Quetiapine Fumarate ER

Product NDC: 72189-586
Requested package NDC: 72189-586-30
11-digit product format: 721890586
Labeler code: 72189
Product ID: 72189-586_23820efc-4df8-9dc9-e063-6394a90a0bb4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Quetiapine Fumarate ER
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Direct_rx
Application: ANDA209635
Marketing category: ANDA
Marketing start: 2024-10-02
Substance: QUETIAPINE FUMARATE
Active strength: 150 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A209635-001	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29
A209635-002	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29
A209635-003	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29
A209635-004	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29
A209635-005	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A209635-001	AB
A209635-002	AB
A209635-003	AB
A209635-004	AB
A209635-005	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 6 · 215 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	A209635-001	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209635-002	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209635-003	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209635-004	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209635-005	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209635-001	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209635-002	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209635-003	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209635-004	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209635-005	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209635-001	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209635-002	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209635-003	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209635-004	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209635-005	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209635-001	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209635-002	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209635-003	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209635-004	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209635-005	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209635-001	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209635-002	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209635-003	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209635-004	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209635-005	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209635-001	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209635-002	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209635-003	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209635-004	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209635-005	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209635-001	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209635-002	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209635-003	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209635-004	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209635-005	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209635-001	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209635-002	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209635-003	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209635-004	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209635-005	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-16	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 215 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	A209635-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209635-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209635-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209635-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209635-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209635-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209635-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209635-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209635-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209635-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209635-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209635-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209635-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209635-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209635-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209635-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209635-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209635-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209635-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209635-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209635-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209635-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209635-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209635-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209635-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209635-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209635-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209635-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209635-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209635-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209635-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209635-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209635-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209635-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209635-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209635-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209635-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209635-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209635-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209635-005	AB	1	`03ed91905a0d…`

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: Quetiapine Fumarate ER
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
QUETIAPINE FUMARATE	150 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
895670	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
23820efc-4df7-9dc9-e063-6394a90a0bb4	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72189-586-30	Quetiapine Fumarate ER	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-586-30	EA - Each	72189-586	fd77b3c7-d87b-4d9f-9a09-2228db941a8e	1	2024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-586	QUETIAPINE FUMARATE ER TABLET, FILM COATED, EXTENDED RELEASE [DIRECT_RX]	1	Current NDC, 1 package rows	20241004_23820efc-4df7-9dc9-e063-6394a90a0bb4.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Quetiapine Extended Release	QUETIAPINE	REMEDYREPACK INC.	995731f7-aace-4140-b699-d6e8975c7c83	2026-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209635 application number: ANDA209635
Quetiapine Extended Release	QUETIAPINE	NuCare Pharmaceuticals, Inc.	44e9b338-b163-bee7-e063-6394a90a1338	2025-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209635 application number: ANDA209635
Quetiapine Extended Release	QUETIAPINE	Golden State Medical Supply, Inc.	04cd529c-198b-5b85-e063-6294a90a4684	2025-11-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209635 application number: ANDA209635
Quetiapine Extended Release	QUETIAPINE	ST. MARY'S MEDICAL PARK PHARMACY	3622cbd4-d7cb-57d4-e063-6294a90a5f24	2025-05-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209635 application number: ANDA209635
Quetiapine Extended Release	QUETIAPINE	ScieGen Pharmaceuticals, Inc	5e4a84b1-fb8c-44d0-8213-51e43d71db69	2025-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209635 application number: ANDA209635
Quetiapine Fumarate ER	QUETIAPINE FUMARATE ER	Direct_Rx	0917ef53-2647-b54b-e063-6294a90a4211	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209635 application number: ANDA209635
Quetiapine Fumarate ER	QUETIAPINE FUMARATE ER	Direct_rx	23820efc-4df7-9dc9-e063-6394a90a0bb4	2024-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209635 application number: ANDA209635 ndc (package): 72189-586-30 ndc (product): 72189-586 ndc11 (package): 72189058630
Quetiapine Extended Release	QUETIAPINE	ACI Healthcare USA, Inc.	07e4f3f4-42cb-4b22-bf8d-8c3279d26e97	2021-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209635 application number: ANDA209635

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
895670	QUEtiapine fumarate 150 MG 24HR Extended Release Oral Tablet	PSN	23820efc-4df7-9dc9-e063-6394a90a0bb4	1
895670	24 HR quetiapine 150 MG Extended Release Oral Tablet	SCD	23820efc-4df7-9dc9-e063-6394a90a0bb4	1
895670	quetiapine 150 MG (as quetiapine fumarate 173 MG) 24 HR Extended Release Oral Tablet	SY	23820efc-4df7-9dc9-e063-6394a90a0bb4	1
895670	quetiapine 150 MG 24 HR Extended Release Oral Tablet	SY	23820efc-4df7-9dc9-e063-6394a90a0bb4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72189-586-30	72189058630	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72189-586-30)	2024-10-02	No	No	Current