quetiapine fumarate

Product NDC: 60505-3135
11-digit product format: 605053135
Labeler code: 60505
Product ID: 60505-3135_bdf36658-c472-9290-51e8-289072ae3157
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: quetiapine fumarate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Apotex Corp.
Application: ANDA090960
Marketing category: ANDA
Marketing start: 2012-03-27
Marketing end: 2021-06-30
Substance: QUETIAPINE FUMARATE
Active strength: 200 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
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	60505-3135		D	Discontinued by firm	2026-10-05
excluded package	package	60505-3135	60505-3135-0	D	Discontinued by firm	2026-10-05
excluded package	package	60505-3135	60505-3135-1	D	Discontinued by firm	2026-10-05
excluded package	package	60505-3135	60505-3135-3	D	Discontinued by firm	2026-10-05
excluded package	package	60505-3135	60505-3135-5	D	Discontinued by firm	2026-10-05
excluded package	package	60505-3135	60505-3135-8	D	Discontinued by firm	2026-10-05

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	60505-3135-8	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	60505-3135-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	60505-3135-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	60505-3135-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	60505-3135-1	`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	60505-3135-8	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	60505-3135-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	60505-3135-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	60505-3135-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	60505-3135-1	`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	60505-3135-8	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	60505-3135-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	60505-3135-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	60505-3135-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	60505-3135-1	`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	60505-3135-8	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	60505-3135-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	60505-3135-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	60505-3135-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	60505-3135-1	`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	60505-3135-8	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	60505-3135-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	60505-3135-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	60505-3135-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	60505-3135-1	`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	60505-3135-8	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	60505-3135-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	60505-3135-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	60505-3135-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	60505-3135-1	`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	60505-3135-8	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	60505-3135-5	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	60505-3135-0	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	60505-3135-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	60505-3135-1	`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	60505-3135-8	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	60505-3135-5	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	60505-3135-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	60505-3135-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	60505-3135-1	`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	60505-3135-8	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	60505-3135-5	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	60505-3135-0	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	60505-3135-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	60505-3135-1	`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	60505-3135-8	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	60505-3135-5	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	60505-3135-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	60505-3135-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	60505-3135-1	`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
A090960-001	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27
A090960-002	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27
A090960-003	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27
A090960-004	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27
A090960-005	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27
A090960-006	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090960-001	AB
A090960-002	AB
A090960-003	AB
A090960-004	AB
A090960-005	AB
A090960-006	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	A090960-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090960-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090960-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090960-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090960-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090960-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090960-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090960-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090960-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090960-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090960-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090960-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090960-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090960-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090960-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090960-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090960-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090960-006	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	A090960-001	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	A090960-002	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	A090960-003	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	A090960-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090960-005	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	A090960-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090960-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090960-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090960-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090960-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090960-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090960-006	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	A090960-001	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	A090960-002	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	A090960-003	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	A090960-004	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	A090960-005	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	A090960-006	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	A090960-001	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	A090960-002	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	A090960-003	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	A090960-004	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 · 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	A090960-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090960-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090960-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090960-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090960-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090960-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090960-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090960-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090960-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090960-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090960-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090960-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090960-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090960-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090960-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090960-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090960-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090960-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090960-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090960-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090960-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090960-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090960-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090960-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090960-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090960-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090960-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090960-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090960-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090960-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090960-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090960-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090960-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090960-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090960-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090960-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090960-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090960-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090960-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090960-004	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
60505-3135-1	EA - Each	60505-3135	0ad89ef6-f67e-4852-a5af-beccbb7c2903	1	2012-07-24
60505-3135-8	EA - Each	60505-3135	cc6f48d2-6f11-4fa0-a8dc-b8ed1f5b1d85	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
QUETIAPINE FUMARATE	ACTIVE INGREDIENT	2S3PL1B6UJ	QUETIAPINE FUMARATE TABLET, FILM COATED [APOTEX CORP.]	5
QUETIAPINE	ACTIVE MOIETY	BGL0JSY5SI	QUETIAPINE FUMARATE TABLET, FILM COATED [APOTEX CORP.]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	QUETIAPINE FUMARATE TABLET, FILM COATED [APOTEX CORP.]	5
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	QUETIAPINE FUMARATE TABLET, FILM COATED [APOTEX CORP.]	5
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	QUETIAPINE FUMARATE TABLET, FILM COATED [APOTEX CORP.]	5
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	QUETIAPINE FUMARATE TABLET, FILM COATED [APOTEX CORP.]	5
FUMARIC ACID	INACTIVE INGREDIENT	88XHZ13131	QUETIAPINE FUMARATE TABLET, FILM COATED [APOTEX CORP.]	5
Hydroxypropyl Cellulose (Type L)	INACTIVE INGREDIENT	UKE75GEA7F	QUETIAPINE FUMARATE TABLET, FILM COATED [APOTEX CORP.]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	QUETIAPINE FUMARATE TABLET, FILM COATED [APOTEX CORP.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	QUETIAPINE FUMARATE TABLET, FILM COATED [APOTEX CORP.]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	QUETIAPINE FUMARATE TABLET, FILM COATED [APOTEX CORP.]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	QUETIAPINE FUMARATE TABLET, FILM COATED [APOTEX CORP.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	QUETIAPINE FUMARATE TABLET, FILM COATED [APOTEX CORP.]	5

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
60505-3135-8	60505313508	1000 TABLET, FILM COATED in 1 BOTTLE (60505-3135-8)	2012-03-27	2021-06-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
quetiapine fumarate	Golden State Medical Supply, Inc.	2021-02-04	HUMAN PRESCRIPTION DRUG LABEL	5
quetiapine fumarate	REMEDYREPACK INC.	2019-08-12	HUMAN PRESCRIPTION DRUG LABEL	3
quetiapine fumarate	Apotex Corp. \| Apotex Inc.	2019-01-09	HUMAN PRESCRIPTION DRUG LABEL	11
quetiapine fumarate	A-S Medication Solutions	2018-03-30	HUMAN PRESCRIPTION DRUG LABEL	9