Quetiapine Fumarate

Product NDC: 16571-718
11-digit product format: 165710718
Labeler code: 16571
Product ID: 16571-718_b7aef4ea-0c7d-496f-b567-613189147c7e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Quetiapine Fumarate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA091388
Marketing category: ANDA
Marketing start: 2012-03-27
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

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
A091388-001	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27
A091388-002	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27
A091388-003	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27
A091388-004	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-27
A091388-005	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27
A091388-006	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27
A091388-007	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
A091388-001	AB
A091388-002	AB
A091388-003	AB
A091388-004	AB
A091388-005	AB
A091388-006	AB
A091388-007	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	A091388-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091388-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091388-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091388-004	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091388-005	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091388-006	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091388-007	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	A091388-001	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	A091388-002	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	A091388-003	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	A091388-004	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	A091388-005	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	A091388-006	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	A091388-007	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091388-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091388-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091388-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091388-004	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091388-005	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091388-006	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091388-007	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	A091388-001	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	A091388-002	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	A091388-003	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	A091388-004	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	A091388-005	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	A091388-006	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	A091388-007	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	A091388-001	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	A091388-002	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	A091388-003	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	A091388-004	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091388-005	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091388-006	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091388-007	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091388-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091388-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091388-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091388-004	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091388-005	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`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	A091388-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091388-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091388-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091388-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091388-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091388-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091388-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091388-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091388-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091388-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091388-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091388-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091388-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091388-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091388-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091388-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091388-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091388-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091388-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091388-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091388-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091388-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091388-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091388-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091388-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091388-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091388-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091388-007	