Quetiapine Fumarate

Product NDC: 49884-807
11-digit product format: 498840807
Labeler code: 49884
Product ID: 49884-807_440f6694-a119-4982-b5ee-fd7a00d0c77a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Quetiapine fumarate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Par Pharmaceutical Inc.
Application: NDA022047
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2016-11-01
Marketing end: 2019-09-30
Substance: QUETIAPINE FUMARATE
Active strength: 200 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
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	49884-807		D	Discontinued by firm		2026-08-03
excluded package	package	49884-807	49884-807-02	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	49884-807-02	`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	49884-807-02	`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	49884-807-02	`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	49884-807-02	`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	49884-807-02	`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	49884-807-02	`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	49884-807-02	`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	49884-807-02	`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	49884-807-02	`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	49884-807-02	`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	49884-807-02	`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	49884-807-02	`557ba5c1ecfa…`	`9c80585c8c6e…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49884-807-02	EA - Each	49884-807	7406c746-5d50-4372-b151-17475ace0c1c	1	2016-12-07

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Quetiapine Fumarate Extended Release	Par Pharmaceutical Inc. \| AstraZeneca PLC	2019-10-29	HUMAN PRESCRIPTION DRUG LABEL	7