Quetiapine Fumarate

Product NDC: 0054-0220
11-digit product format: 000540220
Labeler code: 0054
Product ID: 0054-0220_73eed8f1-3912-40e6-8084-d8498616ee5d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Quetiapine Fumarate
Dosage form: TABLET
Route: ORAL
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA090120
Marketing category: ANDA
Marketing start: 2012-03-27
Substance: QUETIAPINE FUMARATE
Active strength: 25 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090120-001	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB		2012-03-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090120-001	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 2 · 41 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	A090120-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090120-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090120-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090120-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090120-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090120-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090120-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090120-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090120-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090120-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090120-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090120-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090120-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090120-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090120-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090120-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090120-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090120-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090120-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090120-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090120-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090120-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090120-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090120-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090120-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090120-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090120-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090120-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090120-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090120-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090120-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090120-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090120-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090120-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090120-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090120-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090120-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090120-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090120-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090120-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A090120-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090120-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090120-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090120-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090120-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090120-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090120-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090120-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090120-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090120-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090120-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090120-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090120-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090120-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090120-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090120-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090120-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090120-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090120-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090120-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090120-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090120-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090120-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090120-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090120-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090120-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090120-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090120-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090120-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090120-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090120-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090120-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090120-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090120-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090120-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090120-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090120-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090120-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090120-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090120-001	AB	1	`cb3db0bc1861…`

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	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 · 6 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
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
271e9fb7-3c70-43fc-8279-5adf189f3c22	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	SPL version
0054-0220-20	Quetiapine Fumarate	10 in 1 CARTON	TABLET	10	26
0054-0220-20	Quetiapine Fumarate	10 in 1 BLISTER PACK	TABLET	10	26
0054-0220-25	Quetiapine Fumarate	100 in 1 BOTTLE	TABLET	100	26
0054-0220-31	Quetiapine Fumarate	1000 in 1 BOTTLE	TABLET	1000	26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0054-0220-20	EA - Each	0054-0220	ce580ad1-f131-46a8-955a-8e2d454e5e73	1	2013-11-04
0054-0220-25	EA - Each	0054-0220	7095c665-2296-4f93-8c8f-5a151ca37721	1	2012-07-24
0054-0220-31	EA - Each	0054-0220	4fb73ddf-055c-4692-9947-c8140203211b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
QUETIAPINE FUMARATE	ACTIVE INGREDIENT	2S3PL1B6UJ	QUETIAPINE FUMARATE TABLET [ROXANE LABORATORIES, INC.]	6
QUETIAPINE	ACTIVE MOIETY	BGL0JSY5SI	QUETIAPINE FUMARATE TABLET [ROXANE LABORATORIES, INC.]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	QUETIAPINE FUMARATE TABLET [ROXANE LABORATORIES, INC.]	6
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	QUETIAPINE FUMARATE TABLET [ROXANE LABORATORIES, INC.]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	QUETIAPINE FUMARATE TABLET [ROXANE LABORATORIES, INC.]	6
POVIDONE K29/32	INACTIVE INGREDIENT	390RMW2PEQ	QUETIAPINE FUMARATE TABLET [ROXANE LABORATORIES, INC.]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	QUETIAPINE FUMARATE TABLET [ROXANE LABORATORIES, INC.]	6
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	QUETIAPINE FUMARATE TABLET [ROXANE LABORATORIES, INC.]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	QUETIAPINE FUMARATE TABLET [ROXANE LABORATORIES, INC.]	6
QUETIAPINE FUMARATE	ACTIVE INGREDIENT	2S3PL1B6UJ	QUETIAPINE FUMARATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
QUETIAPINE	ACTIVE MOIETY	BGL0JSY5SI	QUETIAPINE FUMARATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	QUETIAPINE FUMARATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	QUETIAPINE FUMARATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	QUETIAPINE FUMARATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
POVIDONE K29/32	INACTIVE INGREDIENT	390RMW2PEQ	QUETIAPINE FUMARATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	QUETIAPINE FUMARATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	QUETIAPINE FUMARATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	QUETIAPINE FUMARATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0054-0220	QUETIAPINE FUMARATE TABLET [HIKMA PHARMACEUTICALS USA INC.]	26	Current NDC, Legacy NDC, 4 package rows	20250328_271e9fb7-3c70-43fc-8279-5adf189f3c22.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Quetiapine Fumarate	QUETIAPINE FUMARATE	Golden State Medical Supply, Inc.	6fc9c8e2-6f34-aa43-e053-2a91aa0ac377	2025-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090120 application number: ANDA090120
Quetiapine Fumarate	QUETIAPINE FUMARATE	Hikma Pharmaceuticals USA Inc.	271e9fb7-3c70-43fc-8279-5adf189f3c22	2025-02-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090120 application number: ANDA090120 ndc (product): 0054-0220
Quetiapine Fumarate	QUETIAPINE FUMARATE	Aphena Pharma Solutions - Tennessee, LLC	60316ccd-c042-4ea0-9d05-3caf7cc2cab1	2021-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090120 application number: ANDA090120

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	271e9fb7-3c70-43fc-8279-5adf189f3c22	26
317174	QUEtiapine fumarate 200 MG Oral Tablet	PSN	271e9fb7-3c70-43fc-8279-5adf189f3c22	26
312744	QUEtiapine fumarate 25 MG Oral Tablet	PSN	271e9fb7-3c70-43fc-8279-5adf189f3c22	26
312745	QUEtiapine fumarate 300 MG Oral Tablet	PSN	271e9fb7-3c70-43fc-8279-5adf189f3c22	26
616483	QUEtiapine fumarate 400 MG Oral Tablet	PSN	271e9fb7-3c70-43fc-8279-5adf189f3c22	26
616487	QUEtiapine fumarate 50 MG Oral Tablet	PSN	271e9fb7-3c70-43fc-8279-5adf189f3c22	26
