Quetiapine fumarate

Product NDC: 70518-2901
Requested package NDC: 70518-2901-0
11-digit product format: 705182901
Labeler code: 70518
Product ID: 70518-2901_4d66c2b1-56c9-286a-e063-6394a90a6fcd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: quetiapine fumarate
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA201109
Marketing category: ANDA
Marketing start: 2020-10-07
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A201109-001	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27
A201109-002	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27
A201109-003	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27
A201109-004	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27
A201109-005	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27
A201109-006	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201109-001	AB
A201109-002	AB
A201109-003	AB
A201109-004	AB
A201109-005	AB
A201109-006	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 · 246 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	A201109-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201109-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201109-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201109-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201109-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201109-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201109-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201109-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201109-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201109-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201109-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201109-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201109-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201109-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201109-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201109-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201109-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201109-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201109-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201109-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201109-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201109-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201109-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201109-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201109-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201109-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201109-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201109-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201109-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201109-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201109-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201109-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201109-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201109-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201109-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201109-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201109-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201109-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201109-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201109-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 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	A201109-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201109-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201109-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201109-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201109-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201109-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201109-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201109-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201109-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201109-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201109-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201109-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201109-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201109-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201109-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201109-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201109-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201109-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201109-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201109-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201109-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201109-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201109-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201109-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201109-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201109-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201109-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201109-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201109-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201109-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201109-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201109-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201109-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201109-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201109-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201109-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201109-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201109-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201109-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201109-004	AB	1	`2680178bc6a6…`

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
c6c454c4-3eae-48ae-bf17-5dccdb659141	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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2022-02-09	These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS.QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997
2022-02-09	These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS.QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997
2022-01-28	These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS.QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997
2022-01-28	These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS.QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70518-2901-0	Quetiapine fumarate	30 in 1 BLISTER PACK	TABLET	30		5

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 2 · 31 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Quetiapine fumarate	QUETIAPINE FUMARATE	REMEDYREPACK INC.	c6c454c4-3eae-48ae-bf17-5dccdb659141	2026-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201109 application number: ANDA201109 ndc (package): 70518-2901-0 ndc (product): 70518-2901 ndc11 (package): 70518290100
Quetiapine fumarate	QUETIAPINE FUMARATE	REMEDYREPACK INC.	d38f0f4e-dc0f-4c92-a212-c4da3db74801	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201109 application number: ANDA201109
Quetiapine fumarate	QUETIAPINE FUMARATE	REMEDYREPACK INC.	ea9b9ed1-4be0-4dc0-b1dd-239caff5253e	2026-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201109 application number: ANDA201109
Quetiapine fumarate	QUETIAPINE FUMARATE	REMEDYREPACK INC.	02b19885-2987-4c46-8d2a-5e59656f72e8	2026-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201109 application number: ANDA201109
Quetiapine fumarate	QUETIAPINE FUMARATE	REMEDYREPACK INC.	695415b1-083d-4540-9f41-bde4b201f834	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201109 application number: ANDA201109
Quetiapine fumarate	QUETIAPINE FUMARATE	Bryant Ranch Prepack	94a81681-381e-4b3b-89ac-e86dcbe7f890	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201109 application number: ANDA201109
Quetiapine fumarate	QUETIAPINE FUMARATE	Bryant Ranch Prepack	fd9cce28-0052-4b0b-8a66-a1615e082d95	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201109 application number: ANDA201109
Quetiapine fumarate	QUETIAPINE	Coupler LLC	5643d339-50ea-405d-e063-6394a90a3b70	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201109 application number: ANDA201109
Quetiapine fumarate	QUETIAPINE	Unit Dose Solutions, Inc.	55f358e1-9458-b197-e063-6394a90a3f0e	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201109 application number: ANDA201109
Quetiapine fumarate	QUETIAPINE FUMARATE	Unit Dose Solutions, Inc.	55f574bc-ec55-93e2-e063-6394a90a1d47	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201109 application number: ANDA201109
Quetiapine fumarate	QUETIAPINE	Unit Dose Solutions, Inc.	559fdce5-ab3e-0d02-e063-6394a90a7fbd	2026-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201109 application number: ANDA201109
Quetiapine fumarate	QUETIAPINE	Unit Dose Solutions, Inc.	55a5671b-7771-0adf-e063-6294a90acfa6	2026-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201109 application number: ANDA201109
Quetiapine fumarate	QUETIAPINE FUMARATE	St. Mary's Medical Park Pharmacy	36248b77-277c-7d66-e063-6394a90ae1e8	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201109 application number: ANDA201109
Quetiapine fumarate	QUETIAPINE	Coupler LLC	544f6e91-e61f-c57a-e063-6294a90af9d1	2026-06-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201109 application number: ANDA201109
Quetiapine fumarate	QUETIAPINE FUMARATE	St. Mary's Medical Park Pharmacy	3624100f-6e3f-a2ad-e063-6294a90a0fc0	2026-06-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201109 application number: ANDA201109
Quetiapine fumarate	QUETIAPINE FUMARATE	Lupin Pharmaceuticals, Inc.	a951cd63-d329-47c9-965a-582fa73a07c6	2026-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201109 application number: ANDA201109
Quetiapine fumarate	QUETIAPINE	Coupler LLC	533154bb-a596-c88b-e063-6294a90a8956	2026-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201109 application number: ANDA201109
Quetiapine fumarate	QUETIAPINE	Coupler LLC	52ba669d-c846-03c2-e063-6394a90ac0f0	2026-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201109 application number: ANDA201109
Quetiapine fumarate	QUETIAPINE	American Health Packaging	9f927ae2-a0ae-4953-99ba-8de59ee5bfca	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201109 application number: ANDA201109
Quetiapine fumarate	QUETIAPINE FUMARATE	Quallent Pharmaceuticals Health LLC	d51c5bf6-950d-493b-be55-de575c5ef2e7	2026-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201109 application number: ANDA201109

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	c6c454c4-3eae-48ae-bf17-5dccdb659141	5
616487	quetiapine 50 MG Oral Tablet	SCD	c6c454c4-3eae-48ae-bf17-5dccdb659141	5
616487	quetiapine (as quetiapine fumarate) 50 MG Oral Tablet	SY	c6c454c4-3eae-48ae-bf17-5dccdb659141	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-2901-0	70518290100	30 TABLET in 1 BLISTER PACK (70518-2901-0)	30 tablet	2020-10-07	0000-00-00	No	No	Current