Quetiapine

Product NDC: 16729-146
11-digit product format: 167290146
Labeler code: 16729
Product ID: 16729-146_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: 50 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	50 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
16729-146-01	Quetiapine	100 in 1 BOTTLE	TABLET, FILM COATED	100	17
16729-146-10	Quetiapine	30 in 1 BOTTLE	TABLET, FILM COATED	30	17
16729-146-17	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
16729-146-01	EA - Each	16729-146	ddf8b2a0-32e3-4eda-853a-1fe43b6bfd26	1	2012-07-24
16729-146-10	EA - Each	16729-146	98472581-3d20-4b49-bf7e-8c992c74e91c	1	2013-02-13
16729-146-17	EA - Each	16729-146	a7459c0c-8f60-45c9-a9bc-98e269d07f65	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 [BRYANT RANCH PREPACK]	1001
QUETIAPINE	ACTIVE MOIETY	BGL0JSY5SI	QUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	QUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	QUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	QUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	QUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	QUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	QUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	QUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	QUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	QUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
QUETIAPINE FUMARATE	ACTIVE INGREDIENT	2S3PL1B6UJ	QUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	5
QUETIAPINE	ACTIVE MOIETY	BGL0JSY5SI	QUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	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 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 (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
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	QUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	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
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	QUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	QUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	5
QUETIAPINE FUMARATE	ACTIVE INGREDIENT	2S3PL1B6UJ	QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]	2
QUETIAPINE	ACTIVE MOIETY	BGL0JSY5SI	QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]	2
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]	2
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]	2
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]	2
QUETIAPINE FUMARATE	ACTIVE INGREDIENT	2S3PL1B6UJ	QUETIAPINE FUMARATE TABLET, FILM COATED [STAT RX USA LLC]	1
QUETIAPINE FUMARATE	ACTIVE INGREDIENT	2S3PL1B6UJ	QUETIAPINE FUMARATE TABLET, FILM COATED [DIRECT RX]	1
QUETIAPINE	ACTIVE MOIETY	BGL0JSY5SI	QUETIAPINE FUMARATE TABLET, FILM COATED [DIRECT RX]	1
QUETIAPINE	ACTIVE MOIETY	BGL0JSY5SI	QUETIAPINE FUMARATE TABLET, FILM COATED [STAT RX USA LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	QUETIAPINE FUMARATE TABLET, FILM COATED [STAT RX USA LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	QUETIAPINE FUMARATE TABLET, FILM COATED [DIRECT RX]	1
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	QUETIAPINE FUMARATE TABLET, FILM COATED [DIRECT RX]	1
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	QUETIAPINE FUMARATE TABLET, FILM COATED [STAT RX USA LLC]	1
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	QUETIAPINE FUMARATE TABLET, FILM COATED [DIRECT RX]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	QUETIAPINE FUMARATE TABLET, FILM COATED [STAT RX USA LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	QUETIAPINE FUMARATE TABLET, FILM COATED [DIRECT RX]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	QUETIAPINE FUMARATE TABLET, FILM COATED [STAT RX USA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	QUETIAPINE FUMARATE TABLET, FILM COATED [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	QUETIAPINE FUMARATE TABLET, FILM COATED [STAT RX USA LLC]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	QUETIAPINE FUMARATE TABLET, FILM COATED [STAT RX USA LLC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	QUETIAPINE FUMARATE TABLET, FILM COATED [DIRECT RX]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	