Quetiapine fumarate

Product NDC: 71335-0772
Requested package NDC: 71335-0772-2
11-digit product format: 713350772
Labeler code: 71335
Product ID: 71335-0772_338f745e-ca35-7caa-e063-6394a90a0e46
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Quetiapine fumarate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA201190
Marketing category: ANDA
Marketing start: 2012-03-28
Substance: QUETIAPINE FUMARATE
Active strength: 300 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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A201190-001	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL		2012-03-27
A201190-002	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27
A201190-003	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27
A201190-004	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL		2012-03-27
A201190-005	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27
A201190-006	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL		2012-03-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A201190-002	AB
A201190-003	AB
A201190-005	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 7 · 258 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	A201190-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL		2012-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201190-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201190-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201190-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL		2012-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201190-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201190-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL		2012-03-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201190-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL		2012-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201190-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201190-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201190-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL		2012-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201190-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201190-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL		2012-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201190-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201190-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201190-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201190-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL		2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201190-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201190-006	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	A201190-001	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	A201190-002	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	A201190-003	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	A201190-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL		2012-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201190-005	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	A201190-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201190-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201190-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201190-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201190-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201190-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201190-006	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	A201190-001	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	A201190-002	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	A201190-003	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	A201190-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201190-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201190-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201190-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201190-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201190-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201190-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 247 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	A201190-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201190-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201190-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201190-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201190-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201190-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201190-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201190-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201190-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201190-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201190-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201190-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201190-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201190-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201190-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201190-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201190-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201190-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201190-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201190-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201190-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201190-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201190-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201190-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201190-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201190-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201190-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201190-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201190-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201190-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201190-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201190-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201190-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201190-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201190-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201190-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201190-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201190-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201190-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201190-006	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
Listing expiration: 2026-12-31

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
9a024071-e620-48e8-9f22-d4cda5dc5ab1	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
71335-0772-1	Quetiapine fumarate	30 in 1 BOTTLE	TABLET, FILM COATED	30	7
71335-0772-2	Quetiapine fumarate	60 in 1 BOTTLE	TABLET, FILM COATED	60	7
71335-0772-3	Quetiapine fumarate	28 in 1 BOTTLE	TABLET, FILM COATED	28	7
71335-0772-4	Quetiapine fumarate	90 in 1 BOTTLE	TABLET, FILM COATED	90	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-0772-1	EA - Each	71335-0772	a2e8b643-a4da-4cfc-b616-778a97cfce67	1	2022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-0772	QUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]	7	Current NDC, Legacy NDC, 4 package rows	20250426_9a024071-e620-48e8-9f22-d4cda5dc5ab1.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Quetiapine fumarate	QUETIAPINE FUMARATE	Bryant Ranch Prepack	c52a9bff-8a03-44f5-9128-799c7dca0467	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201190 application number: ANDA201190
Quetiapine fumarate	QUETIAPINE FUMARATE	Bryant Ranch Prepack	3eb39b4e-4c79-43b9-a30e-b4221c0e2bd2	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201190 application number: ANDA201190
Quetiapine fumarate	QUETIAPINE FUMARATE	Sun Pharmaceutical Industries, Inc.	ffe52b98-9872-48c1-90fd-8fcd37c3432f	2026-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201190 application number: ANDA201190
Quetiapine fumarate	QUETIAPINE FUMARATE	Coupler LLC	258eac65-69ed-404f-e063-6394a90a19ef	2025-05-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201190 application number: ANDA201190
Quetiapine fumarate	QUETIAPINE FUMARATE	Bryant Ranch Prepack	9a024071-e620-48e8-9f22-d4cda5dc5ab1	2025-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201190 application number: ANDA201190 ndc (package): 71335-0772-2 ndc (product): 71335-0772 ndc11 (package): 71335077202

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
312745	QUEtiapine fumarate 300 MG Oral Tablet	PSN	9a024071-e620-48e8-9f22-d4cda5dc5ab1	7
312745	quetiapine 300 MG Oral Tablet	SCD	9a024071-e620-48e8-9f22-d4cda5dc5ab1	7
312745	quetiapine (as quetiapine fumarate) 300 MG Oral Tablet	SY	9a024071-e620-48e8-9f22-d4cda5dc5ab1	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-0772-2	71335077202	60 TABLET, FILM COATED in 1 BOTTLE (71335-0772-2)	2022-05-02	0000-00-00	No	No	Current