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091388-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091388-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091388-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091388-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091388-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091388-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091388-007	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091388-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091388-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091388-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091388-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091388-005	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	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 · 7 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312743	Internal RxNorm lookup
312744	Internal RxNorm lookup
312745	Internal RxNorm lookup
317174	Internal RxNorm lookup
389201	Internal RxNorm lookup
616483	Internal RxNorm lookup
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
532c8ace-4cf5-4a08-bae7-2af8c41ffa3d	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
16571-718-01	Quetiapine Fumarate	100 in 1 BOTTLE	TABLET, FILM COATED	100		7
16571-718-10	Quetiapine Fumarate	1000 in 1 BOTTLE	TABLET, FILM COATED	1000		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16571-718-01	EA - Each	16571-718	48f1cc3b-2aa9-4ff9-a3f7-a60a2077979a	1	2022-02-07
16571-718-10	EA - Each	16571-718	b64a17de-b9cd-467c-b86c-2cd9922a506d	1	2022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16571-718	QUETIAPINE FUMARATE TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.]	6	Current NDC, Legacy NDC, 2 package rows	20250427_532c8ace-4cf5-4a08-bae7-2af8c41ffa3d.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 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Quetiapine Fumarate	QUETIAPINE FUMARATE	NorthStar Rx LLC	e6e25ef9-2671-489e-8eca-58bedb4f59ab	2026-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091388 application number: ANDA091388
Quetiapine Fumarate	QUETIAPINE FUMARATE	REMEDYREPACK INC.	b90390d8-6ebc-48b3-8b4d-6a3ff7d19ef6	2026-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091388 application number: ANDA091388
Quetiapine Fumarate	QUETIAPINE FUMARATE	Bryant Ranch Prepack	58541ffd-58c3-49aa-ad90-7e91a3c0b7d6	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091388 application number: ANDA091388
Quetiapine Fumarate	QUETIAPINE FUMARATE	Bryant Ranch Prepack	d3dcfb51-e67d-44dc-9186-4729f6414bf1	2026-05-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091388 application number: ANDA091388
Quetiapine Fumarate	QUETIAPINE FUMARATE	Bryant Ranch Prepack	aa0d27fd-569a-4573-b45d-2de5f5a30294	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091388 application number: ANDA091388
Quetiapine Fumarate	QUETIAPINE FUMARATE	Bryant Ranch Prepack	897184b1-de3c-4d59-91be-3069325fd5b2	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091388 application number: ANDA091388
Quetiapine Fumarate	QUETIAPINE FUMARATE	REMEDYREPACK INC.	da5c118f-404c-4453-aa10-a8656b1d7501	2026-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091388 application number: ANDA091388
Quetiapine Fumarate	QUETIAPINE FUMARATE	REMEDYREPACK INC.	911bf26c-a89a-4ce1-8ff5-cfda03d0a482	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091388 application number: ANDA091388
Quetiapine Fumarate	QUETIAPINE FUMARATE	Bryant Ranch Prepack	f0ad842c-a0c2-4855-a55b-353b5338980f	2026-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091388 application number: ANDA091388
Quetiapine Fumarate	QUETIAPINE FUMARATE	REMEDYREPACK INC.	41dbd5a5-4ae2-4ac1-8135-0fdac5c170b5	2026-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091388 application number: ANDA091388
Quetiapine Fumarate	QUETIAPINE FUMARATE	A-S Medication Solutions	55018271-1f8f-4683-afee-8203c3bd9acc	2026-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091388 application number: ANDA091388