312743	quetiapine 100 MG Oral Tablet	SCD	271e9fb7-3c70-43fc-8279-5adf189f3c22	26
317174	quetiapine 200 MG Oral Tablet	SCD	271e9fb7-3c70-43fc-8279-5adf189f3c22	26
312744	quetiapine 25 MG Oral Tablet	SCD	271e9fb7-3c70-43fc-8279-5adf189f3c22	26
312745	quetiapine 300 MG Oral Tablet	SCD	271e9fb7-3c70-43fc-8279-5adf189f3c22	26
616483	quetiapine 400 MG Oral Tablet	SCD	271e9fb7-3c70-43fc-8279-5adf189f3c22	26
616487	quetiapine 50 MG Oral Tablet	SCD	271e9fb7-3c70-43fc-8279-5adf189f3c22	26
312743	quetiapine (as quetiapine fumarate) 100 MG Oral Tablet	SY	271e9fb7-3c70-43fc-8279-5adf189f3c22	26
317174	quetiapine (as quetiapine fumarate) 200 MG Oral Tablet	SY	271e9fb7-3c70-43fc-8279-5adf189f3c22	26
312744	quetiapine (as quetiapine fumarate) 25 MG Oral Tablet	SY	271e9fb7-3c70-43fc-8279-5adf189f3c22	26
312745	quetiapine (as quetiapine fumarate) 300 MG Oral Tablet	SY	271e9fb7-3c70-43fc-8279-5adf189f3c22	26
616483	quetiapine (as quetiapine fumarate) 400 MG Oral Tablet	SY	271e9fb7-3c70-43fc-8279-5adf189f3c22	26
616487	quetiapine (as quetiapine fumarate) 50 MG Oral Tablet	SY	271e9fb7-3c70-43fc-8279-5adf189f3c22	26
312743	QUEtiapine fumarate 100 MG Oral Tablet	PSN	6fc9c8e2-6f34-aa43-e053-2a91aa0ac377	11
317174	QUEtiapine fumarate 200 MG Oral Tablet	PSN	6fc9c8e2-6f34-aa43-e053-2a91aa0ac377	11
312744	QUEtiapine fumarate 25 MG Oral Tablet	PSN	6fc9c8e2-6f34-aa43-e053-2a91aa0ac377	11
312745	QUEtiapine fumarate 300 MG Oral Tablet	PSN	6fc9c8e2-6f34-aa43-e053-2a91aa0ac377	11
616483	QUEtiapine fumarate 400 MG Oral Tablet	PSN	6fc9c8e2-6f34-aa43-e053-2a91aa0ac377	11
616487	QUEtiapine fumarate 50 MG Oral Tablet	PSN	6fc9c8e2-6f34-aa43-e053-2a91aa0ac377	11
312743	quetiapine 100 MG Oral Tablet	SCD	6fc9c8e2-6f34-aa43-e053-2a91aa0ac377	11
317174	quetiapine 200 MG Oral Tablet	SCD	6fc9c8e2-6f34-aa43-e053-2a91aa0ac377	11
312744	quetiapine 25 MG Oral Tablet	SCD	6fc9c8e2-6f34-aa43-e053-2a91aa0ac377	11
312745	quetiapine 300 MG Oral Tablet	SCD	6fc9c8e2-6f34-aa43-e053-2a91aa0ac377	11
616483	quetiapine 400 MG Oral Tablet	SCD	6fc9c8e2-6f34-aa43-e053-2a91aa0ac377	11
616487	quetiapine 50 MG Oral Tablet	SCD	6fc9c8e2-6f34-aa43-e053-2a91aa0ac377	11
312743	quetiapine (as quetiapine fumarate) 100 MG Oral Tablet	SY	6fc9c8e2-6f34-aa43-e053-2a91aa0ac377	11
317174	quetiapine (as quetiapine fumarate) 200 MG Oral Tablet	SY	6fc9c8e2-6f34-aa43-e053-2a91aa0ac377	11
312744	quetiapine (as quetiapine fumarate) 25 MG Oral Tablet	SY	6fc9c8e2-6f34-aa43-e053-2a91aa0ac377	11
312745	quetiapine (as quetiapine fumarate) 300 MG Oral Tablet	SY	6fc9c8e2-6f34-aa43-e053-2a91aa0ac377	11
616483	quetiapine (as quetiapine fumarate) 400 MG Oral Tablet	SY	6fc9c8e2-6f34-aa43-e053-2a91aa0ac377	11
616487	quetiapine (as quetiapine fumarate) 50 MG Oral Tablet	SY	6fc9c8e2-6f34-aa43-e053-2a91aa0ac377	11
312744	QUEtiapine fumarate 25 MG Oral Tablet	PSN	520680bd-a1e4-16d7-e054-00144ff8d46c	3
312744	quetiapine 25 MG Oral Tablet	SCD	520680bd-a1e4-16d7-e054-00144ff8d46c	3
312744	quetiapine (as quetiapine fumarate) 25 MG Oral Tablet	SY	520680bd-a1e4-16d7-e054-00144ff8d46c	3
312743	QUEtiapine fumarate 100 MG Oral Tablet	PSN	3e482854-45ac-4de9-88a3-e5f70dbdc57b	1
317174	QUEtiapine fumarate 200 MG Oral Tablet	PSN	3e482854-45ac-4de9-88a3-e5f70dbdc57b	1
312744	QUEtiapine fumarate 25 MG Oral Tablet	PSN	3e482854-45ac-4de9-88a3-e5f70dbdc57b	1
312743	quetiapine 100 MG Oral Tablet	SCD	3e482854-45ac-4de9-88a3-e5f70dbdc57b	1
317174	quetiapine 200 MG Oral Tablet	SCD	3e482854-45ac-4de9-88a3-e5f70dbdc57b	1
312744	quetiapine 25 MG Oral Tablet	SCD	3e482854-45ac-4de9-88a3-e5f70dbdc57b	1
312743	quetiapine (as quetiapine fumarate) 100 MG Oral Tablet	SY	3e482854-45ac-4de9-88a3-e5f70dbdc57b	1
317174	quetiapine (as quetiapine fumarate) 200 MG Oral Tablet	SY	3e482854-45ac-4de9-88a3-e5f70dbdc57b	1
312744	quetiapine (as quetiapine fumarate) 25 MG Oral Tablet	SY	3e482854-45ac-4de9-88a3-e5f70dbdc57b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0054-0220-20	00054022020	10 BLISTER PACK in 1 CARTON (0054-0220-20) / 10 TABLET in 1 BLISTER PACK	10 blister pack	2012-03-27	0000-00-00	No	No	Current
0054-0220-25	00054022025	100 TABLET in 1 BOTTLE (0054-0220-25)	100 tablet	2012-03-27	0000-00-00	No	No	Current
0054-0220-31	00054022031	1000 TABLET in 1 BOTTLE (0054-0220-31)	1000 tablet	2012-03-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Quetiapine Fumarate	Golden State Medical Supply, Inc.	2025-04-03	HUMAN PRESCRIPTION DRUG LABEL	11
Quetiapine Fumarate	Hikma Pharmaceuticals USA Inc. \| West-Ward Columbus Inc.	2025-02-10	HUMAN PRESCRIPTION DRUG LABEL	26
Quetiapine Fumarate - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2022-01-20	HUMAN PRESCRIPTION DRUG LABEL	3
Quetiapine Fumarate	Aphena Pharma Solutions - Tennessee, LLC	2014-05-08	HUMAN PRESCRIPTION DRUG LABEL	1