SEROQUEL

Product NDC: 0310-0272
Requested package NDC: 0310-0272-10
11-digit product format: 003100272
Labeler code: 0310
Product ID: 0310-0272_aef69992-4a20-4d55-b85c-7c0799619ce6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: quetiapine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: AstraZeneca Pharmaceuticals LP
Application: NDA020639
Marketing category: NDA
Marketing start: 1997-10-01
Marketing end: 2027-06-30
Substance: QUETIAPINE FUMARATE
Active strength: 200 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Current FDA listing: Yes

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

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SEROQUEL	QUETIAPINE FUMARATE	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-12-20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 · 301 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
2026-09-14 22:38:34	2026-08	N020639-001	SEROQUEL	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	1997-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020639-002	SEROQUEL	EQ 100MG BASE	TABLET / ORAL	AB	RLD	1997-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020639-003	SEROQUEL	EQ 200MG BASE	TABLET / ORAL	AB	RLD	1997-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020639-005	SEROQUEL	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2000-07-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020639-006	SEROQUEL	EQ 400MG BASE	TABLET / ORAL	AB	RLD	2005-10-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020639-007	SEROQUEL	EQ 50MG BASE	TABLET / ORAL	AB	RLD	2005-10-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020639-001	SEROQUEL	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	1997-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020639-002	SEROQUEL	EQ 100MG BASE	TABLET / ORAL	AB	RLD	1997-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020639-003	SEROQUEL	EQ 200MG BASE	TABLET / ORAL	AB	RLD	1997-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020639-005	SEROQUEL	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2000-07-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020639-006	SEROQUEL	EQ 400MG BASE	TABLET / ORAL	AB	RLD	2005-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020639-007	SEROQUEL	EQ 50MG BASE	TABLET / ORAL	AB	RLD	2005-10-04	`caaa826d4ba7…`
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…`

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	N020639-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020639-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020639-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020639-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020639-006	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020639-007	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020639-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020639-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020639-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020639-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020639-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020639-007	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: SEROQUEL

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
QUETIAPINE FUMARATE	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2S3PL1B6UJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
153638	Internal RxNorm lookup
153639	Internal RxNorm lookup
153640	Internal RxNorm lookup
284509	Internal RxNorm lookup
312743	Internal RxNorm lookup
312744	Internal RxNorm lookup
312745	Internal RxNorm lookup
317174	Internal RxNorm lookup
616483	Internal RxNorm lookup
616485	Internal RxNorm lookup
616487	Internal RxNorm lookup
616489	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0584dda8-bc3c-48fe-1a90-79608f78e8a0	Available on FDA.report

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
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0310-0272-10	SEROQUEL	100 in 1 BOTTLE	TABLET, FILM COATED	100	50
0310-0272-39	SEROQUEL	1 in 1 BLISTER PACK	TABLET, FILM COATED	1	50
0310-0272-39	SEROQUEL	100 in 1 CARTON	TABLET, FILM COATED	100	50

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0310-0272-10	EA - Each	0310-0272	e997e48b-3c75-4cfb-abe2-24d69bc63940	1	2012-07-24
0310-0272-39	EA - Each	0310-0272	cb73287d-bd4a-44a9-8e52-868c97afd135	1	2012-07-24

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 [BRYANT RANCH PREPACK]	1000
QUETIAPINE	ACTIVE MOIETY	BGL0JSY5SI	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
WATER	INACTIVE INGREDIENT	059QF0KO0R	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
QUETIAPINE FUMARATE	ACTIVE INGREDIENT	2S3PL1B6UJ	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]	34
QUETIAPINE	ACTIVE MOIETY	BGL0JSY5SI	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]	34
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]	34
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]	34
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]	34
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]	34
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]	34
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]	34
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]	34
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]	34
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]	34
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]	34
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]	34
WATER	INACTIVE INGREDIENT	059QF0KO0R	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]	34
QUETIAPINE FUMARATE	ACTIVE INGREDIENT	2S3PL1B6UJ	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	20
QUETIAPINE	ACTIVE MOIETY	BGL0JSY5SI	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	20
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	20
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	20
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	20
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	20
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	20
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	20
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	20
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	20
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	20
WATER	INACTIVE INGREDIENT	059QF0KO0R	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	20
QUETIAPINE FUMARATE	ACTIVE INGREDIENT	2S3PL1B6UJ	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
QUETIAPINE	ACTIVE MOIETY	BGL0JSY5SI	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0310-0272	SEROQUEL (QUETIAPINE) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]	50	Current NDC, Legacy NDC, 3 package rows	20250312_0584dda8-bc3c-48fe-1a90-79608f78e8a0.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 ndc (package): 0310-0272-10 ndc (product): 0310-0272 ndc11 (package): 00310027210

