SEROQUEL

Product NDC: 21695-120
11-digit product format: 216950120
Labeler code: 21695
Product ID: 21695-120_3dc79540-2f24-4920-99cd-ef6482f68eb2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Quetiapine fumarate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Rebel Distributors Corp
Application: NDA020639
Marketing category: NDA
Marketing start: 2010-06-01
Marketing end: 0000-00-00
Substance: QUETIAPINE FUMARATE
Active strength: 200 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
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	21695-120		I	Inactivated by FDA		2026-08-03
excluded package	package	21695-120	21695-120-02	I	Inactivated by FDA		2026-08-03

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 · 44 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	21695-120-02	`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	21695-120-02	`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	21695-120-02	`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	21695-120-02	`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	21695-120-02	`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	21695-120-02	`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	21695-120-02	`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	21695-120-02	`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	21695-120-02	`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	21695-120-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-120-02	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-120-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-120-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-120-02	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-120-02	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-120-02	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-120-02	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-120-02	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-120-02	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-120-02	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	21695-120-02	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	21695-120-02	`110d247fa046…`	`a55b01930146…`

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

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020639-001	SEROQUEL	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	1997-09-26
N020639-002	SEROQUEL	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	RLD	1997-09-26
N020639-003	SEROQUEL	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	RLD	1997-09-26
N020639-004	SEROQUEL	QUETIAPINE FUMARATE	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-12-20
N020639-005	SEROQUEL	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2000-07-26
N020639-006	SEROQUEL	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	RLD	2005-10-04
N020639-007	SEROQUEL	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	RLD	2005-10-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020639-001	AB
N020639-002	AB
N020639-003	AB
N020639-005	AB
N020639-006	AB
N020639-007	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 8 · 287 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020639-001	SEROQUEL	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	1997-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020639-002	SEROQUEL	EQ 100MG BASE	TABLET / ORAL	AB	RLD	1997-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020639-003	SEROQUEL	EQ 200MG BASE	TABLET / ORAL	AB	RLD	1997-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020639-004	SEROQUEL	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020639-005	SEROQUEL	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2000-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020639-006	SEROQUEL	EQ 400MG BASE	TABLET / ORAL	AB	RLD	2005-10-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020639-007	SEROQUEL	EQ 50MG BASE	TABLET / ORAL	AB	RLD	2005-10-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020639-001	SEROQUEL	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	1997-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020639-002	SEROQUEL	EQ 100MG BASE	TABLET / ORAL	AB	RLD	1997-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020639-003	SEROQUEL	EQ 200MG BASE	TABLET / ORAL	AB	RLD	1997-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020639-004	SEROQUEL	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020639-005	SEROQUEL	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2000-07-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020639-006	SEROQUEL	EQ 400MG BASE	TABLET / ORAL	AB	RLD	2005-10-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020639-007	SEROQUEL	EQ 50MG BASE	TABLET / ORAL	AB	RLD	2005-10-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020639-001	SEROQUEL	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	1997-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020639-002	SEROQUEL	EQ 100MG BASE	TABLET / ORAL	AB	RLD	1997-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020639-003	SEROQUEL	EQ 200MG BASE	TABLET / ORAL	AB	RLD	1997-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020639-004	SEROQUEL	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020639-005	SEROQUEL	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2000-07-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020639-006	SEROQUEL	EQ 400MG BASE	TABLET / ORAL	AB	RLD	2005-10-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020639-007	SEROQUEL	EQ 50MG BASE	TABLET / ORAL	AB	RLD	2005-10-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020639-001	SEROQUEL	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	1997-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020639-002	SEROQUEL	EQ 100MG BASE	TABLET / ORAL	AB	RLD	1997-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020639-003	SEROQUEL	EQ 200MG BASE	TABLET / ORAL	AB	RLD	1997-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020639-004	SEROQUEL	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020639-005	SEROQUEL	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2000-07-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020639-006	SEROQUEL	EQ 400MG BASE	TABLET / ORAL	AB	RLD	2005-10-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020639-007	SEROQUEL	EQ 50MG BASE	TABLET / ORAL	AB	RLD	2005-10-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020639-001	SEROQUEL	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	1997-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020639-002	SEROQUEL	EQ 100MG BASE	TABLET / ORAL	AB	RLD	1997-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020639-003	SEROQUEL	EQ 200MG BASE	TABLET / ORAL	AB	RLD	1997-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020639-004	SEROQUEL	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020639-005	SEROQUEL	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2000-07-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020639-006	SEROQUEL	EQ 400MG BASE	TABLET / ORAL	AB	RLD	2005-10-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020639-007	SEROQUEL	EQ 50MG BASE	TABLET / ORAL	AB	RLD	2005-10-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020639-001	SEROQUEL	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	1997-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020639-002	SEROQUEL	EQ 100MG BASE	TABLET / ORAL	AB	RLD	1997-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020639-003	SEROQUEL	EQ 200MG BASE	TABLET / ORAL	AB	RLD	1997-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020639-004	SEROQUEL	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020639-005	SEROQUEL	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2000-07-26	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 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	N020639-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020639-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020639-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020639-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020639-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020639-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020639-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020639-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020639-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020639-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020639-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020639-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020639-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020639-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020639-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020639-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020639-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020639-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020639-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020639-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020639-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020639-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020639-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020639-007	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020639-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020639-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020639-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020639-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020639-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020639-007	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020639-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020639-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020639-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020639-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020639-006	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020639-007	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020639-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020639-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020639-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020639-005	AB	1	`2680178bc6a6…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5ef42f82-f087-0d2c-105f-f791ca69210e	Product name	8	20250729
21205abd-8c89-4943-9f85-908f3d4fc3bb	Product name	5	20230501

