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use OLANZAPINE TABLETS, safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
14445-108-00	Olanzapine	1000 in 1 BOTTLE	TABLET	1000	1
14445-108-10	Olanzapine	100 in 1 BLISTER PACK	TABLET	100	1
14445-108-30	Olanzapine	30 in 1 BOTTLE	TABLET	30	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
14445-108	OLANZAPINE TABLET [INDOCO REMEDIES LIMITED ]	1	Legacy NDC, 3 package rows	20200815_5b7d091a-7e7a-46ac-ab13-49ef27b1b0a5.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	5b7d091a-7e7a-46ac-ab13-49ef27b1b0a5	1
312077	OLANZapine 15 MG Oral Tablet	PSN	5b7d091a-7e7a-46ac-ab13-49ef27b1b0a5	1
200034	OLANZapine 2.5 MG Oral Tablet	PSN	5b7d091a-7e7a-46ac-ab13-49ef27b1b0a5	1
283639	OLANZapine 20 MG Oral Tablet	PSN	5b7d091a-7e7a-46ac-ab13-49ef27b1b0a5	1
312078	OLANZapine 5 MG Oral Tablet	PSN	5b7d091a-7e7a-46ac-ab13-49ef27b1b0a5	1
312079	OLANZapine 7.5 MG Oral Tablet	PSN	5b7d091a-7e7a-46ac-ab13-49ef27b1b0a5	1
314154	olanzapine 10 MG Oral Tablet	SCD	5b7d091a-7e7a-46ac-ab13-49ef27b1b0a5	1
312077	olanzapine 15 MG Oral Tablet	SCD	5b7d091a-7e7a-46ac-ab13-49ef27b1b0a5	1
200034	olanzapine 2.5 MG Oral Tablet	SCD	5b7d091a-7e7a-46ac-ab13-49ef27b1b0a5	1
283639	olanzapine 20 MG Oral Tablet	SCD	5b7d091a-7e7a-46ac-ab13-49ef27b1b0a5	1
312078	olanzapine 5 MG Oral Tablet	SCD	5b7d091a-7e7a-46ac-ab13-49ef27b1b0a5	1
312079	olanzapine 7.5 MG Oral Tablet	SCD	5b7d091a-7e7a-46ac-ab13-49ef27b1b0a5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
14445-108-00	14445010800	1000 TABLET in 1 BOTTLE (14445-108-00)	1000 tablet	2020-08-14	0000-00-00	No	No	Current
14445-108-10	14445010810	100 TABLET in 1 BLISTER PACK (14445-108-10)	100 tablet	2020-08-14	0000-00-00	No	No	Current
14445-108-30	14445010830	30 TABLET in 1 BOTTLE (14445-108-30)	30 tablet	2020-08-14	0000-00-00	No	No	Current