Quetiapine fumarate

Product NDC: 68001-183
Requested package NDC: 68001-183-00
11-digit product format: 680010183
Labeler code: 68001
Product ID: 68001-183_4e775bd2-4ec9-32b4-e063-6294a90acf3d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: quetiapine
Dosage form: TABLET
Route: ORAL
Labeler: BluePoint Laboratories
Application: ANDA201109
Marketing category: ANDA
Marketing start: 2013-02-28
Substance: QUETIAPINE FUMARATE
Active strength: 300 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 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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A201109-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A201109-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A201109-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A201109-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A201109-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A201109-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A201109-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A201109-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A201109-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A201109-004	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A201109-005	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A201109-006	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
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

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	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 · 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
874e50ad-5da0-4ac3-9290-79442c91399e	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
68001-183-00	Quetiapine fumarate	100 in 1 BOTTLE	TABLET	100	21
68001-183-03	Quetiapine fumarate	500 in 1 BOTTLE	TABLET	500	21
68001-183-06	Quetiapine fumarate	60 in 1 BOTTLE	TABLET	60	21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68001-183-00	EA - Each	68001-183	92cae80b-8467-4391-8746-59fae14ea195	1	2014-06-03
68001-183-03	EA - Each	68001-183	119f41c0-b68a-4649-acaa-c2f6b3352c11	1	2014-06-03
68001-183-06	EA - Each	68001-183	4a8e3214-a0f5-4e21-8961-3820de360ad4	1	2014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
QUETIAPINE FUMARATE	ACTIVE INGREDIENT	2S3PL1B6UJ	QUETIAPINE FUMARATE TABLET [BLUEPOINT LABORATORIES]	4
QUETIAPINE	ACTIVE MOIETY	BGL0JSY5SI	QUETIAPINE FUMARATE TABLET [BLUEPOINT LABORATORIES]	4
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	QUETIAPINE FUMARATE TABLET [BLUEPOINT LABORATORIES]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	QUETIAPINE FUMARATE TABLET [BLUEPOINT LABORATORIES]	4
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	QUETIAPINE FUMARATE TABLET [BLUEPOINT LABORATORIES]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	QUETIAPINE FUMARATE TABLET [BLUEPOINT LABORATORIES]	4
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	QUETIAPINE FUMARATE TABLET [BLUEPOINT LABORATORIES]	4
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	QUETIAPINE FUMARATE TABLET [BLUEPOINT LABORATORIES]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	QUETIAPINE FUMARATE TABLET [BLUEPOINT LABORATORIES]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	QUETIAPINE FUMARATE TABLET [BLUEPOINT LABORATORIES]	4
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	QUETIAPINE FUMARATE TABLET [BLUEPOINT LABORATORIES]	4
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	QUETIAPINE FUMARATE TABLET [BLUEPOINT LABORATORIES]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	QUETIAPINE FUMARATE TABLET [BLUEPOINT LABORATORIES]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	QUETIAPINE FUMARATE TABLET [BLUEPOINT LABORATORIES]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68001-183	QUETIAPINE FUMARATE (QUETIAPINE) TABLET [BLUEPOINT LABORATORIES]	19	Current NDC, Legacy NDC, 3 package rows	20250410_874e50ad-5da0-4ac3-9290-79442c91399e.zip

