Quetiapine

Product NDC: 16729-145
11-digit product format: 167290145
Labeler code: 16729
Product ID: 16729-145_438f950d-730b-8926-e063-6294a90a8f66
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Quetiapine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Accord Healthcare Inc.
Application: ANDA202152
Marketing category: ANDA
Marketing start: 2012-03-28
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
QUETIAPINE FUMARATE	25 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	2S3PL1B6UJ
Rxcui	312743, 312744, 312745, 317174, 616483, 616487

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
16729-145-01	Quetiapine	100 in 1 BOTTLE	TABLET, FILM COATED	100	17
16729-145-10	Quetiapine	30 in 1 BOTTLE	TABLET, FILM COATED	30	17
16729-145-17	Quetiapine	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16729-145-01	EA - Each	16729-145	49446579-a065-4c5e-8065-71a5228d4a26	1	2012-07-24
16729-145-10	EA - Each	16729-145	f441b569-fa30-486c-a53d-bb9bcdd7c847	1	2013-02-13
16729-145-17	EA - Each	16729-145	dd3eed5e-8499-4e41-b48b-b11fe05cdf8e	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, FILM COATED [ACCORD HEALTHCARE INC.]	5
QUETIAPINE FUMARATE	ACTIVE INGREDIENT	2S3PL1B6UJ	QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]	5
QUETIAPINE	ACTIVE MOIETY	BGL0JSY5SI	QUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	5
QUETIAPINE	ACTIVE MOIETY	BGL0JSY5SI	QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]	5
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	QUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	5
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	QUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	5
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	QUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	5
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]	5
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]	5
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	QUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	5
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	QUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	5
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]	5
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]	5
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	QUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	QUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	QUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	QUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	5
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	QUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	5
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]	5
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	QUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	5
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	QUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]	5
QUETIAPINE FUMARATE	ACTIVE INGREDIENT	2S3PL1B6UJ	QUETIAPINE FUMARATE TABLET, FILM COATED [UNIT DOSE SERVICES]	3
QUETIAPINE	ACTIVE MOIETY	BGL0JSY5SI	QUETIAPINE FUMARATE TABLET, FILM COATED [UNIT DOSE SERVICES]	3
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	QUETIAPINE FUMARATE TABLET, FILM COATED [UNIT DOSE SERVICES]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	QUETIAPINE FUMARATE TABLET, FILM COATED [UNIT DOSE SERVICES]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	QUETIAPINE FUMARATE TABLET, FILM COATED [UNIT DOSE SERVICES]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	QUETIAPINE FUMARATE TABLET, FILM COATED [UNIT DOSE SERVICES]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	QUETIAPINE FUMARATE TABLET, FILM COATED [UNIT DOSE SERVICES]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	QUETIAPINE FUMARATE TABLET, FILM COATED [UNIT DOSE SERVICES]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	QUETIAPINE FUMARATE TABLET, FILM COATED [UNIT DOSE SERVICES]	3
