Quetiapine Fumarate

Product NDC: 71335-1562
Requested package NDC: 71335-1562-3
11-digit product format: 713351562
Labeler code: 71335
Product ID: 71335-1562_37b76bb8-f6d9-4a1c-9bea-e55e68ff7c0a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Quetiapine Fumarate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA201504
Marketing category: ANDA
Marketing start: 2013-03-01
Substance: QUETIAPINE FUMARATE
Active strength: 25 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71335-1562	71335-1562-3	D	Discontinued by firm		2026-08-03

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 287 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
2026-02-19 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…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201504-006	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2013-02-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201504-007	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2013-02-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201504-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2013-02-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201504-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2013-02-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201504-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2013-02-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201504-004	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2013-02-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201504-005	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2013-02-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201504-006	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2013-02-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201504-007	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2013-02-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201504-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2013-02-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201504-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2013-02-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201504-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2013-02-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201504-004	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2013-02-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201504-005	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2013-02-12	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 287 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201504-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201504-007	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201504-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201504-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201504-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201504-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201504-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201504-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201504-007	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201504-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201504-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201504-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201504-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201504-005	AB	1	`03ed91905a0d…`

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	25 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
312744	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
f75a4d38-ea0e-4780-abf2-67672894a11b	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
71335-1562-1	Quetiapine Fumarate	30 in 1 BOTTLE	TABLET, FILM COATED	30	107
71335-1562-2	Quetiapine Fumarate	60 in 1 BOTTLE	TABLET, FILM COATED	60	107
71335-1562-3	Quetiapine Fumarate	90 in 1 BOTTLE	TABLET, FILM COATED	90	107
71335-1562-4	Quetiapine Fumarate	120 in 1 BOTTLE	TABLET, FILM COATED	120	107
71335-1562-5	Quetiapine Fumarate	100 in 1 BOTTLE	TABLET, FILM COATED	100	107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-1562-1	EA - Each	71335-1562	095bf4d3-77be-4eef-94d5-150445297a86	1	2022-04-06
71335-1562-2	EA - Each	71335-1562	8ab7408f-d6be-4b2c-b1f9-e6c6a44db6b3	1	2025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-1562	QUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]	106	Current NDC, Legacy NDC, 5 package rows	20250502_f75a4d38-ea0e-4780-abf2-67672894a11b.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 2 · 29 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Quetiapine	QUETIAPINE	Coupler LLC	56052e5c-0b0b-c296-e063-6394a90a5ad6	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201504 application number: ANDA201504
Quetiapine Fumarate	QUETIAPINE FUMARATE	NuCare Pharmaceuticals,Inc.	16f48034-b8c9-ab2b-e063-6294a90adf65	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201504 application number: ANDA201504
Quetiapine Fumarate	QUETIAPINE FUMARATE	Direct_Rx	f6de1d2b-b10e-2e9a-e053-6394a90a735d	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201504 application number: ANDA201504
Quetiapine	QUETIAPINE	Cardinal Health 107, LLC	32bc1ecb-7285-4013-b266-ca783a62d617	2026-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201504 application number: ANDA201504
Quetiapine	QUETIAPINE	Major Pharmaceuticals	f9447739-9e21-4232-950f-174c0496ab66	2026-01-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201504 application number: ANDA201504
Quetiapine Fumarate	QUETIAPINE	A-S Medication Solutions	10288afa-c4dc-4897-9ec8-f4573d850779	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201504 application number: ANDA201504
Quetiapine Fumarate	QUETIAPINE FUMARATE	AvPAK	6b7d7d2f-a50b-8e21-2de4-ccc102016384	2025-12-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201504 application number: ANDA201504
Quetiapine	QUETIAPINE	ASCLEMED USA INC.	74e09734-26cb-42fe-b9a3-79cc10505e0b	2025-10-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201504 application number: ANDA201504
Quetiapine Fumarate	QUETIAPINE FUMARATE	Preferred Pharmaceuticals Inc.	717b55c4-a23f-4d74-8023-0f4e14d89ec8	2025-09-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201504 application number: ANDA201504
Quetiapine	QUETIAPINE	REMEDYREPACK INC.	b7aa0fce-1406-4665-a791-e30aed7b24ff	2025-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201504 application number: ANDA201504
Quetiapine	QUETIAPINE	Bryant Ranch Prepack	01261008-5f42-4844-8a65-d4545a67a309	2025-06-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201504 application number: ANDA201504
Quetiapine Fumarate	QUETIAPINE FUMARATE	Bryant Ranch Prepack	f75a4d38-ea0e-4780-abf2-67672894a11b	2025-06-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201504 application number: ANDA201504 ndc (package): 71335-1562-3 ndc (product): 71335-1562 ndc11 (package): 71335156203
Quetiapine Fumarate	QUETIAPINE FUMARATE	Direct_Rx	e4ce9d50-9786-2233-e053-2a95a90a276f	2025-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201504 application number: ANDA201504
Quetiapine	QUETIAPINE	Ascend Laboratories, LLC	3112a006-1c61-47f2-84f5-9a7670d09c9b	2025-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201504 application number: ANDA201504
Quetiapine Fumarate	QUETIAPINE FUMARATE	Bryant Ranch Prepack	6efc2886-7dcc-4dac-a212-76078a7efaa7	2025-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201504 application number: ANDA201504
Quetiapine Fumarate	QUETIAPINE FUMARATE	Bryant Ranch Prepack	45947f72-d870-4f6e-9e5f-38d6b324d5fe	2025-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201504 application number: ANDA201504
Quetiapine Fumarate	QUETIAPINE FUMARATE	Bryant Ranch Prepack	35b2069e-209a-41ac-84e6-377d4f19be87	2025-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201504 application number: ANDA201504
Quetiapine	QUETIAPINE	PD-Rx Pharmaceuticals, Inc.	da3c9642-9f8d-422b-8e12-2036d68f78ca	2025-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201504 application number: ANDA201504
Quetiapine Fumarate	QUETIAPINE FUMARATE	Preferred Pharmaceuticals Inc.	69275af7-1469-4405-a98e-e8b0f8d42dd9	2025-02-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201504 application number: ANDA201504
Quetiapine Fumarate	QUETIAPINE FUMARATE	Direct Rx	db48ec02-1119-f343-e053-2a95a90afb3b	2025-01-22	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
312744	QUEtiapine fumarate 25 MG Oral Tablet	PSN	f75a4d38-ea0e-4780-abf2-67672894a11b	107
312744	quetiapine 25 MG Oral Tablet	SCD	f75a4d38-ea0e-4780-abf2-67672894a11b	107
312744	quetiapine (as quetiapine fumarate) 25 MG Oral Tablet	SY	f75a4d38-ea0e-4780-abf2-67672894a11b	107

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-1562-3	71335156203	90 TABLET, FILM COATED in 1 BOTTLE (71335-1562-3)	2021-01-18	0000-00-00	No	No	Current