QUETIAPINE FUMARATE TABLET, FILM COATED [DIRECT RX]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	QUETIAPINE FUMARATE TABLET, FILM COATED [STAT RX USA LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	QUETIAPINE FUMARATE TABLET, FILM COATED [DIRECT RX]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	QUETIAPINE FUMARATE TABLET, FILM COATED [STAT RX USA LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	QUETIAPINE FUMARATE TABLET, FILM COATED [STAT RX USA LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	QUETIAPINE FUMARATE TABLET, FILM COATED [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16729-146	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
616487	QUEtiapine fumarate 50 MG Oral Tablet	PSN	a45d8b77-f13d-41c5-8d50-15152fc6f85c	1010
616487	quetiapine 50 MG Oral Tablet	SCD	a45d8b77-f13d-41c5-8d50-15152fc6f85c	1010
616487	quetiapine (as quetiapine fumarate) 50 MG Oral Tablet	SY	a45d8b77-f13d-41c5-8d50-15152fc6f85c	1010
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
312743	QUEtiapine fumarate 100 MG Oral Tablet	PSN	8048ac0a-5d4d-4d00-ab9c-7fcac27f0a60	7
616487	QUEtiapine fumarate 50 MG Oral Tablet	PSN	8048ac0a-5d4d-4d00-ab9c-7fcac27f0a60	7
312743	quetiapine 100 MG Oral Tablet	SCD	8048ac0a-5d4d-4d00-ab9c-7fcac27f0a60	7
616487	quetiapine 50 MG Oral Tablet	SCD	8048ac0a-5d4d-4d00-ab9c-7fcac27f0a60	7
312743	quetiapine (as quetiapine fumarate) 100 MG Oral Tablet	SY	8048ac0a-5d4d-4d00-ab9c-7fcac27f0a60	7
616487	quetiapine (as quetiapine fumarate) 50 MG Oral Tablet	SY	8048ac0a-5d4d-4d00-ab9c-7fcac27f0a60	7
616487	QUEtiapine fumarate 50 MG Oral Tablet	PSN	14827341-d940-493f-9598-2d129436b5ec	5
616487	quetiapine 50 MG Oral Tablet	SCD	14827341-d940-493f-9598-2d129436b5ec	5
616487	quetiapine (as quetiapine fumarate) 50 MG Oral Tablet	SY	14827341-d940-493f-9598-2d129436b5ec	5
616487	QUEtiapine fumarate 50 MG Oral Tablet	PSN	87222d90-dfd4-4a57-e053-2991aa0aed86	2
616487	quetiapine 50 MG Oral Tablet	SCD	87222d90-dfd4-4a57-e053-2991aa0aed86	2
616487	quetiapine (as quetiapine fumarate) 50 MG Oral Tablet	SY	87222d90-dfd4-4a57-e053-2991aa0aed86	2
616487	QUEtiapine fumarate 50 MG Oral Tablet	PSN	8ffc5526-f535-462b-b216-7df27d630c42	1
616487	QUEtiapine fumarate 50 MG Oral Tablet	PSN	a480fe5d-68e0-471c-85cf-a9824bd7a0ae	1
616487	QUEtiapine fumarate 50 MG Oral Tablet	PSN	a90798e4-2600-407a-e053-2a95a90a3df7	1
616487	quetiapine 50 MG Oral Tablet	SCD	8ffc5526-f535-462b-b216-7df27d630c42	1
616487	quetiapine 50 MG Oral Tablet	SCD	a480fe5d-68e0-471c-85cf-a9824bd7a0ae	1
616487	quetiapine 50 MG Oral Tablet	SCD	a90798e4-2600-407a-e053-2a95a90a3df7	1
616487	quetiapine (as quetiapine fumarate) 50 MG Oral Tablet	SY	8ffc5526-f535-462b-b216-7df27d630c42	1
616487	quetiapine (as quetiapine fumarate) 50 MG Oral Tablet	SY	a480fe5d-68e0-471c-85cf-a9824bd7a0ae	1
616487	quetiapine (as quetiapine fumarate) 50 MG Oral Tablet	SY	a90798e4-2600-407a-e053-2a95a90a3df7	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16729-146-01	16729014601	100 TABLET, FILM COATED in 1 BOTTLE (16729-146-01)	2012-03-28	0000-00-00	No	No	Current
16729-146-10	16729014610	30 in 1 BOTTLE					Historical
16729-146-17	16729014617	1000 TABLET, FILM COATED in 1 BOTTLE (16729-146-17)	2012-03-28	0000-00-00	No	No	Current
16729-146-22	16729014622	5000 TABLET, FILM COATED in 1 CONTAINER (16729-146-22)	16-DEC-15				Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
QUETIAPINE FUMARATE	Bryant Ranch Prepack	2026-04-02	HUMAN PRESCRIPTION DRUG LABEL	1010
Quetiapine	Accord Healthcare Inc. \| Intas Pharmaceuticals Limited	2025-11-14	HUMAN PRESCRIPTION DRUG LABEL	17
Quetiapine	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	5
Quetiapine fumarate	Proficient Rx LP	2022-05-02	HUMAN PRESCRIPTION DRUG LABEL	7
Quetiapine	Contract Pharmacy Services-PA \| Coupler Enterprises Inc.	2020-06-26	HUMAN PRESCRIPTION DRUG LABEL	1
Quetiapine	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2019-12-06	HUMAN PRESCRIPTION DRUG LABEL	2
QUETIAPINE FUMARATE	Direct RX	2015-07-02	HUMAN PRESCRIPTION DRUG LABEL	1
QUETIAPINE FUMARATE	STAT Rx USA LLC \| PSS World Medical Inc.	2012-05-08	HUMAN PRESCRIPTION DRUG LABEL	1

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#