Quetiapine Fumarate

Product NDC: 51407-075
11-digit product format: 514070075
Labeler code: 51407
Product ID: 51407-075_a2b7d516-721c-608d-e053-2995a90adbee
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: quetiapine fumarate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Golden State Medical Supply
Application: ANDA208947
Marketing category: ANDA
Marketing start: 2017-11-29
Marketing end: 0000-00-00
Substance: QUETIAPINE FUMARATE
Active strength: 200 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
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	51407-075		D	Discontinued by firm		2026-10-15
excluded package	package	51407-075	51407-075-60	D	Discontinued by firm		2026-10-15

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 · 4 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	51407-075-60	`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	51407-075-60	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A208947-001	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29
A208947-002	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29
A208947-003	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29
A208947-004	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29
A208947-005	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
A208947-001	AB
A208947-002	AB
A208947-003	AB
A208947-004	AB
A208947-005	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	A208947-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A208947-002	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A208947-003	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A208947-004	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A208947-005	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A208947-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208947-002	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208947-003	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208947-004	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208947-005	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208947-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208947-002	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208947-003	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208947-004	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208947-005	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208947-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208947-002	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208947-003	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208947-004	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208947-005	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	A208947-001	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	A208947-002	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	A208947-003	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	A208947-004	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	A208947-005	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208947-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208947-002	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208947-003	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208947-004	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208947-005	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	A208947-001	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	A208947-002	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	A208947-003	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	A208947-004	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	A208947-005	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	A208947-001	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	A208947-002	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	A208947-003	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	A208947-004	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	A208947-005	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A208947-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A208947-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A208947-003	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A208947-004	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A208947-005	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208947-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A208947-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A208947-003	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A208947-004	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A208947-005	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208947-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208947-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208947-003	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208947-004	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208947-005	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208947-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208947-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208947-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208947-004	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208947-005	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51407-075-60	EA - Each	51407-075	1aa6486a-9bcf-475c-8587-ba1193ac7d23	1	2018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51407-075	QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	8	Legacy NDC	20241228_7b2218ae-a310-22d0-e053-2a91aa0a769d.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 FUMARATE	Ingenus Pharmaceuticals, LLC	8923c441-c9aa-4b30-89d7-dbaaa7f66656	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208947 application number: ANDA208947

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
51407-075-60	51407007560	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (51407-075-60)	2017-11-29	0000-00-00	No	No	Current