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	QUETIAPINE FUMARATE TABLET, FILM COATED [UNIT DOSE SERVICES]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	QUETIAPINE FUMARATE TABLET, FILM COATED [UNIT DOSE SERVICES]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	QUETIAPINE FUMARATE TABLET, FILM COATED [UNIT DOSE SERVICES]	3
QUETIAPINE FUMARATE	ACTIVE INGREDIENT	2S3PL1B6UJ	QUETIAPINE FUMARATE TABLET, FILM COATED [DIRECT RX]	2
QUETIAPINE	ACTIVE MOIETY	BGL0JSY5SI	QUETIAPINE FUMARATE TABLET, FILM COATED [DIRECT RX]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	QUETIAPINE FUMARATE TABLET, FILM COATED [DIRECT RX]	2
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	QUETIAPINE FUMARATE TABLET, FILM COATED [DIRECT RX]	2
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	QUETIAPINE FUMARATE TABLET, FILM COATED [DIRECT RX]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	QUETIAPINE FUMARATE TABLET, FILM COATED [DIRECT RX]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	QUETIAPINE FUMARATE TABLET, FILM COATED [DIRECT RX]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	QUETIAPINE FUMARATE TABLET, FILM COATED [DIRECT RX]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	QUETIAPINE FUMARATE TABLET, FILM COATED [DIRECT RX]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	QUETIAPINE FUMARATE TABLET, FILM COATED [DIRECT RX]	2
QUETIAPINE FUMARATE	ACTIVE INGREDIENT	2S3PL1B6UJ	QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]	1
QUETIAPINE	ACTIVE MOIETY	BGL0JSY5SI	QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]	1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16729-145	QUETIAPINE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	16	Current NDC, Legacy NDC, 3 package rows	20240719_2d77412a-e084-4406-ac33-d882aece9354.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	2d77412a-e084-4406-ac33-d882aece9354	17
317174	QUEtiapine fumarate 200 MG Oral Tablet	PSN	2d77412a-e084-4406-ac33-d882aece9354	17
312744	QUEtiapine fumarate 25 MG Oral Tablet	PSN	2d77412a-e084-4406-ac33-d882aece9354	17
312745	QUEtiapine fumarate 300 MG Oral Tablet	PSN	2d77412a-e084-4406-ac33-d882aece9354	17
616483	QUEtiapine fumarate 400 MG Oral Tablet	PSN	2d77412a-e084-4406-ac33-d882aece9354	17
616487	QUEtiapine fumarate 50 MG Oral Tablet	PSN	2d77412a-e084-4406-ac33-d882aece9354	17
312743	quetiapine 100 MG Oral Tablet	SCD	2d77412a-e084-4406-ac33-d882aece9354	17
317174	quetiapine 200 MG Oral Tablet	SCD	2d77412a-e084-4406-ac33-d882aece9354	17
312744	quetiapine 25 MG Oral Tablet	SCD	2d77412a-e084-4406-ac33-d882aece9354	17
312745	quetiapine 300 MG Oral Tablet	SCD	2d77412a-e084-4406-ac33-d882aece9354	17
616483	quetiapine 400 MG Oral Tablet	SCD	2d77412a-e084-4406-ac33-d882aece9354	17
616487	quetiapine 50 MG Oral Tablet	SCD	2d77412a-e084-4406-ac33-d882aece9354	17
312743	quetiapine (as quetiapine fumarate) 100 MG Oral Tablet	SY	2d77412a-e084-4406-ac33-d882aece9354	17
317174	quetiapine (as quetiapine fumarate) 200 MG Oral Tablet	SY	2d77412a-e084-4406-ac33-d882aece9354	17
312744	quetiapine (as quetiapine fumarate) 25 MG Oral Tablet	SY	2d77412a-e084-4406-ac33-d882aece9354	17
312745	quetiapine (as quetiapine fumarate) 300 MG Oral Tablet	SY	2d77412a-e084-4406-ac33-d882aece9354	17