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-120-02	2019-09-24	C162847	48780-1	934fe258-4b4e-48b1-e053-8cdaa90a720a	These highlights do not include all the information needed to use SEROQUEL safely and effectively. See full prescribing information for SEROQUEL. SEROQUEL ® (quetiapine fumarate) Tablets Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-120-02	SEROQUEL	15 in 1 BOTTLE	TABLET, FILM COATED	15		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
QUETIAPINE FUMARATE	ACTIVE INGREDIENT	2S3PL1B6UJ	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
QUETIAPINE	ACTIVE MOIETY	BGL0JSY5SI	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-120	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20110622_3dc79540-2f24-4920-99cd-ef6482f68eb2.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SEROQUEL	QUETIAPINE	H2-Pharma, LLC	8ae62aaf-f8c5-417f-baac-0098369ca322	2026-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020639 application number: NDA020639
SEROQUEL	QUETIAPINE	AstraZeneca Pharmaceuticals LP	0584dda8-bc3c-48fe-1a90-79608f78e8a0	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020639 application number: NDA020639

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312743	QUEtiapine fumarate 100 MG Oral Tablet	PSN	3dc79540-2f24-4920-99cd-ef6482f68eb2	1
317174	QUEtiapine fumarate 200 MG Oral Tablet	PSN	3dc79540-2f24-4920-99cd-ef6482f68eb2	1
312744	QUEtiapine fumarate 25 MG Oral Tablet	PSN	3dc79540-2f24-4920-99cd-ef6482f68eb2	1
616487	QUEtiapine fumarate 50 MG Oral Tablet	PSN	3dc79540-2f24-4920-99cd-ef6482f68eb2	1
153639	SEROquel 100 MG Oral Tablet	PSN	3dc79540-2f24-4920-99cd-ef6482f68eb2	1
153640	SeroQUEL 200 MG Oral Tablet	PSN	3dc79540-2f24-4920-99cd-ef6482f68eb2	1
153638	SeroQUEL 25 MG Oral Tablet	PSN	3dc79540-2f24-4920-99cd-ef6482f68eb2	1
616489	SeroQUEL 50 MG Oral Tablet	PSN	3dc79540-2f24-4920-99cd-ef6482f68eb2	1
153639	quetiapine 100 MG Oral Tablet [Seroquel]	SBD	3dc79540-2f24-4920-99cd-ef6482f68eb2	1
153640	quetiapine 200 MG Oral Tablet [Seroquel]	SBD	3dc79540-2f24-4920-99cd-ef6482f68eb2	1
153638	quetiapine 25 MG Oral Tablet [Seroquel]	SBD	3dc79540-2f24-4920-99cd-ef6482f68eb2	1
616489	quetiapine 50 MG Oral Tablet [Seroquel]	SBD	3dc79540-2f24-4920-99cd-ef6482f68eb2	1
312743	quetiapine 100 MG Oral Tablet	SCD	3dc79540-2f24-4920-99cd-ef6482f68eb2	1
317174	quetiapine 200 MG Oral Tablet	SCD	3dc79540-2f24-4920-99cd-ef6482f68eb2	1
312744	quetiapine 25 MG Oral Tablet	SCD	3dc79540-2f24-4920-99cd-ef6482f68eb2	1
616487	quetiapine 50 MG Oral Tablet	SCD	3dc79540-2f24-4920-99cd-ef6482f68eb2	1
312743	quetiapine (as quetiapine fumarate) 100 MG Oral Tablet	SY	3dc79540-2f24-4920-99cd-ef6482f68eb2	1
317174	quetiapine (as quetiapine fumarate) 200 MG Oral Tablet	SY	3dc79540-2f24-4920-99cd-ef6482f68eb2	1
312744	quetiapine (as quetiapine fumarate) 25 MG Oral Tablet	SY	3dc79540-2f24-4920-99cd-ef6482f68eb2	1
616487	quetiapine (as quetiapine fumarate) 50 MG Oral Tablet	SY	3dc79540-2f24-4920-99cd-ef6482f68eb2	1
153639	Seroquel 100 MG (as quetiapine fumarate) Oral Tablet	SY	3dc79540-2f24-4920-99cd-ef6482f68eb2	1
153639	Seroquel 100 MG Oral Tablet	SY	3dc79540-2f24-4920-99cd-ef6482f68eb2	1
153640	Seroquel 200 MG Oral Tablet	SY	3dc79540-2f24-4920-99cd-ef6482f68eb2	1
153638	Seroquel 25 MG (as quetiapine fumarate) Oral Tablet	SY	3dc79540-2f24-4920-99cd-ef6482f68eb2	1
153638	Seroquel 25 MG Oral Tablet	SY	3dc79540-2f24-4920-99cd-ef6482f68eb2	1
616489	Seroquel 50 MG (as quetiapine fumarate) Oral Tablet	SY	3dc79540-2f24-4920-99cd-ef6482f68eb2	1
616489	Seroquel 50 MG Oral Tablet	SY	3dc79540-2f24-4920-99cd-ef6482f68eb2	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-120-02	21695012002	15 in 1 BOTTLE	Historical