SEROQUEL

Product NDC: 70518-2166
11-digit product format: 705182166
Labeler code: 70518
Product ID: 70518-2166_973541d8-2b59-c0fa-e053-2a95a90a9523
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Quetiapine fumarate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: NDA020639
Marketing category: NDA
Marketing start: 2019-06-28
Marketing end: 0000-00-00
Substance: QUETIAPINE FUMARATE
Active strength: 300 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	70518-2166		D	Discontinued by firm		2026-08-03
excluded package	package	70518-2166	70518-2166-0	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 · 24 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	70518-2166-0	`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	70518-2166-0	`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	70518-2166-0	`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	70518-2166-0	`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	70518-2166-0	`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	70518-2166-0	`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	70518-2166-0	`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	70518-2166-0	`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	70518-2166-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-2166-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-2166-0	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70518-2166-0	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020639-001	SEROQUEL	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	1997-09-26
N020639-002	SEROQUEL	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	RLD	1997-09-26
N020639-003	SEROQUEL	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	RLD	1997-09-26
N020639-004	SEROQUEL	QUETIAPINE FUMARATE	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-12-20
N020639-005	SEROQUEL	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2000-07-26
N020639-006	SEROQUEL	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	RLD	2005-10-04
N020639-007	SEROQUEL	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	RLD	2005-10-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020639-001	AB
N020639-002	AB
N020639-003	AB
N020639-005	AB
N020639-006	AB
N020639-007	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 8 · 287 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	N020639-001	SEROQUEL	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	1997-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020639-002	SEROQUEL	EQ 100MG BASE	TABLET / ORAL	AB	RLD	1997-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020639-003	SEROQUEL	EQ 200MG BASE	TABLET / ORAL	AB	RLD	1997-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020639-004	SEROQUEL	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020639-005	SEROQUEL	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2000-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020639-006	SEROQUEL	EQ 400MG BASE	TABLET / ORAL	AB	RLD	2005-10-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020639-007	SEROQUEL	EQ 50MG BASE	TABLET / ORAL	AB	RLD	2005-10-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020639-001	SEROQUEL	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	1997-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020639-002	SEROQUEL	EQ 100MG BASE	TABLET / ORAL	AB	RLD	1997-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020639-003	SEROQUEL	EQ 200MG BASE	TABLET / ORAL	AB	RLD	1997-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020639-004	SEROQUEL	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020639-005	SEROQUEL	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2000-07-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020639-006	SEROQUEL	EQ 400MG BASE	TABLET / ORAL	AB	RLD	2005-10-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020639-007	SEROQUEL	EQ 50MG BASE	TABLET / ORAL	AB	RLD	2005-10-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020639-001	SEROQUEL	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	1997-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020639-002	SEROQUEL	EQ 100MG BASE	TABLET / ORAL	AB	RLD	1997-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020639-003	SEROQUEL	EQ 200MG BASE	TABLET / ORAL	AB	RLD	1997-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020639-004	SEROQUEL	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020639-005	SEROQUEL	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2000-07-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020639-006	SEROQUEL	EQ 400MG BASE	TABLET / ORAL	AB	RLD	2005-10-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020639-007	SEROQUEL	EQ 50MG BASE	TABLET / ORAL	AB	RLD	2005-10-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020639-001	SEROQUEL	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	1997-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020639-002	SEROQUEL	EQ 100MG BASE	TABLET / ORAL	AB	RLD	1997-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020639-003	SEROQUEL	EQ 200MG BASE	TABLET / ORAL	AB	RLD	1997-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020639-004	SEROQUEL	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020639-005	SEROQUEL	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2000-07-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020639-006	SEROQUEL	EQ 400MG BASE	TABLET / ORAL	AB	RLD	2005-10-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020639-007	SEROQUEL	EQ 50MG BASE	TABLET / ORAL	AB	RLD	2005-10-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020639-001	SEROQUEL	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	1997-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020639-002	SEROQUEL	EQ 100MG BASE	TABLET / ORAL	AB	RLD	1997-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020639-003	SEROQUEL	EQ 200MG BASE	TABLET / ORAL	AB	RLD	1997-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020639-004	SEROQUEL	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020639-005	SEROQUEL	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2000-07-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020639-006	SEROQUEL	EQ 400MG BASE	TABLET / ORAL	AB	RLD	2005-10-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020639-007	SEROQUEL	EQ 50MG BASE	TABLET / ORAL	AB	RLD	2005-10-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020639-001	SEROQUEL	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	1997-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020639-002	SEROQUEL	EQ 100MG BASE	TABLET / ORAL	AB	RLD	1997-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020639-003	SEROQUEL	EQ 200MG BASE	TABLET / ORAL	AB	RLD	1997-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020639-004	SEROQUEL	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020639-005	SEROQUEL	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2000-07-26	`03ed91905a0d…`

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	N020639-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020639-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020639-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020639-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020639-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020639-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020639-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020639-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020639-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020639-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020639-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020639-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020639-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020639-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020639-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020639-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020639-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020639-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020639-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020639-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020639-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020639-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020639-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020639-007	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020639-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020639-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020639-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020639-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020639-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020639-007	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020639-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020639-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020639-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020639-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020639-006	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020639-007	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020639-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020639-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020639-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020639-005	AB	1	`2680178bc6a6…`

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	QUETIAPINE	H2-Pharma, LLC	8ae62aaf-f8c5-417f-baac-0098369ca322	2026-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020639 application number: NDA020639
SEROQUEL	QUETIAPINE	AstraZeneca Pharmaceuticals LP	0584dda8-bc3c-48fe-1a90-79608f78e8a0	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020639 application number: NDA020639