Olanzapine

Product NDC: 69543-383
11-digit product format: 695430383
Labeler code: 69543
Product ID: 69543-383_e78e66e4-82ab-47a9-8633-d304cb6bac1e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Olanzapine
Dosage form: TABLET
Route: ORAL
Labeler: Virtus Pharmaceuticals, LLC
Application: ANDA204319
Marketing category: ANDA
Marketing start: 2018-01-19
Marketing end: 0000-00-00
Substance: OLANZAPINE
Active strength: 10 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	69543-383		D	Discontinued by firm	2026-08-03
excluded package	package	69543-383	69543-383-30	D	Discontinued by firm	2026-08-03
excluded package	package	69543-383	69543-383-90	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 · 27 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69543-383-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69543-383-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69543-383-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69543-383-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69543-383-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69543-383-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69543-383-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69543-383-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69543-383-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69543-383-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69543-383-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69543-383-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69543-383-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69543-383-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69543-383-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69543-383-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69543-383-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69543-383-30	`0efc9e666f02…`	`f202fb6c5f17…`

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
A204319-001	OLANZAPINE	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2016-01-27
A204319-002	OLANZAPINE	OLANZAPINE	5MG	TABLET / ORAL	AB	2016-01-27
A204319-003	OLANZAPINE	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2016-01-27
A204319-004	OLANZAPINE	OLANZAPINE	10MG	TABLET / ORAL	AB	2016-01-27
A204319-005	OLANZAPINE	OLANZAPINE	15MG	TABLET / ORAL	AB	2016-01-27
A204319-006	OLANZAPINE	OLANZAPINE	20MG	TABLET / ORAL	AB	2016-01-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204319-001	AB
A204319-002	AB
A204319-003	AB
A204319-004	AB
A204319-005	AB
A204319-006	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	A204319-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2016-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204319-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2016-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204319-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2016-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204319-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2016-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204319-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2016-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204319-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2016-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204319-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2016-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204319-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2016-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204319-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2016-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204319-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2016-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204319-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2016-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204319-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2016-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204319-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2016-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204319-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2016-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204319-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2016-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204319-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2016-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204319-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2016-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204319-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2016-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204319-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2016-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204319-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2016-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204319-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2016-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204319-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2016-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204319-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2016-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204319-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2016-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204319-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2016-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204319-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2016-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204319-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2016-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204319-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2016-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204319-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2016-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204319-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2016-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204319-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2016-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204319-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2016-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204319-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2016-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204319-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2016-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204319-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2016-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204319-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2016-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204319-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2016-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204319-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2016-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204319-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2016-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204319-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2016-01-27	`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	A204319-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204319-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204319-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204319-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204319-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204319-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204319-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204319-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204319-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204319-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204319-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204319-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204319-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204319-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204319-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204319-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204319-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204319-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204319-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204319-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204319-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204319-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204319-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204319-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204319-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204319-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204319-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204319-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204319-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204319-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204319-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204319-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204319-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204319-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204319-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204319-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204319-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204319-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204319-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204319-004	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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69543-383-30	EA - Each	69543-383	f4217873-beb1-48f6-95e5-439c7441c50e	1	2018-02-20
69543-383-90	EA - Each	69543-383	f1fd408e-2338-41df-acac-dd82a7cb3290	1	2018-02-20

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olanzapine	OLANZAPINE	Upsher-Smith Laboratories, LLC	dbe23f33-9e7d-49a7-8528-fa290661a96f	2025-10-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204319 application number: ANDA204319
Olanzapine	OLANZAPINE	Qilu Pharmaceutical Co., Ltd.	6077f5c4-01d7-4c1d-97a0-cb859f98ce68	2024-06-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204319 application number: ANDA204319

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	78fc032d-d6f4-4953-9a35-ac386f62e232	4
314154	olanzapine 10 MG Oral Tablet	SCD	78fc032d-d6f4-4953-9a35-ac386f62e232	4
314154	OLANZapine 10 MG Oral Tablet	PSN	534566ac-7174-4354-a1ee-24b144a5d660	2
314154	olanzapine 10 MG Oral Tablet	SCD	534566ac-7174-4354-a1ee-24b144a5d660	2
314154	OLANZapine 10 MG Oral Tablet	PSN	c1cb3de5-7bee-4baa-9128-1d5062067482	1
314154	olanzapine 10 MG Oral Tablet	SCD	c1cb3de5-7bee-4baa-9128-1d5062067482	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69543-383-30	69543038330	30 TABLET in 1 BOTTLE (69543-383-30)	30 tablet	2018-01-19	0000-00-00	No	No	Current
69543-383-90	69543038390	90 TABLET in 1 BOTTLE (69543-383-90)	90 tablet	2018-01-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Olanzapine	REMEDYREPACK INC.	2024-02-28	HUMAN PRESCRIPTION DRUG LABEL	5
Olanzapine	Bryant Ranch Prepack	2022-09-01	HUMAN PRESCRIPTION DRUG LABEL	4
Olanzapine	Virtus Pharmaceuticals, LLC \| Qilu Pharmaceutical Co., Ltd.(High Tech Zone Site) \| Qilu Pharmaceutical Co., Ltd. (Biological Industrial Park)	2022-05-31	HUMAN PRESCRIPTION DRUG LABEL	9
Olanzapine	Quality Care Products, LLC	2021-04-15	HUMAN PRESCRIPTION DRUG LABEL	2
Olanzapine	A-S Medication Solutions	2019-11-05	HUMAN PRESCRIPTION DRUG LABEL	1
Olanzapine	A-S Medication Solutions	2018-12-18	Human Prescription Drug Label	2