QUETIAPINE FUMARATE

Product NDC: 68001-515
11-digit product format: 680010515
Labeler code: 68001
Product ID: 68001-515_e17da200-0b22-7fcb-e053-2995a90a6c42
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: QUETIAPINE FUMARATE
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Bluepoint Laboratories
Application: ANDA090681
Marketing category: ANDA
Marketing start: 2021-08-31
Marketing end: 0000-00-00
Substance: QUETIAPINE FUMARATE
Active strength: 400 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	68001-515		D	Discontinued by firm		2026-08-10
excluded package	package	68001-515	68001-515-06	D	Discontinued by firm		2026-08-10

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090681-001	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09
A090681-002	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09
A090681-003	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09
A090681-004	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A090681-001	AB
A090681-002	AB
A090681-003	AB
A090681-004	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 5 · 164 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
2026-02-19 14:30 UTC	2026-02	A090681-001	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090681-002	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090681-003	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090681-004	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090681-001	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090681-002	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090681-003	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090681-004	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090681-001	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090681-002	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090681-003	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090681-004	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090681-001	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090681-002	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090681-003	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090681-004	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090681-001	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090681-002	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090681-003	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090681-004	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090681-001	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090681-002	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090681-003	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090681-004	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090681-001	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090681-002	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090681-003	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090681-004	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090681-001	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090681-002	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090681-003	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090681-004	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090681-001	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090681-002	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090681-003	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090681-004	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090681-001	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090681-002	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090681-003	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090681-004	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-01	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A090681-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090681-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090681-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090681-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090681-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090681-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090681-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090681-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090681-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090681-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090681-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090681-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090681-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090681-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090681-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090681-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090681-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090681-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090681-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090681-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090681-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090681-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090681-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090681-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090681-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090681-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090681-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090681-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090681-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090681-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090681-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090681-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090681-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090681-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090681-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090681-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090681-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090681-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090681-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090681-004	AB	1	`d06236e962d9…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68001-515-06	EA - Each	68001-515	d5932cba-0d1f-4696-8503-2733c0790131	1	2021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68001-515	QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	3	Legacy NDC	20250322_0df19623-5cd5-4544-b02a-84ec7fddf87d.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	Accord Healthcare Inc.	3ffe0294-3959-2755-e054-00144ff8d46c	2025-11-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090681 application number: ANDA090681
Quetiapine Fumarate ER	QUETIAPINE FUMARATE ER	Direct_Rx	fd11db2d-364d-9bd6-e053-6394a90ade0b	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090681 application number: ANDA090681
Quetiapine Fumarate ER	QUETIAPINE FUMARATE ER	Direct_Rx	fd17163f-a308-5c9a-e053-6294a90a2ae6	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090681 application number: ANDA090681
Quetiapine Fumarate ER	QUETIAPINE FUMARATE ER	Direct_Rx	fd12e3cb-8b9b-4ea0-e053-6294a90a4e7a	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090681 application number: ANDA090681

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
68001-515-06	68001051506	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-515-06)	2021-08-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
QUETIAPINE FUMARATE	Bluepoint Laboratories \| Intas Pharmaceuticals Limited	2025-03-13	HUMAN PRESCRIPTION DRUG LABEL	3