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
312743	QUEtiapine fumarate 100 MG Oral Tablet	PSN	874e50ad-5da0-4ac3-9290-79442c91399e	21
317174	QUEtiapine fumarate 200 MG Oral Tablet	PSN	874e50ad-5da0-4ac3-9290-79442c91399e	21
312744	QUEtiapine fumarate 25 MG Oral Tablet	PSN	874e50ad-5da0-4ac3-9290-79442c91399e	21
312745	QUEtiapine fumarate 300 MG Oral Tablet	PSN	874e50ad-5da0-4ac3-9290-79442c91399e	21
616483	QUEtiapine fumarate 400 MG Oral Tablet	PSN	874e50ad-5da0-4ac3-9290-79442c91399e	21
616487	QUEtiapine fumarate 50 MG Oral Tablet	PSN	874e50ad-5da0-4ac3-9290-79442c91399e	21
312743	quetiapine 100 MG Oral Tablet	SCD	874e50ad-5da0-4ac3-9290-79442c91399e	21
317174	quetiapine 200 MG Oral Tablet	SCD	874e50ad-5da0-4ac3-9290-79442c91399e	21
312744	quetiapine 25 MG Oral Tablet	SCD	874e50ad-5da0-4ac3-9290-79442c91399e	21
312745	quetiapine 300 MG Oral Tablet	SCD	874e50ad-5da0-4ac3-9290-79442c91399e	21
616483	quetiapine 400 MG Oral Tablet	SCD	874e50ad-5da0-4ac3-9290-79442c91399e	21
616487	quetiapine 50 MG Oral Tablet	SCD	874e50ad-5da0-4ac3-9290-79442c91399e	21
312743	quetiapine (as quetiapine fumarate) 100 MG Oral Tablet	SY	874e50ad-5da0-4ac3-9290-79442c91399e	21
317174	quetiapine (as quetiapine fumarate) 200 MG Oral Tablet	SY	874e50ad-5da0-4ac3-9290-79442c91399e	21
312744	quetiapine (as quetiapine fumarate) 25 MG Oral Tablet	SY	874e50ad-5da0-4ac3-9290-79442c91399e	21
312745	quetiapine (as quetiapine fumarate) 300 MG Oral Tablet	SY	874e50ad-5da0-4ac3-9290-79442c91399e	21
616483	quetiapine (as quetiapine fumarate) 400 MG Oral Tablet	SY	874e50ad-5da0-4ac3-9290-79442c91399e	21
616487	quetiapine (as quetiapine fumarate) 50 MG Oral Tablet	SY	874e50ad-5da0-4ac3-9290-79442c91399e	21
312743	QUEtiapine fumarate 100 MG Oral Tablet	PSN	9f927ae2-a0ae-4953-99ba-8de59ee5bfca	7
317174	QUEtiapine fumarate 200 MG Oral Tablet	PSN	9f927ae2-a0ae-4953-99ba-8de59ee5bfca	7
312744	QUEtiapine fumarate 25 MG Oral Tablet	PSN	9f927ae2-a0ae-4953-99ba-8de59ee5bfca	7
312745	QUEtiapine fumarate 300 MG Oral Tablet	PSN	9f927ae2-a0ae-4953-99ba-8de59ee5bfca	7
616483	QUEtiapine fumarate 400 MG Oral Tablet	PSN	9f927ae2-a0ae-4953-99ba-8de59ee5bfca	7
616487	QUEtiapine fumarate 50 MG Oral Tablet	PSN	9f927ae2-a0ae-4953-99ba-8de59ee5bfca	7
312743	quetiapine 100 MG Oral Tablet	SCD	9f927ae2-a0ae-4953-99ba-8de59ee5bfca	7
317174	quetiapine 200 MG Oral Tablet	SCD	9f927ae2-a0ae-4953-99ba-8de59ee5bfca	7
312744	quetiapine 25 MG Oral Tablet	SCD	9f927ae2-a0ae-4953-99ba-8de59ee5bfca	7
312745	quetiapine 300 MG Oral Tablet	SCD	9f927ae2-a0ae-4953-99ba-8de59ee5bfca	7
616483	quetiapine 400 MG Oral Tablet	SCD	9f927ae2-a0ae-4953-99ba-8de59ee5bfca	7
616487	quetiapine 50 MG Oral Tablet	SCD	9f927ae2-a0ae-4953-99ba-8de59ee5bfca	7
312743	quetiapine (as quetiapine fumarate) 100 MG Oral Tablet	SY	9f927ae2-a0ae-4953-99ba-8de59ee5bfca	7
317174	quetiapine (as quetiapine fumarate) 200 MG Oral Tablet	SY	9f927ae2-a0ae-4953-99ba-8de59ee5bfca	7
312744	quetiapine (as quetiapine fumarate) 25 MG Oral Tablet	SY	9f927ae2-a0ae-4953-99ba-8de59ee5bfca	7
312745	quetiapine (as quetiapine fumarate) 300 MG Oral Tablet	SY	9f927ae2-a0ae-4953-99ba-8de59ee5bfca	7
616483	quetiapine (as quetiapine fumarate) 400 MG Oral Tablet	SY	9f927ae2-a0ae-4953-99ba-8de59ee5bfca	7
616487	quetiapine (as quetiapine fumarate) 50 MG Oral Tablet	SY	9f927ae2-a0ae-4953-99ba-8de59ee5bfca	7
312743	QUEtiapine fumarate 100 MG Oral Tablet	PSN	5a19e429-21d0-efd1-e053-2a91aa0acb63	1
317174	QUEtiapine fumarate 200 MG Oral Tablet	PSN	5a19e429-21d0-efd1-e053-2a91aa0acb63	1
312745	QUEtiapine fumarate 300 MG Oral Tablet	PSN	5a19e429-21d0-efd1-e053-2a91aa0acb63	1
312743	quetiapine 100 MG Oral Tablet	SCD	5a19e429-21d0-efd1-e053-2a91aa0acb63	1
317174	quetiapine 200 MG Oral Tablet	SCD	5a19e429-21d0-efd1-e053-2a91aa0acb63	1
312745	quetiapine 300 MG Oral Tablet	SCD	5a19e429-21d0-efd1-e053-2a91aa0acb63	1
312743	quetiapine (as quetiapine fumarate) 100 MG Oral Tablet	SY	5a19e429-21d0-efd1-e053-2a91aa0acb63	1
317174	quetiapine (as quetiapine fumarate) 200 MG Oral Tablet	SY	5a19e429-21d0-efd1-e053-2a91aa0acb63	1
312745	quetiapine (as quetiapine fumarate) 300 MG Oral Tablet	SY	5a19e429-21d0-efd1-e053-2a91aa0acb63	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68001-183-00	68001018300	100 TABLET in 1 BOTTLE (68001-183-00)	100 tablet	2013-02-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Quetiapine fumarate	Coupler LLC	2026-06-15	HUMAN PRESCRIPTION DRUG LABEL	1
Quetiapine fumarate	American Health Packaging	2026-05-21	HUMAN PRESCRIPTION DRUG LABEL	8
Quetiapine fumarate	BluePoint Laboratories \| Lupin Limited	2026-04-02	HUMAN PRESCRIPTION DRUG LABEL	21
Quetiapine fumarate	Contract Pharmacy Services-PA \| Coupler Enterprises Inc.	2017-09-26	HUMAN PRESCRIPTION DRUG LABEL	1