Quetiapine Fumarate

Product NDC: 72189-366
11-digit product format: 721890366
Labeler code: 72189
Product ID: 72189-366_37b38291-50c8-00c9-e063-6394a90a83ef
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Quetiapine Fumarate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Direct_Rx
Application: ANDA201504
Marketing category: ANDA
Marketing start: 2022-07-27
Substance: QUETIAPINE FUMARATE
Active strength: 50 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 4 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
2025-01-20 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	72189-366-60	`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	72189-366-60	`0efc9e666f02…`	`f202fb6c5f17…`

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	Approval date
A201504-001	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2013-02-12
A201504-002	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2013-02-12
A201504-003	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2013-02-12
A201504-004	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2013-02-12
A201504-005	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2013-02-12
A201504-006	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2013-02-12
A201504-007	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2013-02-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 7 matching rows.

Application-product, TE code table
Application-product	TE code
A201504-001	AB
A201504-002	AB
A201504-003	AB
A201504-004	AB
A201504-005	AB
A201504-006	AB
A201504-007	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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A201504-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2013-02-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201504-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2013-02-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201504-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2013-02-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201504-004	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2013-02-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201504-005	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2013-02-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201504-006	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2013-02-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201504-007	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2013-02-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201504-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2013-02-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201504-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2013-02-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201504-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2013-02-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201504-004	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2013-02-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201504-005	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2013-02-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201504-006	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2013-02-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201504-007	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2013-02-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201504-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2013-02-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201504-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2013-02-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201504-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2013-02-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201504-004	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2013-02-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201504-005	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2013-02-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201504-006	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2013-02-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201504-007	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2013-02-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201504-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2013-02-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201504-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2013-02-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201504-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2013-02-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201504-004	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2013-02-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201504-005	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2013-02-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201504-006	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2013-02-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201504-007	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2013-02-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201504-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2013-02-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201504-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2013-02-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201504-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2013-02-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201504-004	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2013-02-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201504-005	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2013-02-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201504-006	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2013-02-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201504-007	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2013-02-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201504-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2013-02-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201504-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2013-02-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201504-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2013-02-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201504-004	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2013-02-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201504-005	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2013-02-12	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 301 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	A201504-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201504-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201504-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201504-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201504-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201504-006	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201504-007	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201504-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201504-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201504-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201504-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201504-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201504-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201504-007	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201504-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201504-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201504-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201504-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201504-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201504-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201504-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201504-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201504-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201504-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201504-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201504-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201504-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201504-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201504-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201504-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201504-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201504-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201504-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201504-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201504-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201504-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201504-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201504-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201504-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201504-005	AB	1	`fd3edfee7708…`

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
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
QUETIAPINE FUMARATE	50 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
616487	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
e4ce9d50-9786-2233-e053-2a95a90a276f	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
72189-366-30	Quetiapine Fumarate	30 in 1 BOTTLE	TABLET, FILM COATED	30		3
72189-366-60	Quetiapine Fumarate	60 in 1 BOTTLE	TABLET, FILM COATED	60		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-366-30	EA - Each	72189-366	a0f56404-e194-49e6-9ea4-47c2bc1caba7	1	2025-07-08
72189-366-60	EA - Each	72189-366	1f57d9f6-5eab-4b89-a68f-bfcf2f043a69	1	2022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-366	QUETIAPINE FUMARATE TABLET [DIRECT_RX]	2	Current NDC, Legacy NDC, 2 package rows	20250123_e4ce9d50-9786-2233-e053-2a95a90a276f.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 2 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Quetiapine Fumarate	QUETIAPINE FUMARATE	Proficient Rx LP	392dd5cf-4777-4985-b62b-7370134dee26	2024-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201504 application number: ANDA201504
Quetiapine Fumarate	QUETIAPINE FUMARATE	A-S Medication Solutions	ccacb909-8ee5-4223-bfee-9cfeae470ecf	2023-11-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201504 application number: ANDA201504
Quetiapine Fumarate	QUETIAPINE FUMARATE	Proficient Rx LP	85f973e0-93e6-4856-9266-62136acb2532	2023-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201504 application number: ANDA201504
Quetiapine Fumarate	QUETIAPINE FUMARATE	A-S Medication Solutions	95156201-ed16-4806-98a7-d42acc902126	2023-06-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201504 application number: ANDA201504
Quetiapine Fumarate	QUETIAPINE FUMARATE	Proficient Rx LP	c1f2ccba-62f3-44e7-b06f-dea61eac9e93	2023-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201504 application number: ANDA201504
Quetiapine Fumarate	QUETIAPINE FUMARATE	Proficient Rx LP	03517f29-f270-4350-a57a-fbe1967b0096	2019-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201504 application number: ANDA201504

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
616487	QUEtiapine fumarate 50 MG Oral Tablet	PSN	e4ce9d50-9786-2233-e053-2a95a90a276f	3
616487	quetiapine 50 MG Oral Tablet	SCD	e4ce9d50-9786-2233-e053-2a95a90a276f	3
616487	quetiapine (as quetiapine fumarate) 50 MG Oral Tablet	SY	e4ce9d50-9786-2233-e053-2a95a90a276f	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72189-366-30	72189036630	30 TABLET, FILM COATED in 1 BOTTLE (72189-366-30)	2022-07-27		No	No	Current
72189-366-60	72189036660	60 TABLET, FILM COATED in 1 BOTTLE (72189-366-60)	2022-07-27	0000-00-00	No	No	Current