SEROQUEL

Product NDC: 64725-0284
11-digit product format: 647250284
Labeler code: 64725
Product ID: 64725-0284_09f9c7b9-7622-4089-b6b9-8e5be366a398
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Quetiapine fumarate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: TYA Pharmaceuticals
Application: NDA022047
Marketing category: NDA
Marketing start: 2007-07-16
Marketing end: 0000-00-00
Substance: QUETIAPINE FUMARATE
Active strength: 400 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
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	64725-0284		I	Inactivated by FDA		2026-08-03
excluded package	package	64725-0284	64725-0284-1	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	64725-0284-1	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	64725-0284-1	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	64725-0284-1	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	64725-0284-1	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	64725-0284-1	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	64725-0284-1	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	64725-0284-1	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	64725-0284-1	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	64725-0284-1	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	64725-0284-1	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	64725-0284-1	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	64725-0284-1	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	64725-0284-1	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	64725-0284-1	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	64725-0284-1	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	64725-0284-1	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	64725-0284-1	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	64725-0284-1	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	64725-0284-1	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	64725-0284-1	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	64725-0284-1	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	64725-0284-1	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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
64725-0284-1	2020-01-31	C162847	48780-1	9d75b9d1-14cd-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
64725-0284-1	SEROQUEL XR	60 in 1 BOTTLE	TABLET, EXTENDED RELEASE	60		10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
QUETIAPINE FUMARATE	ACTIVE INGREDIENT	2S3PL1B6UJ	SEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]	10
QUETIAPINE	ACTIVE MOIETY	BGL0JSY5SI	SEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]	10
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]	10
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]	10
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]	10
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]	10
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]	10
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	SEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]	10
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	SEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]	10
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]	10
WATER	INACTIVE INGREDIENT	059QF0KO0R	SEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64725-0284	SEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]	10	Legacy NDC, 1 package rows	20141110_51927f2e-3d56-4644-a6a8-40e0b9a5b579.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
895670	QUEtiapine fumarate 150 MG 24HR Extended Release Oral Tablet	PSN	51927f2e-3d56-4644-a6a8-40e0b9a5b579	10
721791	QUEtiapine fumarate 200 MG 24HR Extended Release Oral Tablet	PSN	51927f2e-3d56-4644-a6a8-40e0b9a5b579	10
721794	QUEtiapine fumarate 300 MG 24HR Extended Release Oral Tablet	PSN	51927f2e-3d56-4644-a6a8-40e0b9a5b579	10
721796	QUEtiapine fumarate 400 MG 24HR Extended Release Oral Tablet	PSN	51927f2e-3d56-4644-a6a8-40e0b9a5b579	10