Quetiapine Fumarate	QUETIAPINE FUMARATE	Rising Pharma Holdings, Inc.	532c8ace-4cf5-4a08-bae7-2af8c41ffa3d	2025-10-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091388 application number: ANDA091388 ndc (product): 16571-718
Quetiapine Fumarate	QUETIAPINE FUMARATE	Coupler LLC	3eed13b8-7464-3720-e063-6294a90a1245	2025-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091388 application number: ANDA091388
Quetiapine Fumarate	QUETIAPINE FUMARATE	Bryant Ranch Prepack	49ebd00b-e0a2-45c3-9cff-4b94d1a6b5ad	2025-09-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091388 application number: ANDA091388
Quetiapine Fumarate	QUETIAPINE FUMARATE	Aurobindo Pharma Limited	8df82f5a-aa0e-4f8c-bae1-2f32ede3d7b6	2025-09-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091388 application number: ANDA091388
Quetiapine Fumarate	QUETIAPINE FUMARATE	Preferred Pharmaceuticals Inc.	951a098a-d905-4723-89e1-71bf1551dcb6	2025-04-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091388 application number: ANDA091388
Quetiapine Fumarate	QUETIAPINE FUMARATE	Direct_Rx	face6c19-3dd9-b188-e053-6294a90a62d0	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091388 application number: ANDA091388
Quetiapine Fumarate	QUETIAPINE FUMARATE	Direct_Rx	fceb9f47-8da7-7138-e053-6294a90a5558	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091388 application number: ANDA091388
Quetiapine Fumarate	QUETIAPINE FUMARATE	Preferred Pharmaceuticals Inc.	8acc0ed3-6e4f-4799-8252-5a163938fddc	2025-01-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091388 application number: ANDA091388
Quetiapine Fumarate	QUETIAPINE FUMARATE	NuCare Pharmaceuticals,Inc.	0fdbe32f-d04a-5666-e063-6294a90a8e36	2024-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091388 application number: ANDA091388

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
312743	QUEtiapine fumarate 100 MG Oral Tablet	PSN	532c8ace-4cf5-4a08-bae7-2af8c41ffa3d	7
389201	QUEtiapine fumarate 150 MG Oral Tablet	PSN	532c8ace-4cf5-4a08-bae7-2af8c41ffa3d	7
317174	QUEtiapine fumarate 200 MG Oral Tablet	PSN	532c8ace-4cf5-4a08-bae7-2af8c41ffa3d	7
312744	QUEtiapine fumarate 25 MG Oral Tablet	PSN	532c8ace-4cf5-4a08-bae7-2af8c41ffa3d	7
312745	QUEtiapine fumarate 300 MG Oral Tablet	PSN	532c8ace-4cf5-4a08-bae7-2af8c41ffa3d	7
616483	QUEtiapine fumarate 400 MG Oral Tablet	PSN	532c8ace-4cf5-4a08-bae7-2af8c41ffa3d	7
616487	QUEtiapine fumarate 50 MG Oral Tablet	PSN	532c8ace-4cf5-4a08-bae7-2af8c41ffa3d	7
312743	quetiapine 100 MG Oral Tablet	SCD	532c8ace-4cf5-4a08-bae7-2af8c41ffa3d	7
389201	quetiapine 150 MG Oral Tablet	SCD	532c8ace-4cf5-4a08-bae7-2af8c41ffa3d	7
317174	quetiapine 200 MG Oral Tablet	SCD	532c8ace-4cf5-4a08-bae7-2af8c41ffa3d	7
312744	quetiapine 25 MG Oral Tablet	SCD	532c8ace-4cf5-4a08-bae7-2af8c41ffa3d	7
312745	quetiapine 300 MG Oral Tablet	SCD	532c8ace-4cf5-4a08-bae7-2af8c41ffa3d	7
616483	quetiapine 400 MG Oral Tablet	SCD	532c8ace-4cf5-4a08-bae7-2af8c41ffa3d	7
616487	quetiapine 50 MG Oral Tablet	SCD	532c8ace-4cf5-4a08-bae7-2af8c41ffa3d	7
312743	quetiapine (as quetiapine fumarate) 100 MG Oral Tablet	SY	532c8ace-4cf5-4a08-bae7-2af8c41ffa3d	7
389201	quetiapine (as quetiapine fumarate) 150 MG Oral Tablet	SY	532c8ace-4cf5-4a08-bae7-2af8c41ffa3d	7
317174	quetiapine (as quetiapine fumarate) 200 MG Oral Tablet	SY	532c8ace-4cf5-4a08-bae7-2af8c41ffa3d	7
312744	quetiapine (as quetiapine fumarate) 25 MG Oral Tablet	SY	532c8ace-4cf5-4a08-bae7-2af8c41ffa3d	7
312745	quetiapine (as quetiapine fumarate) 300 MG Oral Tablet	SY	532c8ace-4cf5-4a08-bae7-2af8c41ffa3d	7
616483	quetiapine (as quetiapine fumarate) 400 MG Oral Tablet	SY	532c8ace-4cf5-4a08-bae7-2af8c41ffa3d	7
616487	quetiapine (as quetiapine fumarate) 50 MG Oral Tablet	SY	532c8ace-4cf5-4a08-bae7-2af8c41ffa3d	7
616487	QUEtiapine fumarate 50 MG Oral Tablet	PSN	d3dcfb51-e67d-44dc-9186-4729f6414bf1	2
616487	quetiapine 50 MG Oral Tablet	SCD	d3dcfb51-e67d-44dc-9186-4729f6414bf1	2
616487	quetiapine (as quetiapine fumarate) 50 MG Oral Tablet	SY	d3dcfb51-e67d-44dc-9186-4729f6414bf1	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16571-718-01	16571071801	100 TABLET, FILM COATED in 1 BOTTLE (16571-718-01)	2012-03-27	0000-00-00	No	No	Current
16571-718-10	16571071810	1000 TABLET, FILM COATED in 1 BOTTLE (16571-718-10)	2012-03-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Quetiapine Fumarate	Bryant Ranch Prepack	2026-05-06	HUMAN PRESCRIPTION DRUG LABEL	2
Quetiapine Fumarate	Rising Pharma Holdings, Inc. \| Aurobindo Pharma Limited	2025-10-28	Human Prescription Drug Label	7
Quetiapine Fumarate	Coupler LLC \| Aurobindo Pharma Limited	2025-09-16	HUMAN PRESCRIPTION DRUG LABEL	1