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2S3PL1B6UJ	QUETIAPINE FUMARATE	111974-72-2	QUETIAPINE FUMARATE
BGL0JSY5SI	QUETIAPINE	111974-69-7	quetiapine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312743	QUEtiapine fumarate 100 MG Oral Tablet	PSN	0584dda8-bc3c-48fe-1a90-79608f78e8a0	50
317174	QUEtiapine fumarate 200 MG Oral Tablet	PSN	0584dda8-bc3c-48fe-1a90-79608f78e8a0	50
312744	QUEtiapine fumarate 25 MG Oral Tablet	PSN	0584dda8-bc3c-48fe-1a90-79608f78e8a0	50
312745	QUEtiapine fumarate 300 MG Oral Tablet	PSN	0584dda8-bc3c-48fe-1a90-79608f78e8a0	50
616483	QUEtiapine fumarate 400 MG Oral Tablet	PSN	0584dda8-bc3c-48fe-1a90-79608f78e8a0	50
616487	QUEtiapine fumarate 50 MG Oral Tablet	PSN	0584dda8-bc3c-48fe-1a90-79608f78e8a0	50
153639	SEROquel 100 MG Oral Tablet	PSN	0584dda8-bc3c-48fe-1a90-79608f78e8a0	50
153640	SeroQUEL 200 MG Oral Tablet	PSN	0584dda8-bc3c-48fe-1a90-79608f78e8a0	50
153638	SeroQUEL 25 MG Oral Tablet	PSN	0584dda8-bc3c-48fe-1a90-79608f78e8a0	50
284509	SeroQUEL 300 MG Oral Tablet	PSN	0584dda8-bc3c-48fe-1a90-79608f78e8a0	50
616485	SeroQUEL 400 MG Oral Tablet	PSN	0584dda8-bc3c-48fe-1a90-79608f78e8a0	50
616489	SeroQUEL 50 MG Oral Tablet	PSN	0584dda8-bc3c-48fe-1a90-79608f78e8a0	50
153639	quetiapine 100 MG Oral Tablet [Seroquel]	SBD	0584dda8-bc3c-48fe-1a90-79608f78e8a0	50
153640	quetiapine 200 MG Oral Tablet [Seroquel]	SBD	0584dda8-bc3c-48fe-1a90-79608f78e8a0	50
153638	quetiapine 25 MG Oral Tablet [Seroquel]	SBD	0584dda8-bc3c-48fe-1a90-79608f78e8a0	50
284509	quetiapine 300 MG Oral Tablet [Seroquel]	SBD	0584dda8-bc3c-48fe-1a90-79608f78e8a0	50
616485	quetiapine 400 MG Oral Tablet [Seroquel]	SBD	0584dda8-bc3c-48fe-1a90-79608f78e8a0	50
616489	quetiapine 50 MG Oral Tablet [Seroquel]	SBD	0584dda8-bc3c-48fe-1a90-79608f78e8a0	50
312743	quetiapine 100 MG Oral Tablet	SCD	0584dda8-bc3c-48fe-1a90-79608f78e8a0	50
317174	quetiapine 200 MG Oral Tablet	SCD	0584dda8-bc3c-48fe-1a90-79608f78e8a0	50
312744	quetiapine 25 MG Oral Tablet	SCD	0584dda8-bc3c-48fe-1a90-79608f78e8a0	50
312745	quetiapine 300 MG Oral Tablet	SCD	0584dda8-bc3c-48fe-1a90-79608f78e8a0	50
616483	quetiapine 400 MG Oral Tablet	SCD	0584dda8-bc3c-48fe-1a90-79608f78e8a0	50
616487	quetiapine 50 MG Oral Tablet	SCD	0584dda8-bc3c-48fe-1a90-79608f78e8a0	50
312743	quetiapine (as quetiapine fumarate) 100 MG Oral Tablet	SY	0584dda8-bc3c-48fe-1a90-79608f78e8a0	50
317174	quetiapine (as quetiapine fumarate) 200 MG Oral Tablet	SY	0584dda8-bc3c-48fe-1a90-79608f78e8a0	50
312744	quetiapine (as quetiapine fumarate) 25 MG Oral Tablet	SY	0584dda8-bc3c-48fe-1a90-79608f78e8a0	50
