Quetiapine Fumarate

Product NDC: 67046-1649
Requested package NDC: 67046-1649-3
11-digit product format: 670461649
Labeler code: 67046
Product ID: 67046-1649_48727af1-1bd2-125a-e063-6394a90a7150
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Quetiapine Fumarate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Coupler LLC
Application: ANDA202674
Marketing category: ANDA
Marketing start: 2026-01-15
Substance: QUETIAPINE FUMARATE
Active strength: 50 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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202674-001	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-08
A202674-002	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-08
A202674-003	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-08
A202674-004	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2016-03-08
A202674-005	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2016-03-08
A202674-006	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-03-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A202674-001	AB
A202674-002	AB
A202674-003	AB
A202674-004	AB
A202674-005	AB
A202674-006	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	A202674-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202674-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202674-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202674-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2016-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202674-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2016-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202674-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-03-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202674-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202674-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202674-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202674-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2016-03-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202674-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2016-03-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202674-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-03-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202674-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202674-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202674-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202674-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2016-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202674-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2016-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202674-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-03-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202674-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202674-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202674-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202674-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2016-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202674-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2016-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202674-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-03-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202674-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202674-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202674-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202674-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2016-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202674-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2016-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202674-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-03-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202674-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202674-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202674-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202674-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2016-03-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202674-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2016-03-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202674-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-03-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202674-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202674-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202674-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202674-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2016-03-08	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 258 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	A202674-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202674-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202674-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202674-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202674-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202674-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202674-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202674-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202674-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202674-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202674-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202674-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202674-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202674-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202674-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202674-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202674-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202674-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202674-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202674-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202674-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202674-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202674-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202674-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202674-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202674-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202674-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202674-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202674-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202674-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202674-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202674-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202674-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202674-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202674-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202674-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202674-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202674-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202674-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202674-004	AB	1	`b8a1b40f171c…`

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: 2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
4872793c-a7be-1b65-e063-6394a90a8b3a	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
67046-1649-3	Quetiapine Fumarate	30 in 1 BLISTER PACK	TABLET, FILM COATED	30		1

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Quetiapine Fumarate	QUETIAPINE FUMARATE	REMEDYREPACK INC.	b84e1614-b077-4ea5-8d11-df68f2b926de	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202674 application number: ANDA202674
Quetiapine Fumarate	QUETIAPINE FUMARATE	A-S Medication Solutions	42bd7dd3-9f81-4d8b-bce9-302e5559da2f	2026-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202674 application number: ANDA202674
Quetiapine Fumarate	QUETIAPINE FUMARATE	REMEDYREPACK INC.	479c9555-5d1e-4e5c-bfde-f3812829edd8	2026-02-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202674 application number: ANDA202674
Quetiapine Fumarate	QUETIAPINE FUMARATE	Coupler LLC	4872793c-a7be-1b65-e063-6394a90a8b3a	2026-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202674 application number: ANDA202674 ndc (package): 67046-1649-3 ndc (product): 67046-1649 ndc11 (package): 67046164903
Quetiapine Fumarate	QUETIAPINE FUMARATE	NuCare Pharmaceuticals, Inc.	458cae68-c11d-e760-e063-6394a90ac04e	2025-12-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202674 application number: ANDA202674
Quetiapine Fumarate	QUETIAPINE FUMARATE	Bryant Ranch Prepack	1618989e-2e6b-49ff-81b5-cf80d1dcfab4	2025-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202674 application number: ANDA202674
Quetiapine Fumarate	QUETIAPINE FUMARATE	NCS HealthCare of KY, LLC dba Vangard Labs	d73655d3-4b3f-40b4-92cb-053ad4f21a92	2025-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202674 application number: ANDA202674
Quetiapine Fumarate	QUETIAPINE FUMARATE	Unichem Pharmaceuticals (USA), Inc.	bdc9354b-172e-4bb3-895a-6c7cfef0ef14	2025-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202674 application number: ANDA202674
Quetiapine Fumarate	QUETIAPINE FUMARATE	Advanced Rx Pharmacy of Tennessee, LLC	d323b6c0-55fa-6caa-e053-2a95a90a3cff	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202674 application number: ANDA202674
Quetiapine Fumarate	QUETIAPINE FUMARATE	A-S Medication Solutions	845159aa-1ac2-41b7-ac21-d4b03e43203b	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202674 application number: ANDA202674

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
616487	QUEtiapine fumarate 50 MG Oral Tablet	PSN	4872793c-a7be-1b65-e063-6394a90a8b3a	1
616487	quetiapine 50 MG Oral Tablet	SCD	4872793c-a7be-1b65-e063-6394a90a8b3a	1
616487	quetiapine (as quetiapine fumarate) 50 MG Oral Tablet	SY	4872793c-a7be-1b65-e063-6394a90a8b3a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
67046-1649-3	67046164903	30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1649-3)	2026-01-15	No	No	Current