Quetiapine Fumarate

Product NDC: 50090-5451
Requested package NDC: 50090-5451-0
11-digit product format: 500905451
Labeler code: 50090
Product ID: 50090-5451_5bde79bf-b7c6-4fbd-a27a-dcd013986d0a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Quetiapine
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA207655
Marketing category: ANDA
Marketing start: 2017-11-29
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: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-5451	50090-5451-0	I	Inactivated by FDA		2026-11-06

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	Approval date
A207655-001	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29
A207655-002	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29
A207655-003	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29
A207655-004	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29
A207655-005	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207655-001	AB
A207655-002	AB
A207655-003	AB
A207655-004	AB
A207655-005	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 · 220 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
2026-10-15 13:18:30	2026-09	A207655-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207655-002	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207655-003	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207655-004	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207655-005	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A207655-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207655-002	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207655-003	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207655-004	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207655-005	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207655-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207655-002	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207655-003	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207655-004	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207655-005	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207655-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207655-002	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207655-003	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207655-004	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207655-005	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207655-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207655-002	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207655-003	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207655-004	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207655-005	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207655-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207655-002	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207655-003	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207655-004	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207655-005	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207655-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207655-002	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207655-003	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207655-004	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207655-005	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207655-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207655-002	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207655-003	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207655-004	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207655-005	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 220 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A207655-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207655-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207655-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207655-004	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207655-005	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A207655-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207655-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207655-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207655-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207655-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207655-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207655-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207655-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207655-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207655-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207655-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207655-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207655-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207655-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207655-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207655-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207655-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207655-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207655-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207655-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207655-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207655-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207655-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207655-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207655-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207655-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207655-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207655-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207655-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207655-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207655-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207655-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207655-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207655-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207655-005	AB	1	`b8a1b40f171c…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
50090-5451-0	2023-01-30	C162847	48780-1	f386c649-d3e6-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use QUETIAPINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for QUETIAPINE EXTENDED-RELEASE TABLETS. QUETIAPINE 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
50090-5451-0	Quetiapine Fumarate	60 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	60		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-5451	QUETIAPINE FUMARATE (QUETIAPINE) TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]	1	Legacy NDC, 1 package rows	20210304_a83f2f2e-0e59-482c-90c8-2fd771f04d74.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Quetiapine Fumarate	QUETIAPINE	Aurobindo Pharma Limited	6562eb60-0d70-4909-bd07-88d5c9241516	2025-09-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207655 application number: ANDA207655

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2S3PL1B6UJ	QUETIAPINE FUMARATE	111974-72-2	QUETIAPINE FUMARATE
BGL0JSY5SI	QUETIAPINE	111974-69-7	Quetiapine

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	a83f2f2e-0e59-482c-90c8-2fd771f04d74	1
721794	24 HR quetiapine 300 MG Extended Release Oral Tablet	SCD	a83f2f2e-0e59-482c-90c8-2fd771f04d74	1
721794	quetiapine 300 MG (as quetiapine fumarate 345 MG) 24 HR Extended Release Oral Tablet	SY	a83f2f2e-0e59-482c-90c8-2fd771f04d74	1
721794	quetiapine 300 MG 24 HR Extended Release Oral Tablet	SY	a83f2f2e-0e59-482c-90c8-2fd771f04d74	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-5451-0	50090545100	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-5451-0)	2021-01-25	0000-00-00	No	No	Current