Quetiapine

Product NDC: 71205-402
Requested package NDC: 71205-402-60
11-digit product format: 712050402
Labeler code: 71205
Product ID: 71205-402_6258bbaf-4ac0-4621-b95e-e6b032aa0518
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Quetiapine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA077745
Marketing category: ANDA
Marketing start: 2012-03-27
Substance: QUETIAPINE FUMARATE
Active strength: 400 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 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
A077745-001	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27
A077745-002	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27
A077745-003	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27
A077745-004	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-27
A077745-005	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27
A077745-006	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27
A077745-007	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077745-001	AB
A077745-002	AB
A077745-003	AB
A077745-004	AB
A077745-005	AB
A077745-006	AB
A077745-007	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	A077745-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077745-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077745-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077745-004	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077745-005	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077745-006	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077745-007	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077745-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077745-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077745-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077745-004	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077745-005	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077745-006	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077745-007	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077745-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077745-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077745-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077745-004	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077745-005	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077745-006	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077745-007	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077745-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077745-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077745-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077745-004	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077745-005	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077745-006	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077745-007	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077745-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077745-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077745-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077745-004	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077745-005	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077745-006	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077745-007	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077745-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077745-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077745-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077745-004	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077745-005	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`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	A077745-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077745-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077745-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077745-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077745-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077745-006	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077745-007	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077745-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077745-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077745-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077745-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077745-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077745-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077745-007	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077745-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077745-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077745-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077745-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077745-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077745-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077745-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077745-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077745-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077745-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077745-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077745-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077745-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077745-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077745-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077745-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077745-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077745-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077745-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077745-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077745-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077745-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077745-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077745-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077745-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077745-005	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
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
QUETIAPINE FUMARATE	400 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
616483	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
6258bbaf-4ac0-4621-b95e-e6b032aa0518	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	SPL version
71205-402-30	Quetiapine	30 in 1 BOTTLE	TABLET, FILM COATED	30	1
71205-402-60	Quetiapine	60 in 1 BOTTLE	TABLET, FILM COATED	60	1
71205-402-90	Quetiapine	90 in 1 BOTTLE	TABLET, FILM COATED	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71205-402-30	EA - Each	71205-402	5cbc8b19-14e7-4b10-bf84-dbd49160da3d	1	2020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-402	QUETIAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1	Current NDC, Legacy NDC, 3 package rows	20200222_6258bbaf-4ac0-4621-b95e-e6b032aa0518.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Quetiapine	QUETIAPINE	Teva Pharmaceuticals USA, Inc.	c1d4ef59-bf58-44fe-9b46-1af42e2f7f8b	2025-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077745 application number: ANDA077745
Quetiapine	QUETIAPINE	Aphena Pharma Solutions - Tennessee, LLC	fdece055-aeb5-43d6-b730-54dd74bde304	2023-04-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077745 application number: ANDA077745
Quetiapine	QUETIAPINE	Proficient Rx LP	dd6b6088-943e-413b-9886-88dd9c622be4	2022-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077745 application number: ANDA077745
Quetiapine	QUETIAPINE	Proficient Rx LP	6258bbaf-4ac0-4621-b95e-e6b032aa0518	2020-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077745 application number: ANDA077745 ndc (package): 71205-402-60 ndc (product): 71205-402 ndc11 (package): 71205040260

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
616483	QUEtiapine fumarate 400 MG Oral Tablet	PSN	6258bbaf-4ac0-4621-b95e-e6b032aa0518	1
616483	quetiapine 400 MG Oral Tablet	SCD	6258bbaf-4ac0-4621-b95e-e6b032aa0518	1
616483	quetiapine (as quetiapine fumarate) 400 MG Oral Tablet	SY	6258bbaf-4ac0-4621-b95e-e6b032aa0518	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71205-402-60	71205040260	60 TABLET, FILM COATED in 1 BOTTLE (71205-402-60)	2020-02-13	0000-00-00	No	No	Current