Quetiapine Fumarate

Product NDC: 50742-638
11-digit product format: 507420638
Labeler code: 50742
Product ID: 50742-638_57efb2c4-97c7-4f4b-8e1f-e73ec6d6c176
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: quetiapine fumarate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Ingenus Pharmaceuticals, LLC
Application: ANDA208947
Marketing category: ANDA
Marketing start: 2017-08-31
Substance: QUETIAPINE FUMARATE
Active strength: 300 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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A208947-001	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29
A208947-002	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29
A208947-003	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29
A208947-004	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29
A208947-005	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 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A208947-001	AB
A208947-002	AB
A208947-003	AB
A208947-004	AB
A208947-005	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 6 · 205 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	A208947-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208947-002	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208947-003	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208947-004	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208947-005	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	A208947-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208947-002	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	A208947-003	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	A208947-004	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	A208947-005	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208947-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208947-002	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208947-003	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208947-004	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208947-005	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	A208947-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208947-002	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	A208947-003	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	A208947-004	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	A208947-005	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	A208947-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208947-002	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	A208947-003	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	A208947-004	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	A208947-005	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	A208947-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208947-002	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	A208947-003	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	A208947-004	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	A208947-005	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	A208947-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208947-002	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	A208947-003	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	A208947-004	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	A208947-005	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	A208947-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208947-002	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	A208947-003	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	A208947-004	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	A208947-005	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-11-29	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 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	A208947-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208947-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208947-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208947-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208947-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208947-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208947-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208947-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208947-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208947-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208947-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208947-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208947-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208947-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208947-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208947-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208947-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208947-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208947-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208947-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208947-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208947-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208947-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208947-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208947-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208947-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208947-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208947-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208947-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208947-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208947-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208947-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208947-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208947-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208947-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208947-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208947-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208947-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208947-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208947-005	AB	1	`5bbf6a4d5a75…`

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	300 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 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
721791	Internal RxNorm lookup
721794	Internal RxNorm lookup
721796	Internal RxNorm lookup
853201	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
8923c441-c9aa-4b30-89d7-dbaaa7f66656	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
21205abd-8c89-4943-9f85-908f3d4fc3bb	Product name	5	20230501
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50742-638-10	Quetiapine Fumarate	1000 in 1 BOTTLE	TABLET, EXTENDED RELEASE	1000	13
50742-638-30	Quetiapine Fumarate	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30	13
50742-638-60	Quetiapine Fumarate	60 in 1 BOTTLE	TABLET, EXTENDED RELEASE	60	13
50742-638-90	Quetiapine Fumarate	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50742-638-60	EA - Each	50742-638	757195f2-eac2-4d56-889a-21bff543ee5b	1	2018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50742-638	QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE [INGENUS PHARMACEUTICALS, LLC]	12	Current NDC, Legacy NDC, 4 package rows	20230615_8923c441-c9aa-4b30-89d7-dbaaa7f66656.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Quetiapine Fumarate	QUETIAPINE FUMARATE	Ingenus Pharmaceuticals, LLC	8923c441-c9aa-4b30-89d7-dbaaa7f66656	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208947 application number: ANDA208947 ndc (product): 50742-638

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
895670	QUEtiapine fumarate 150 MG 24HR Extended Release Oral Tablet	PSN	8923c441-c9aa-4b30-89d7-dbaaa7f66656	13
721791	QUEtiapine fumarate 200 MG 24HR Extended Release Oral Tablet	PSN	8923c441-c9aa-4b30-89d7-dbaaa7f66656	13
721794	QUEtiapine fumarate 300 MG 24HR Extended Release Oral Tablet	PSN	8923c441-c9aa-4b30-89d7-dbaaa7f66656	13
721796	QUEtiapine fumarate 400 MG 24HR Extended Release Oral Tablet	PSN	8923c441-c9aa-4b30-89d7-dbaaa7f66656	13
853201	QUEtiapine fumarate 50 MG 24HR Extended Release Oral Tablet	PSN	8923c441-c9aa-4b30-89d7-dbaaa7f66656	13
895670	24 HR quetiapine 150 MG Extended Release Oral Tablet	SCD	8923c441-c9aa-4b30-89d7-dbaaa7f66656	13
721791	24 HR quetiapine 200 MG Extended Release Oral Tablet	SCD	8923c441-c9aa-4b30-89d7-dbaaa7f66656	13
721794	24 HR quetiapine 300 MG Extended Release Oral Tablet	SCD	8923c441-c9aa-4b30-89d7-dbaaa7f66656	13
721796	24 HR quetiapine 400 MG Extended Release Oral Tablet	SCD	8923c441-c9aa-4b30-89d7-dbaaa7f66656	13
853201	24 HR quetiapine 50 MG Extended Release Oral Tablet	SCD	8923c441-c9aa-4b30-89d7-dbaaa7f66656	13
895670	quetiapine 150 MG (as quetiapine fumarate 173 MG) 24 HR Extended Release Oral Tablet	SY	8923c441-c9aa-4b30-89d7-dbaaa7f66656	13
895670	quetiapine 150 MG 24 HR Extended Release Oral Tablet	SY	8923c441-c9aa-4b30-89d7-dbaaa7f66656	13
721791	quetiapine 200 MG (as quetiapine fumarate 230 MG) 24 HR Extended Release Oral Tablet	SY	8923c441-c9aa-4b30-89d7-dbaaa7f66656	13
721791	quetiapine 200 MG 24 HR Extended Release Oral Tablet	SY	8923c441-c9aa-4b30-89d7-dbaaa7f66656	13
721794	quetiapine 300 MG (as quetiapine fumarate 345 MG) 24 HR Extended Release Oral Tablet	SY	8923c441-c9aa-4b30-89d7-dbaaa7f66656	13
721794	quetiapine 300 MG 24 HR Extended Release Oral Tablet	SY	8923c441-c9aa-4b30-89d7-dbaaa7f66656	13
721796	quetiapine 400 MG (as quetiapine fumarate 461 MG) 24 HR Extended Release Oral Tablet	SY	8923c441-c9aa-4b30-89d7-dbaaa7f66656	13
853201	quetiapine 50 MG (as quetiapine fumarate 58 MG) 24 HR Extended Release Oral Tablet	SY	8923c441-c9aa-4b30-89d7-dbaaa7f66656	13
853201	quetiapine 50 MG 24 HR Extended Release Oral Tablet	SY	8923c441-c9aa-4b30-89d7-dbaaa7f66656	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50742-638-10	50742063810	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-638-10)	2017-08-31	0000-00-00	No	No	Current
50742-638-30	50742063830	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-638-30)	2017-08-31	0000-00-00	No	No	Current
50742-638-60	50742063860	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-638-60)	2017-08-31	0000-00-00	No	No	Current
50742-638-90	50742063890	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-638-90)	2017-08-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Quetiapine Fumarate	Ingenus Pharmaceuticals, LLC \| Novast Laboratories, Ltd.	2025-12-05	HUMAN PRESCRIPTION DRUG LABEL	13
Quetiapine Fumarate	Golden State Medical Supply, Inc.	2024-12-23	HUMAN PRESCRIPTION DRUG LABEL	8
Quetiapine Fumarate	REMEDYREPACK INC.	2019-08-26	HUMAN PRESCRIPTION DRUG LABEL	1