616483	quetiapine (as quetiapine fumarate) 400 MG Oral Tablet	SY	2d77412a-e084-4406-ac33-d882aece9354	17
616487	quetiapine (as quetiapine fumarate) 50 MG Oral Tablet	SY	2d77412a-e084-4406-ac33-d882aece9354	17
317174	QUEtiapine fumarate 200 MG Oral Tablet	PSN	aef8ce93-52bf-4df9-8e49-5ad33bef7cef	15
312744	QUEtiapine fumarate 25 MG Oral Tablet	PSN	aef8ce93-52bf-4df9-8e49-5ad33bef7cef	15
616483	QUEtiapine fumarate 400 MG Oral Tablet	PSN	aef8ce93-52bf-4df9-8e49-5ad33bef7cef	15
317174	quetiapine 200 MG Oral Tablet	SCD	aef8ce93-52bf-4df9-8e49-5ad33bef7cef	15
312744	quetiapine 25 MG Oral Tablet	SCD	aef8ce93-52bf-4df9-8e49-5ad33bef7cef	15
616483	quetiapine 400 MG Oral Tablet	SCD	aef8ce93-52bf-4df9-8e49-5ad33bef7cef	15
317174	quetiapine (as quetiapine fumarate) 200 MG Oral Tablet	SY	aef8ce93-52bf-4df9-8e49-5ad33bef7cef	15
312744	quetiapine (as quetiapine fumarate) 25 MG Oral Tablet	SY	aef8ce93-52bf-4df9-8e49-5ad33bef7cef	15
616483	quetiapine (as quetiapine fumarate) 400 MG Oral Tablet	SY	aef8ce93-52bf-4df9-8e49-5ad33bef7cef	15
312744	QUEtiapine fumarate 25 MG Oral Tablet	PSN	85bdb3a6-3129-4f8b-95b9-a7559d9b911c	11
312744	quetiapine 25 MG Oral Tablet	SCD	85bdb3a6-3129-4f8b-95b9-a7559d9b911c	11
312744	quetiapine (as quetiapine fumarate) 25 MG Oral Tablet	SY	85bdb3a6-3129-4f8b-95b9-a7559d9b911c	11
312743	QUEtiapine fumarate 100 MG Oral Tablet	PSN	5dd65e85-430b-4e25-bfe0-5b4c332c39c0	6
312744	QUEtiapine fumarate 25 MG Oral Tablet	PSN	5dd65e85-430b-4e25-bfe0-5b4c332c39c0	6
312743	quetiapine 100 MG Oral Tablet	SCD	5dd65e85-430b-4e25-bfe0-5b4c332c39c0	6
312744	quetiapine 25 MG Oral Tablet	SCD	5dd65e85-430b-4e25-bfe0-5b4c332c39c0	6
312743	quetiapine (as quetiapine fumarate) 100 MG Oral Tablet	SY	5dd65e85-430b-4e25-bfe0-5b4c332c39c0	6
312744	quetiapine (as quetiapine fumarate) 25 MG Oral Tablet	SY	5dd65e85-430b-4e25-bfe0-5b4c332c39c0	6
317174	QUEtiapine fumarate 200 MG Oral Tablet	PSN	4cb7490f-3496-4710-a5fb-85778c8a6e24	5
312744	QUEtiapine fumarate 25 MG Oral Tablet	PSN	1a147d6c-8af8-4379-8a13-1864a9a79b84	5
312744	QUEtiapine fumarate 25 MG Oral Tablet	PSN	4cb7490f-3496-4710-a5fb-85778c8a6e24	5
317174	quetiapine 200 MG Oral Tablet	SCD	4cb7490f-3496-4710-a5fb-85778c8a6e24	5
312744	quetiapine 25 MG Oral Tablet	SCD	4cb7490f-3496-4710-a5fb-85778c8a6e24	5
312744	quetiapine 25 MG Oral Tablet	SCD	1a147d6c-8af8-4379-8a13-1864a9a79b84	5
317174	quetiapine (as quetiapine fumarate) 200 MG Oral Tablet	SY	4cb7490f-3496-4710-a5fb-85778c8a6e24	5
312744	quetiapine (as quetiapine fumarate) 25 MG Oral Tablet	SY	4cb7490f-3496-4710-a5fb-85778c8a6e24	5
312744	quetiapine (as quetiapine fumarate) 25 MG Oral Tablet	SY	1a147d6c-8af8-4379-8a13-1864a9a79b84	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16729-145-01	16729014501	100 TABLET, FILM COATED in 1 BOTTLE (16729-145-01)	2012-03-28	0000-00-00	No	No	Current
16729-145-10	16729014510	30 in 1 BOTTLE					Historical
16729-145-17	16729014517	1000 TABLET, FILM COATED in 1 BOTTLE (16729-145-17)	2012-03-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Quetiapine	Accord Healthcare Inc. \| Intas Pharmaceuticals Limited	2025-11-14	HUMAN PRESCRIPTION DRUG LABEL	17
QUETIAPINE FUMARATE	Direct_Rx	2023-03-10	HUMAN PRESCRIPTION DRUG LABEL	11
Quetiapine fumarate	Proficient Rx LP	2022-10-01	HUMAN PRESCRIPTION DRUG LABEL	5
Quetiapine	A-S Medication Solutions	2021-08-19	HUMAN PRESCRIPTION DRUG LABEL	15
QUETIAPINE FUMARATE	Unit Dose Services	2017-07-28	HUMAN PRESCRIPTION DRUG LABEL	6
Quetiapine fumarate	TYA Pharmaceuticals	2014-05-21	HUMAN PRESCRIPTION DRUG LABEL	5

Quetiapine

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#