Quetiapine Fumarate

Product NDC: 72189-446
Requested package NDC: 72189-446-60
11-digit product format: 721890446
Labeler code: 72189
Product ID: 72189-446_4c4b8f97-e2a3-7bdf-e063-6294a90af5cf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Quetiapine Fumarate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Direct_Rx
Application: ANDA201504
Marketing category: ANDA
Marketing start: 2023-03-14
Substance: QUETIAPINE FUMARATE
Active strength: 25 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 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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A201504-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2013-02-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A201504-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2013-02-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A201504-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2013-02-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A201504-004	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2013-02-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A201504-005	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2013-02-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A201504-006	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2013-02-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A201504-007	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2013-02-12	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A201504-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A201504-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A201504-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A201504-004	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A201504-005	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A201504-006	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A201504-007	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 ndc (package): 72189-446-60 ndc (product): 72189-446 ndc11 (package): 72189044660
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
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

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	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
f6de1d2b-b10e-2e9a-e053-6394a90a735d	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
72189-446-30	Quetiapine Fumarate	30 in 1 BOTTLE	TABLET, FILM COATED	30		3
72189-446-60	Quetiapine Fumarate	60 in 1 BOTTLE	TABLET, FILM COATED	60		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-446-30	EA - Each	72189-446	a8fd7980-aff0-4a8d-8b0e-40cf8052a196	1	2023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-446	QUETIAPINE FUMARATE TABLET [DIRECT_RX]	2	Current NDC, 2 package rows	20250123_f6de1d2b-b10e-2e9a-e053-6394a90a735d.zip

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	f6de1d2b-b10e-2e9a-e053-6394a90a735d	3
312744	quetiapine 25 MG Oral Tablet	SCD	f6de1d2b-b10e-2e9a-e053-6394a90a735d	3
312744	quetiapine (as quetiapine fumarate) 25 MG Oral Tablet	SY	f6de1d2b-b10e-2e9a-e053-6394a90a735d	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72189-446-60	72189044660	60 TABLET, FILM COATED in 1 BOTTLE (72189-446-60)	2023-03-14	No	No	Current