312745	quetiapine (as quetiapine fumarate) 300 MG Oral Tablet	SY	0584dda8-bc3c-48fe-1a90-79608f78e8a0	50
616483	quetiapine (as quetiapine fumarate) 400 MG Oral Tablet	SY	0584dda8-bc3c-48fe-1a90-79608f78e8a0	50
616487	quetiapine (as quetiapine fumarate) 50 MG Oral Tablet	SY	0584dda8-bc3c-48fe-1a90-79608f78e8a0	50
153639	Seroquel 100 MG (as quetiapine fumarate) Oral Tablet	SY	0584dda8-bc3c-48fe-1a90-79608f78e8a0	50
153639	Seroquel 100 MG Oral Tablet	SY	0584dda8-bc3c-48fe-1a90-79608f78e8a0	50
153640	Seroquel 200 MG Oral Tablet	SY	0584dda8-bc3c-48fe-1a90-79608f78e8a0	50
153638	Seroquel 25 MG (as quetiapine fumarate) Oral Tablet	SY	0584dda8-bc3c-48fe-1a90-79608f78e8a0	50
153638	Seroquel 25 MG Oral Tablet	SY	0584dda8-bc3c-48fe-1a90-79608f78e8a0	50
284509	Seroquel 300 MG (as quetiapine fumarate) Oral Tablet	SY	0584dda8-bc3c-48fe-1a90-79608f78e8a0	50
284509	Seroquel 300 MG Oral Tablet	SY	0584dda8-bc3c-48fe-1a90-79608f78e8a0	50
616485	Seroquel 400 MG (as quetiapine fumarate) Oral Tablet	SY	0584dda8-bc3c-48fe-1a90-79608f78e8a0	50
616485	Seroquel 400 MG Oral Tablet	SY	0584dda8-bc3c-48fe-1a90-79608f78e8a0	50
616489	Seroquel 50 MG (as quetiapine fumarate) Oral Tablet	SY	0584dda8-bc3c-48fe-1a90-79608f78e8a0	50
616489	Seroquel 50 MG Oral Tablet	SY	0584dda8-bc3c-48fe-1a90-79608f78e8a0	50
312743	QUEtiapine fumarate 100 MG Oral Tablet	PSN	276e53bf-d3c0-4457-a76e-ee39c1cd2a3d	1
317174	QUEtiapine fumarate 200 MG Oral Tablet	PSN	276e53bf-d3c0-4457-a76e-ee39c1cd2a3d	1
312744	QUEtiapine fumarate 25 MG Oral Tablet	PSN	276e53bf-d3c0-4457-a76e-ee39c1cd2a3d	1
312745	QUEtiapine fumarate 300 MG Oral Tablet	PSN	276e53bf-d3c0-4457-a76e-ee39c1cd2a3d	1
616483	QUEtiapine fumarate 400 MG Oral Tablet	PSN	276e53bf-d3c0-4457-a76e-ee39c1cd2a3d	1
616487	QUEtiapine fumarate 50 MG Oral Tablet	PSN	276e53bf-d3c0-4457-a76e-ee39c1cd2a3d	1
153639	SEROquel 100 MG Oral Tablet	PSN	276e53bf-d3c0-4457-a76e-ee39c1cd2a3d	1
153640	SeroQUEL 200 MG Oral Tablet	PSN	276e53bf-d3c0-4457-a76e-ee39c1cd2a3d	1
153638	SeroQUEL 25 MG Oral Tablet	PSN	276e53bf-d3c0-4457-a76e-ee39c1cd2a3d	1
284509	SeroQUEL 300 MG Oral Tablet	PSN	276e53bf-d3c0-4457-a76e-ee39c1cd2a3d	1
616485	SeroQUEL 400 MG Oral Tablet	PSN	276e53bf-d3c0-4457-a76e-ee39c1cd2a3d	1
616489	SeroQUEL 50 MG Oral Tablet	PSN	276e53bf-d3c0-4457-a76e-ee39c1cd2a3d	1
153639	quetiapine 100 MG Oral Tablet [Seroquel]	SBD	276e53bf-d3c0-4457-a76e-ee39c1cd2a3d	1
153640	quetiapine 200 MG Oral Tablet [Seroquel]	SBD	276e53bf-d3c0-4457-a76e-ee39c1cd2a3d	1
153638	quetiapine 25 MG Oral Tablet [Seroquel]	SBD	276e53bf-d3c0-4457-a76e-ee39c1cd2a3d	1
284509	quetiapine 300 MG Oral Tablet [Seroquel]	SBD	276e53bf-d3c0-4457-a76e-ee39c1cd2a3d	1
