Quetiapine Fumarate

Product NDC: 68071-3599
11-digit product format: 680713599
Labeler code: 68071
Product ID: 68071-3599_4ee28b5b-3e74-37c3-e063-6294a90a2070
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Quetiapine Fumarate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA201504
Marketing category: ANDA
Marketing start: 2013-03-01
Substance: QUETIAPINE FUMARATE
Active strength: 300 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 308 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
2026-10-15 13:18:30	2026-09	A201504-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2013-02-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201504-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2013-02-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201504-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2013-02-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201504-004	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2013-02-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201504-005	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2013-02-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201504-006	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2013-02-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201504-007	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2013-02-12	`c2088c7a36db…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 308 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A201504-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201504-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201504-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201504-004	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201504-005	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201504-006	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201504-007	AB	1	`c2088c7a36db…`
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…`

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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
QUETIAPINE FUMARATE	300 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
312745	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
16f48034-b8c9-ab2b-e063-6294a90adf65	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
68071-3599-6	Quetiapine Fumarate	60 in 1 BOTTLE	TABLET	60		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-3599	QUETIAPINE FUMARATE TABLET [NUCARE PHARMACEUTICALS,INC.]	1	Current NDC, 1 package rows	20240427_16f48034-b8c9-ab2b-e063-6294a90adf65.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68071-3599-6	68071359906	60 TABLET, FILM COATED in 1 BOTTLE (68071-3599-6)	2026-04-07	No	No	Current