Quetiapine fumarate

Product NDC: 68788-7950
Requested package NDC: 68788-7950-3
11-digit product format: 687887950
Labeler code: 68788
Product ID: 68788-7950_7517a684-bf30-47aa-8218-87406892cb4d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Quetiapine fumarate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA201190
Marketing category: ANDA
Marketing start: 2021-07-08
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: 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68788-7950	68788-7950-3	D	Discontinued by firm		2026-09-14

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-7950	68788-7950-3	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A201190-001	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL		2012-03-27
A201190-002	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27
A201190-003	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27
A201190-004	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL		2012-03-27
A201190-005	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27
A201190-006	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL		2012-03-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A201190-002	AB
A201190-003	AB
A201190-005	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 7 · 258 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
2026-09-14 22:38:34	2026-08	A201190-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL		2012-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201190-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201190-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201190-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL		2012-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201190-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201190-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL		2012-03-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201190-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL		2012-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201190-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201190-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201190-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL		2012-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201190-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201190-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL		2012-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201190-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201190-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201190-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201190-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL		2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201190-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201190-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201190-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201190-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201190-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201190-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL		2012-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201190-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201190-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201190-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201190-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201190-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201190-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201190-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201190-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201190-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201190-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201190-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201190-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201190-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201190-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201190-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201190-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201190-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201190-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 247 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A201190-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201190-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201190-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201190-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201190-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201190-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201190-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201190-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201190-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201190-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201190-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201190-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201190-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201190-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201190-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201190-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201190-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201190-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201190-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201190-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201190-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201190-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201190-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201190-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201190-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201190-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201190-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201190-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201190-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201190-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201190-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201190-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201190-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201190-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201190-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201190-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201190-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201190-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201190-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201190-006	AB	1	`03ed91905a0d…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-7950-1	EA - Each	68788-7950	36666766-2f78-4df2-80ff-158e1eb492b6	1	2021-08-05
68788-7950-3	EA - Each	68788-7950	e4981d3e-158c-4fe4-b8d9-a8380d4579eb	1	2021-08-05
68788-7950-6	EA - Each	68788-7950	69028112-1da5-4b52-8835-e8f6f7f4337e	1	2021-08-05
68788-7950-8	EA - Each	68788-7950	2845bf52-2000-4b28-95d5-11a99e768a6f	1	2021-08-05
68788-7950-9	EA - Each	68788-7950	afd5205b-b560-46a9-bc92-4469f3bfe6ac	1	2021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-7950	QUETIAPINE FUMARATE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]	4	Legacy NDC	20240806_534732b5-925d-4476-b6d8-12ca403e6d00.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Quetiapine fumarate	QUETIAPINE FUMARATE	Bryant Ranch Prepack	c52a9bff-8a03-44f5-9128-799c7dca0467	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201190 application number: ANDA201190
Quetiapine fumarate	QUETIAPINE FUMARATE	Bryant Ranch Prepack	3eb39b4e-4c79-43b9-a30e-b4221c0e2bd2	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201190 application number: ANDA201190
Quetiapine fumarate	QUETIAPINE FUMARATE	Sun Pharmaceutical Industries, Inc.	ffe52b98-9872-48c1-90fd-8fcd37c3432f	2026-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201190 application number: ANDA201190
Quetiapine fumarate	QUETIAPINE FUMARATE	Coupler LLC	258eac65-69ed-404f-e063-6394a90a19ef	2025-05-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201190 application number: ANDA201190
Quetiapine fumarate	QUETIAPINE FUMARATE	Bryant Ranch Prepack	9a024071-e620-48e8-9f22-d4cda5dc5ab1	2025-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201190 application number: ANDA201190

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
68788-7950-3	68788795003	30 TABLET, FILM COATED in 1 BOTTLE (68788-7950-3)	2021-07-08	0000-00-00	No	No	Current