853201	QUEtiapine fumarate 50 MG 24HR Extended Release Oral Tablet	PSN	51927f2e-3d56-4644-a6a8-40e0b9a5b579	10
895671	SEROQUEL XR 150 MG 24HR Extended Release Oral Tablet	PSN	51927f2e-3d56-4644-a6a8-40e0b9a5b579	10
721793	SEROQUEL XR 200 MG 24HR Extended Release Oral Tablet	PSN	51927f2e-3d56-4644-a6a8-40e0b9a5b579	10
721795	SEROQUEL XR 300 MG 24HR Extended Release Oral Tablet	PSN	51927f2e-3d56-4644-a6a8-40e0b9a5b579	10
721797	SEROQUEL XR 400 MG 24HR Extended Release Oral Tablet	PSN	51927f2e-3d56-4644-a6a8-40e0b9a5b579	10
853202	SEROQUEL XR 50 MG 24HR Extended Release Oral Tablet	PSN	51927f2e-3d56-4644-a6a8-40e0b9a5b579	10
895671	24 HR quetiapine 150 MG Extended Release Oral Tablet [Seroquel]	SBD	51927f2e-3d56-4644-a6a8-40e0b9a5b579	10
721793	24 HR quetiapine 200 MG Extended Release Oral Tablet [Seroquel]	SBD	51927f2e-3d56-4644-a6a8-40e0b9a5b579	10
721795	24 HR quetiapine 300 MG Extended Release Oral Tablet [Seroquel]	SBD	51927f2e-3d56-4644-a6a8-40e0b9a5b579	10
721797	24 HR quetiapine 400 MG Extended Release Oral Tablet [Seroquel]	SBD	51927f2e-3d56-4644-a6a8-40e0b9a5b579	10
853202	24 HR quetiapine 50 MG Extended Release Oral Tablet [Seroquel]	SBD	51927f2e-3d56-4644-a6a8-40e0b9a5b579	10
895670	24 HR quetiapine 150 MG Extended Release Oral Tablet	SCD	51927f2e-3d56-4644-a6a8-40e0b9a5b579	10
721791	24 HR quetiapine 200 MG Extended Release Oral Tablet	SCD	51927f2e-3d56-4644-a6a8-40e0b9a5b579	10
721794	24 HR quetiapine 300 MG Extended Release Oral Tablet	SCD	51927f2e-3d56-4644-a6a8-40e0b9a5b579	10
721796	24 HR quetiapine 400 MG Extended Release Oral Tablet	SCD	51927f2e-3d56-4644-a6a8-40e0b9a5b579	10
853201	24 HR quetiapine 50 MG Extended Release Oral Tablet	SCD	51927f2e-3d56-4644-a6a8-40e0b9a5b579	10
895671	24 HR Seroquel 150 MG Extended Release Oral Tablet	SY	51927f2e-3d56-4644-a6a8-40e0b9a5b579	10
721793	24 HR Seroquel 200 MG Extended Release Oral Tablet	SY	51927f2e-3d56-4644-a6a8-40e0b9a5b579	10
721795	24 HR Seroquel 300 MG Extended Release Oral Tablet	SY	51927f2e-3d56-4644-a6a8-40e0b9a5b579	10
721797	24 HR Seroquel 400 MG Extended Release Oral Tablet	SY	51927f2e-3d56-4644-a6a8-40e0b9a5b579	10
853202	24 HR Seroquel 50 MG Extended Release Oral Tablet	SY	51927f2e-3d56-4644-a6a8-40e0b9a5b579	10
895670	quetiapine 150 MG (as quetiapine fumarate 173 MG) 24 HR Extended Release Oral Tablet	SY	51927f2e-3d56-4644-a6a8-40e0b9a5b579	10
895670	quetiapine 150 MG 24 HR Extended Release Oral Tablet	SY	51927f2e-3d56-4644-a6a8-40e0b9a5b579	10
721791	quetiapine 200 MG (as quetiapine fumarate 230 MG) 24 HR Extended Release Oral Tablet	SY	51927f2e-3d56-4644-a6a8-40e0b9a5b579	10
721791	quetiapine 200 MG 24 HR Extended Release Oral Tablet	SY	51927f2e-3d56-4644-a6a8-40e0b9a5b579	10
721794	quetiapine 300 MG (as quetiapine fumarate 345 MG) 24 HR Extended Release Oral Tablet	SY	51927f2e-3d56-4644-a6a8-40e0b9a5b579	10
721794	quetiapine 300 MG 24 HR Extended Release Oral Tablet	SY	51927f2e-3d56-4644-a6a8-40e0b9a5b579	10
721796	quetiapine 400 MG (as quetiapine fumarate 461 MG) 24 HR Extended Release Oral Tablet	SY	51927f2e-3d56-4644-a6a8-40e0b9a5b579	10
853201	quetiapine 50 MG (as quetiapine fumarate 58 MG) 24 HR Extended Release Oral Tablet	SY	51927f2e-3d56-4644-a6a8-40e0b9a5b579	10
853201	quetiapine 50 MG 24 HR Extended Release Oral Tablet	SY	51927f2e-3d56-4644-a6a8-40e0b9a5b579	10
895671	Seroquel XR 150 MG (quetiapine fumarate 173 MG) 24 HR Extended Release Oral Tablet	SY	51927f2e-3d56-4644-a6a8-40e0b9a5b579	10
721793	Seroquel XR 200 MG (quetiapine fumarate 230 MG) 24 HR Extended Release Oral Tablet	SY	51927f2e-3d56-4644-a6a8-40e0b9a5b579	10
721795	Seroquel XR 300 MG (quetiapine fumarate 345 MG) 24 HR Extended Release Oral Tablet	SY	51927f2e-3d56-4644-a6a8-40e0b9a5b579	10
721797	Seroquel XR 400 MG (quetiapine fumarate 461 MG) 24 HR Extended Release Oral Tablet	SY	51927f2e-3d56-4644-a6a8-40e0b9a5b579	10
853202	Seroquel XR 50 MG (quetiapine fumarate 58 MG) 24 HR Extended Release Oral Tablet	SY	51927f2e-3d56-4644-a6a8-40e0b9a5b579	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
64725-0284-1	64725028401	60 in 1 BOTTLE	Historical