616485	quetiapine 400 MG Oral Tablet [Seroquel]	SBD	276e53bf-d3c0-4457-a76e-ee39c1cd2a3d	1
616489	quetiapine 50 MG Oral Tablet [Seroquel]	SBD	276e53bf-d3c0-4457-a76e-ee39c1cd2a3d	1
312743	quetiapine 100 MG Oral Tablet	SCD	276e53bf-d3c0-4457-a76e-ee39c1cd2a3d	1
317174	quetiapine 200 MG Oral Tablet	SCD	276e53bf-d3c0-4457-a76e-ee39c1cd2a3d	1
312744	quetiapine 25 MG Oral Tablet	SCD	276e53bf-d3c0-4457-a76e-ee39c1cd2a3d	1
312745	quetiapine 300 MG Oral Tablet	SCD	276e53bf-d3c0-4457-a76e-ee39c1cd2a3d	1
616483	quetiapine 400 MG Oral Tablet	SCD	276e53bf-d3c0-4457-a76e-ee39c1cd2a3d	1
616487	quetiapine 50 MG Oral Tablet	SCD	276e53bf-d3c0-4457-a76e-ee39c1cd2a3d	1
312743	quetiapine (as quetiapine fumarate) 100 MG Oral Tablet	SY	276e53bf-d3c0-4457-a76e-ee39c1cd2a3d	1
317174	quetiapine (as quetiapine fumarate) 200 MG Oral Tablet	SY	276e53bf-d3c0-4457-a76e-ee39c1cd2a3d	1
312744	quetiapine (as quetiapine fumarate) 25 MG Oral Tablet	SY	276e53bf-d3c0-4457-a76e-ee39c1cd2a3d	1
312745	quetiapine (as quetiapine fumarate) 300 MG Oral Tablet	SY	276e53bf-d3c0-4457-a76e-ee39c1cd2a3d	1
616483	quetiapine (as quetiapine fumarate) 400 MG Oral Tablet	SY	276e53bf-d3c0-4457-a76e-ee39c1cd2a3d	1
616487	quetiapine (as quetiapine fumarate) 50 MG Oral Tablet	SY	276e53bf-d3c0-4457-a76e-ee39c1cd2a3d	1
153639	Seroquel 100 MG (as quetiapine fumarate) Oral Tablet	SY	276e53bf-d3c0-4457-a76e-ee39c1cd2a3d	1
153639	Seroquel 100 MG Oral Tablet	SY	276e53bf-d3c0-4457-a76e-ee39c1cd2a3d	1
153640	Seroquel 200 MG Oral Tablet	SY	276e53bf-d3c0-4457-a76e-ee39c1cd2a3d	1
153638	Seroquel 25 MG (as quetiapine fumarate) Oral Tablet	SY	276e53bf-d3c0-4457-a76e-ee39c1cd2a3d	1
153638	Seroquel 25 MG Oral Tablet	SY	276e53bf-d3c0-4457-a76e-ee39c1cd2a3d	1
284509	Seroquel 300 MG (as quetiapine fumarate) Oral Tablet	SY	276e53bf-d3c0-4457-a76e-ee39c1cd2a3d	1
284509	Seroquel 300 MG Oral Tablet	SY	276e53bf-d3c0-4457-a76e-ee39c1cd2a3d	1
616485	Seroquel 400 MG (as quetiapine fumarate) Oral Tablet	SY	276e53bf-d3c0-4457-a76e-ee39c1cd2a3d	1
616485	Seroquel 400 MG Oral Tablet	SY	276e53bf-d3c0-4457-a76e-ee39c1cd2a3d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0310-0272-10	00310027210	100 TABLET, FILM COATED in 1 BOTTLE (0310-0272-10)	1997-10-01	2027-06-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SEROQUEL	AstraZeneca Pharmaceuticals LP \| AstraZeneca PLC	2025-01-22	HUMAN PRESCRIPTION DRUG LABEL	50
SEROQUEL	PD-Rx Pharmaceuticals, Inc.	2022-03-11	HUMAN PRESCRIPTION DRUG LABEL	45
SEROQUEL	Bryant Ranch Prepack	2012-10-24	HUMAN PRESCRIPTION DRUG LABEL	1000
SEROQUEL	Contract Pharmacy Services-PA	2010-06-01	HUMAN PRESCRIPTION DRUG LABEL	1