Olanzapine

Product NDC: 53002-1505
11-digit product format: 530021505
Labeler code: 53002
Product ID: 53002-1505_b3446bde-0f31-42b7-9b4c-c5073a8b8fc1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Olanzapine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA090798
Marketing category: ANDA
Marketing start: 2012-04-23
Marketing end: 0000-00-00
Substance: OLANZAPINE
Active strength: 5 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53002-1505		I	Inactivated by FDA		2026-08-10
excluded package	package	53002-1505	53002-1505-3	I	Inactivated by FDA		2026-08-10

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 · 22 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		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-1505-3	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-1505-3	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-1505-3	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-1505-3	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-1505-3	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-1505-3	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-1505-3	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-1505-3	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-1505-3	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53002-1505-3	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53002-1505-3	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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	TE codes	Approval date
A090798-001	OLANZAPINE	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23
A090798-002	OLANZAPINE	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23
A090798-003	OLANZAPINE	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23
A090798-004	OLANZAPINE	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23
A090798-005	OLANZAPINE	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23
A090798-006	OLANZAPINE	OLANZAPINE	20MG	TABLET / ORAL	AB	2012-04-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A090798-001	AB
A090798-002	AB
A090798-003	AB
A090798-004	AB
A090798-005	AB
A090798-006	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 7 · 246 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	A090798-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090798-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090798-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090798-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090798-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090798-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2012-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090798-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090798-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090798-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090798-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090798-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090798-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2012-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090798-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090798-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090798-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090798-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090798-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090798-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2012-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090798-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090798-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090798-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090798-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090798-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090798-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2012-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090798-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090798-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090798-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090798-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090798-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090798-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2012-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090798-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090798-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090798-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090798-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090798-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090798-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2012-04-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090798-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090798-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090798-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090798-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 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	A090798-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090798-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090798-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090798-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090798-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090798-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090798-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090798-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090798-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090798-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090798-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090798-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090798-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090798-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090798-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090798-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090798-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090798-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090798-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090798-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090798-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090798-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090798-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090798-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090798-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090798-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090798-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090798-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090798-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090798-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090798-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090798-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090798-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090798-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090798-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090798-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090798-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090798-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090798-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090798-004	AB	1	`2680178bc6a6…`

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#

Effective, Related label table
Effective	Related label
2025-01-30	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
2023-06-08	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
2023-01-30	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
2020-12-15	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
2020-01-31	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	Strength	SPL version
53002-1505-3	Olanzapine	30 in 1 BOTTLE	TABLET, FILM COATED	30		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-1505	OLANZAPINE TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]	5	Legacy NDC, 1 package rows	20230609_c26391b1-fc43-4e9e-be05-0c47ab635939.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olanzapine	OLANZAPINE	Cardinal Health 107, LLC	5ba67321-6988-46ea-97a0-549954e2c405	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090798 application number: ANDA090798
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	e830f488-c689-40f6-9351-f9c7454ff1ea	2026-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090798 application number: ANDA090798
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	032e589c-47b1-4eb1-9466-8160297b81e9	2026-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090798 application number: ANDA090798
Olanzapine	OLANZAPINE	Golden State Medical Supply, Inc.	a1dfb4e7-4143-4422-b7a7-292e4fd75044	2026-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090798 application number: ANDA090798
Olanzapine	OLANZAPINE	Apotex Corp.	3347d1c8-04c9-5ce1-8cda-b38e0412b709	2025-11-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090798 application number: ANDA090798
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	1866a03c-eac9-44a1-8f33-7dc6e8a8c06a	2025-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090798 application number: ANDA090798
Olanzapine	OLANZAPINE	Proficient Rx LP	024e8e9b-a4fc-4882-b080-c070467166a6	2024-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090798 application number: ANDA090798
Olanzapine	OLANZAPINE	Proficient Rx LP	e40d54bf-7334-4418-8a87-ff85941adec1	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090798 application number: ANDA090798
Olanzapine	OLANZAPINE	Aphena Pharma Solutions - Tennessee, LLC	b6ec5610-b4a6-4646-954a-0fe8b1d3e143	2020-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090798 application number: ANDA090798
Olanzapine	OLANZAPINE	Proficient Rx LP	7772a4c2-1fb1-412b-9e3b-ef3d693517a2	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090798 application number: ANDA090798

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
312078	OLANZapine 5 MG Oral Tablet	PSN	c26391b1-fc43-4e9e-be05-0c47ab635939	5
312078	olanzapine 5 MG Oral Tablet	SCD	c26391b1-fc43-4e9e-be05-0c47ab635939	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-1505-3	53002150503	30 TABLET, FILM COATED in 1 BOTTLE (53002-1505-3)	2018-10-01	0000-00-00	No	No	Current