SEROQUEL

Product NDC: 69189-0484
11-digit product format: 691890484
Labeler code: 69189
Product ID: 69189-0484_adff3967-150b-47c7-b047-03458ee7a47d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Quetiapine fumarate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Avera McKennan Hospital
Application: NDA022047
Marketing category: NDA
Marketing start: 2016-01-13
Marketing end: 0000-00-00
Substance: QUETIAPINE FUMARATE
Active strength: 300 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: E
Listing certified through: 2018-12-31
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	69189-0484		I	Inactivated by FDA		2026-08-03
excluded package	package	69189-0484	69189-0484-1	I	Inactivated by FDA		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 · 44 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	69189-0484-1	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	69189-0484-1	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	69189-0484-1	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	69189-0484-1	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	69189-0484-1	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	69189-0484-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69189-0484-1	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69189-0484-1	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69189-0484-1	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69189-0484-1	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69189-0484-1	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69189-0484-1	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69189-0484-1	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69189-0484-1	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69189-0484-1	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69189-0484-1	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69189-0484-1	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69189-0484-1	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	69189-0484-1	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
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	69189-0484-1	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	69189-0484-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	69189-0484-1	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022047-001	SEROQUEL XR	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17
N022047-002	SEROQUEL XR	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-05-17
N022047-003	SEROQUEL XR	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17
N022047-004	SEROQUEL XR	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17
N022047-005	SEROQUEL XR	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-08-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
N022047-001	AB
N022047-002	AB
N022047-003	AB
N022047-004	AB
N022047-005	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 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022047-001	SEROQUEL XR	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022047-002	SEROQUEL XR	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022047-003	SEROQUEL XR	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022047-004	SEROQUEL XR	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022047-005	SEROQUEL XR	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-08-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022047-001	SEROQUEL XR	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022047-002	SEROQUEL XR	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022047-003	SEROQUEL XR	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022047-004	SEROQUEL XR	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022047-005	SEROQUEL XR	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-08-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022047-001	SEROQUEL XR	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022047-002	SEROQUEL XR	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022047-003	SEROQUEL XR	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022047-004	SEROQUEL XR	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022047-005	SEROQUEL XR	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-08-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022047-001	SEROQUEL XR	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022047-002	SEROQUEL XR	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022047-003	SEROQUEL XR	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022047-004	SEROQUEL XR	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022047-005	SEROQUEL XR	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-08-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022047-001	SEROQUEL XR	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022047-002	SEROQUEL XR	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022047-003	SEROQUEL XR	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022047-004	SEROQUEL XR	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022047-005	SEROQUEL XR	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-08-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022047-001	SEROQUEL XR	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022047-002	SEROQUEL XR	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022047-003	SEROQUEL XR	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022047-004	SEROQUEL XR	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022047-005	SEROQUEL XR	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-08-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022047-001	SEROQUEL XR	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022047-002	SEROQUEL XR	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022047-003	SEROQUEL XR	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022047-004	SEROQUEL XR	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022047-005	SEROQUEL XR	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-08-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022047-001	SEROQUEL XR	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022047-002	SEROQUEL XR	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022047-003	SEROQUEL XR	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022047-004	SEROQUEL XR	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022047-005	SEROQUEL XR	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-08-11	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 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	N022047-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022047-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022047-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022047-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022047-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022047-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022047-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022047-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022047-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022047-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022047-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022047-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022047-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022047-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022047-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022047-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022047-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022047-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022047-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022047-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022047-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022047-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022047-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022047-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022047-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022047-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022047-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022047-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022047-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022047-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022047-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022047-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022047-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022047-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022047-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022047-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022047-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022047-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022047-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022047-005	AB	1	`5bbf6a4d5a75…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5ef42f82-f087-0d2c-105f-f791ca69210e	Product name	8	20250729
21205abd-8c89-4943-9f85-908f3d4fc3bb	Product name	5	20230501

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69189-0484-1	2020-01-31	C162847	48780-1	9d75b9cf-d2f5-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use SEROQUEL XR safely and effectively. See full prescribing information for SEROQUEL XR. SEROQUEL XR ® (quetiapine fumarate) extended-release tablets, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69189-0484-1	SEROQUELXR	1 in 1 DOSE PACK	TABLET, EXTENDED RELEASE	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69189-0484	SEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [AVERA MCKENNAN HOSPITAL]	1	Legacy NDC, 1 package rows	20170414_63cf6e35-4d68-4316-8579-823419f386de.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SEROQUEL XR	QUETIAPINE	H2-Pharma, LLC	ab959a35-d0ba-4f18-8f2e-6619d88b16e3	2026-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022047 application number: NDA022047
SEROQUEL XR	QUETIAPINE	AstraZeneca Pharmaceuticals LP	473a3ac4-67f4-4782-baa9-7f9bdd8761f4	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022047 application number: NDA022047

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2S3PL1B6UJ	QUETIAPINE FUMARATE	111974-72-2	QUETIAPINE FUMARATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
721794	QUEtiapine fumarate 300 MG 24HR Extended Release Oral Tablet	PSN	63cf6e35-4d68-4316-8579-823419f386de	1
721795	SEROQUEL XR 300 MG 24HR Extended Release Oral Tablet	PSN	63cf6e35-4d68-4316-8579-823419f386de	1
721795	24 HR quetiapine 300 MG Extended Release Oral Tablet [Seroquel]	SBD	63cf6e35-4d68-4316-8579-823419f386de	1
721794	24 HR quetiapine 300 MG Extended Release Oral Tablet	SCD	63cf6e35-4d68-4316-8579-823419f386de	1
721795	24 HR Seroquel 300 MG Extended Release Oral Tablet	SY	63cf6e35-4d68-4316-8579-823419f386de	1
721794	quetiapine 300 MG (as quetiapine fumarate 345 MG) 24 HR Extended Release Oral Tablet	SY	63cf6e35-4d68-4316-8579-823419f386de	1
721794	quetiapine 300 MG 24 HR Extended Release Oral Tablet	SY	63cf6e35-4d68-4316-8579-823419f386de	1
721795	Seroquel XR 300 MG (quetiapine fumarate 345 MG) 24 HR Extended Release Oral Tablet	SY	63cf6e35-4d68-4316-8579-823419f386de	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
69189-0484-1	69189048401	1 in 1 DOSE PACK	Historical