Quetiapine fumarate

Product NDC: 68788-7195
11-digit product format: 687887195
Labeler code: 68788
Product ID: 68788-7195_256c58be-db83-4482-b26f-680a16c293f0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Quetiapine fumarate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA203359
Marketing category: ANDA
Marketing start: 2018-07-19
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: 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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68788-7195		D	Discontinued by firm	2026-09-14
excluded package	package	68788-7195	68788-7195-1	D	Discontinued by firm	2026-09-14
excluded package	package	68788-7195	68788-7195-3	D	Discontinued by firm	2026-09-14
excluded package	package	68788-7195	68788-7195-6	D	Discontinued by firm	2026-09-14
excluded package	package	68788-7195	68788-7195-8	D	Discontinued by firm	2026-09-14
excluded package	package	68788-7195	68788-7195-9	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 2 · 72 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	68788-7195-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-7195-8	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-7195-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-7195-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-7195-9	`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	68788-7195-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-7195-8	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-7195-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-7195-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-7195-9	`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	68788-7195-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-7195-8	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-7195-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-7195-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-7195-9	`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	68788-7195-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-7195-8	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-7195-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-7195-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-7195-9	`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	68788-7195-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-7195-8	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-7195-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-7195-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-7195-9	`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	68788-7195-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-7195-8	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-7195-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-7195-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-7195-9	`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	68788-7195-6	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-7195-8	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-7195-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-7195-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-7195-9	`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	68788-7195-6	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-7195-8	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-7195-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-7195-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-7195-9	`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	68788-7195-6	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-7195-8	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-7195-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-7195-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-7195-9	`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	68788-7195-6	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-7195-8	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-7195-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-7195-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-7195-9	`ad56d346431e…`	`cc804d4bbf1e…`

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
A203359-001	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-05-17
A203359-002	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-05-17
A203359-003	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-05-17
A203359-004	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2016-05-17
A203359-005	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2016-05-17
A203359-006	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-05-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A203359-001	AB
A203359-002	AB
A203359-003	AB
A203359-004	AB
A203359-005	AB
A203359-006	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	A203359-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203359-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203359-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203359-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2016-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203359-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2016-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203359-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-05-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203359-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203359-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203359-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203359-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2016-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203359-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2016-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203359-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-05-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203359-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203359-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203359-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203359-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2016-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203359-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2016-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203359-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-05-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203359-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203359-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203359-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203359-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2016-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203359-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2016-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203359-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-05-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203359-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203359-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203359-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203359-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2016-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203359-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2016-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203359-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-05-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203359-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203359-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203359-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203359-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2016-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203359-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2016-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203359-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-05-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203359-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203359-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203359-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203359-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2016-05-17	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 258 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	A203359-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203359-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203359-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203359-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203359-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203359-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203359-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203359-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203359-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203359-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203359-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203359-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203359-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203359-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203359-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203359-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203359-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203359-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203359-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203359-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203359-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203359-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203359-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203359-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203359-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203359-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203359-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203359-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203359-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203359-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203359-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203359-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203359-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203359-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203359-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203359-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203359-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203359-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203359-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203359-004	AB	1	`b8a1b40f171c…`

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
68788-7195-1	EA - Each	68788-7195	25159a46-7583-43ce-a015-3c6e1db3ee7b	1	2018-09-05
68788-7195-3	EA - Each	68788-7195	b42d06eb-c572-4c37-9f83-e7897a59afaa	1	2018-09-05
68788-7195-6	EA - Each	68788-7195	5db4d6b9-64ef-4a2e-83a5-8b1989a0391a	1	2018-09-05
68788-7195-8	EA - Each	68788-7195	b2052329-b1c7-494d-b14f-9c38472a5702	1	2018-09-05
68788-7195-9	EA - Each	68788-7195	bfdf5384-eb39-4eb3-b684-d23e2cf73164	1	2018-09-05

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
Quetiapine fumarate	QUETIAPINE FUMARATE	Bryant Ranch Prepack	293a9857-d138-4583-abc9-35b75660e324	2024-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203359 application number: ANDA203359
Quetiapine fumarate	QUETIAPINE FUMARATE	Macleods Pharmaceuticals Limited	531cbe20-dff2-4983-9788-4543079f83ff	2023-03-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203359 application number: ANDA203359

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
68788-7195-1	68788719501	100 TABLET, FILM COATED in 1 BOTTLE (68788-7195-1)	2018-07-19	0000-00-00	No	No	Current
68788-7195-3	68788719503	30 TABLET, FILM COATED in 1 BOTTLE (68788-7195-3)	2018-07-19	0000-00-00	No	No	Current
68788-7195-6	68788719506	60 TABLET, FILM COATED in 1 BOTTLE (68788-7195-6)	2018-07-19	0000-00-00	No	No	Current
68788-7195-8	68788719508	120 TABLET, FILM COATED in 1 BOTTLE (68788-7195-8)	2018-07-19	0000-00-00	No	No	Current
68788-7195-9	68788719509	90 TABLET, FILM COATED in 1 BOTTLE (68788-7195-9)	2018-07-19	0000-00-00	No	No	Current