QUETIAPINE

Product NDC: 33342-137
11-digit product format: 333420137
Labeler code: 33342
Product ID: 33342-137_fb91b782-1195-4212-b130-9e078dc47dcd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: QUETIAPINE
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Macleods Pharmaceuticals Limited
Application: ANDA204253
Marketing category: ANDA
Marketing start: 2017-11-01
Substance: QUETIAPINE FUMARATE
Active strength: 400 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A204253-001	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29
A204253-002	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29
A204253-003	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29
A204253-004	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A204253-001	AB
A204253-002	AB
A204253-003	AB
A204253-004	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 5 · 164 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	A204253-001	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204253-002	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204253-003	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204253-004	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204253-001	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204253-002	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204253-003	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204253-004	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204253-001	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204253-002	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204253-003	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204253-004	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204253-001	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204253-002	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204253-003	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204253-004	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204253-001	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204253-002	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204253-003	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204253-004	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204253-001	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204253-002	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204253-003	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204253-004	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204253-001	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204253-002	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204253-003	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204253-004	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204253-001	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204253-002	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204253-003	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204253-004	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204253-001	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204253-002	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204253-003	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204253-004	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204253-001	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204253-002	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204253-003	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204253-004	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A204253-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204253-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204253-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204253-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204253-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204253-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204253-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204253-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204253-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204253-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204253-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204253-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204253-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204253-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204253-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204253-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204253-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204253-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204253-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204253-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204253-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204253-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204253-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204253-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204253-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204253-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204253-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204253-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204253-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204253-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204253-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204253-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204253-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204253-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204253-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204253-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204253-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204253-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204253-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204253-004	AB	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: QUETIAPINE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
QUETIAPINE FUMARATE	400 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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
721791	Internal RxNorm lookup
721794	Internal RxNorm lookup
721796	Internal RxNorm lookup
895670	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
d699b8c7-8a1c-44ed-85d8-c821a9c8c848	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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
21205abd-8c89-4943-9f85-908f3d4fc3bb	Product name	5	20230501
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
33342-137-09	QUETIAPINE	60 in 1 BOTTLE	TABLET, EXTENDED RELEASE	60		8
33342-137-15	QUETIAPINE	500 in 1 BOTTLE	TABLET, EXTENDED RELEASE	500		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
33342-137-09	EA - Each	33342-137	66fbb6c3-221f-419c-9e81-8bea8f84f8c2	1	2018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
33342-137	QUETIAPINE TABLET, EXTENDED RELEASE [MACLEODS PHARMACEUTICALS LIMITED]	8	Current NDC, Legacy NDC, 2 package rows	20230801_d699b8c7-8a1c-44ed-85d8-c821a9c8c848.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	QUETIAPINE	REMEDYREPACK INC.	90da6c48-3282-41dc-b4fa-75d33efa9fee	2026-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204253 application number: ANDA204253
QUETIAPINE	QUETIAPINE	REMEDYREPACK INC.	67872105-4ec6-4d46-b3b4-c672c93576d2	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204253 application number: ANDA204253
Quetiapine Fumarate ER	QUETIAPINE FUMARATE ER	Direct_Rx	3fb5c81f-ce5f-98bf-e063-6294a90a5711	2025-09-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204253 application number: ANDA204253
QUETIAPINE	QUETIAPINE	Bryant Ranch Prepack	b78b4e12-8ec4-470d-9bb5-665b5af328f5	2025-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204253 application number: ANDA204253
QUETIAPINE	QUETIAPINE	Macleods Pharmaceuticals Limited	d699b8c7-8a1c-44ed-85d8-c821a9c8c848	2023-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204253 application number: ANDA204253 ndc (product): 33342-137

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2S3PL1B6UJ	QUETIAPINE FUMARATE	111974-72-2	QUETIAPINE FUMARATE
BGL0JSY5SI	QUETIAPINE	111974-69-7	QUETIAPINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
895670	QUEtiapine fumarate 150 MG 24HR Extended Release Oral Tablet	PSN	d699b8c7-8a1c-44ed-85d8-c821a9c8c848	8
721791	QUEtiapine fumarate 200 MG 24HR Extended Release Oral Tablet	PSN	d699b8c7-8a1c-44ed-85d8-c821a9c8c848	8
721794	QUEtiapine fumarate 300 MG 24HR Extended Release Oral Tablet	PSN	d699b8c7-8a1c-44ed-85d8-c821a9c8c848	8
721796	QUEtiapine fumarate 400 MG 24HR Extended Release Oral Tablet	PSN	d699b8c7-8a1c-44ed-85d8-c821a9c8c848	8
895670	24 HR quetiapine 150 MG Extended Release Oral Tablet	SCD	d699b8c7-8a1c-44ed-85d8-c821a9c8c848	8
721791	24 HR quetiapine 200 MG Extended Release Oral Tablet	SCD	d699b8c7-8a1c-44ed-85d8-c821a9c8c848	8
721794	24 HR quetiapine 300 MG Extended Release Oral Tablet	SCD	d699b8c7-8a1c-44ed-85d8-c821a9c8c848	8
721796	24 HR quetiapine 400 MG Extended Release Oral Tablet	SCD	d699b8c7-8a1c-44ed-85d8-c821a9c8c848	8
895670	quetiapine 150 MG (as quetiapine fumarate 173 MG) 24 HR Extended Release Oral Tablet	SY	d699b8c7-8a1c-44ed-85d8-c821a9c8c848	8
895670	quetiapine 150 MG 24 HR Extended Release Oral Tablet	SY	d699b8c7-8a1c-44ed-85d8-c821a9c8c848	8
721791	quetiapine 200 MG (as quetiapine fumarate 230 MG) 24 HR Extended Release Oral Tablet	SY	d699b8c7-8a1c-44ed-85d8-c821a9c8c848	8
721791	quetiapine 200 MG 24 HR Extended Release Oral Tablet	SY	d699b8c7-8a1c-44ed-85d8-c821a9c8c848	8
721794	quetiapine 300 MG (as quetiapine fumarate 345 MG) 24 HR Extended Release Oral Tablet	SY	d699b8c7-8a1c-44ed-85d8-c821a9c8c848	8
721794	quetiapine 300 MG 24 HR Extended Release Oral Tablet	SY	d699b8c7-8a1c-44ed-85d8-c821a9c8c848	8
721796	quetiapine 400 MG (as quetiapine fumarate 461 MG) 24 HR Extended Release Oral Tablet	SY	d699b8c7-8a1c-44ed-85d8-c821a9c8c848	8
721796	QUEtiapine fumarate 400 MG 24HR Extended Release Oral Tablet	PSN	b78b4e12-8ec4-470d-9bb5-665b5af328f5	1
721796	QUEtiapine fumarate 400 MG 24HR Extended Release Oral Tablet	PSN	3fb5c81f-ce5f-98bf-e063-6294a90a5711	1
721796	24 HR quetiapine 400 MG Extended Release Oral Tablet	SCD	b78b4e12-8ec4-470d-9bb5-665b5af328f5	1
721796	24 HR quetiapine 400 MG Extended Release Oral Tablet	SCD	3fb5c81f-ce5f-98bf-e063-6294a90a5711	1
721796	quetiapine 400 MG (as quetiapine fumarate 461 MG) 24 HR Extended Release Oral Tablet	SY	3fb5c81f-ce5f-98bf-e063-6294a90a5711	1
721796	quetiapine 400 MG (as quetiapine fumarate 461 MG) 24 HR Extended Release Oral Tablet	SY	b78b4e12-8ec4-470d-9bb5-665b5af328f5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
33342-137-09	33342013709	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-137-09)	2017-11-01	0000-00-00	No	No	Current
33342-137-15	33342013715	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-137-15)	2017-11-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
QUETIAPINE	REMEDYREPACK INC.	2026-07-17	HUMAN PRESCRIPTION DRUG LABEL	1
Quetiapine Fumarate ER	Direct_Rx	2025-09-26	HUMAN PRESCRIPTION DRUG LABEL	1
QUETIAPINE	Bryant Ranch Prepack	2025-06-02	HUMAN PRESCRIPTION DRUG LABEL	1
QUETIAPINE	Macleods Pharmaceuticals Limited	2023-03-30	Human Prescription Drug Label	8