Quetiapine

Product NDC: 0093-2063
11-digit product format: 000932063
Labeler code: 0093
Product ID: 0093-2063_5059f747-d59d-460b-99bc-7b76b235c094
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Quetiapine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA077745
Marketing category: ANDA
Marketing start: 2014-03-12
Substance: QUETIAPINE FUMARATE
Active strength: 25 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 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077745-001	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27
A077745-002	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27
A077745-003	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27
A077745-004	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-27
A077745-005	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27
A077745-006	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27
A077745-007	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 7 matching rows.

Application-product, TE code table
Application-product	TE code
A077745-001	AB
A077745-002	AB
A077745-003	AB
A077745-004	AB
A077745-005	AB
A077745-006	AB
A077745-007	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 8 · 287 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	A077745-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077745-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077745-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077745-004	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077745-005	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077745-006	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077745-007	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	A077745-001	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	A077745-002	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	A077745-003	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	A077745-004	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077745-005	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	A077745-006	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	A077745-007	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077745-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077745-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077745-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077745-004	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077745-005	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077745-006	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077745-007	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	A077745-001	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	A077745-002	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	A077745-003	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	A077745-004	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077745-005	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	A077745-006	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	A077745-007	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	A077745-001	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	A077745-002	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	A077745-003	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	A077745-004	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077745-005	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	A077745-006	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	A077745-007	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	A077745-001	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	A077745-002	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	A077745-003	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	A077745-004	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077745-005	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 287 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	A077745-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077745-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077745-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077745-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077745-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077745-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077745-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077745-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077745-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077745-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077745-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077745-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077745-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077745-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077745-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077745-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077745-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077745-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077745-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077745-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077745-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077745-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077745-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077745-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077745-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077745-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077745-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077745-007	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077745-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077745-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077745-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077745-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077745-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077745-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077745-007	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077745-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077745-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077745-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077745-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077745-005	AB	1	`03ed91905a0d…`

Additional Listing Data#

Finished product: Yes
Brand name base: Quetiapine
Listing expiration: 2027-12-31

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
c1d4ef59-bf58-44fe-9b46-1af42e2f7f8b	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	Strength	SPL version
0093-2063-01	Quetiapine	100 in 1 BOTTLE	TABLET, FILM COATED	100		19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-2063-01	EA - Each	0093-2063	0b8615e9-9cdc-405e-abab-b07c32b99d10	1	2014-04-03
0093-2063-10	EA - Each	0093-2063	809d9c33-0dc3-4055-9a3d-66081bce0b49	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
QUETIAPINE FUMARATE	ACTIVE INGREDIENT	2S3PL1B6UJ	QUETIAPINE FUMARATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
QUETIAPINE FUMARATE	ACTIVE INGREDIENT	2S3PL1B6UJ	QUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	4
QUETIAPINE FUMARATE	ACTIVE INGREDIENT	2S3PL1B6UJ	QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]	4
QUETIAPINE	ACTIVE MOIETY	BGL0JSY5SI	QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]	4
QUETIAPINE	ACTIVE MOIETY	BGL0JSY5SI	QUETIAPINE FUMARATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
QUETIAPINE	ACTIVE MOIETY	BGL0JSY5SI	QUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	4
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]	4
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	QUETIAPINE FUMARATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	QUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	4
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	QUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	4
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	QUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	QUETIAPINE FUMARATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	QUETIAPINE FUMARATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	QUETIAPINE FUMARATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	QUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	QUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	QUETIAPINE FUMARATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
HYPROMELLOSE 2910 (15 MPA.S)	INACTIVE INGREDIENT	36SFW2JZ0W	QUETIAPINE FUMARATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
HYPROMELLOSE 2910 (15 MPA.S)	INACTIVE INGREDIENT	36SFW2JZ0W	QUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	4
HYPROMELLOSE 2910 (15 MPA.S)	INACTIVE INGREDIENT	36SFW2JZ0W	QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]	4
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]	4
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	QUETIAPINE FUMARATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	QUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	4
HYPROMELLOSE 2910 (50 MPA.S)	INACTIVE INGREDIENT	1IVH67816N	QUETIAPINE FUMARATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
HYPROMELLOSE 2910 (50 MPA.S)	INACTIVE INGREDIENT	1IVH67816N	QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]	4
HYPROMELLOSE 2910 (50 MPA.S)	INACTIVE INGREDIENT	1IVH67816N	QUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	4
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]	4
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	QUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	4
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	QUETIAPINE FUMARATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	QUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	QUETIAPINE FUMARATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	QUETIAPINE FUMARATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	QUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]	4
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]	4
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	QUETIAPINE FUMARATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	QUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	4
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]	4
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	QUETIAPINE FUMARATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	QUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	4
POVIDONE K25	INACTIVE INGREDIENT	K0KQV10C35	QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]	4
POVIDONE K25	INACTIVE INGREDIENT	K0KQV10C35	QUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	4
POVIDONE K25	INACTIVE INGREDIENT	K0KQV10C35	QUETIAPINE FUMARATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
POVIDONE K26/28	INACTIVE INGREDIENT	H7AGY1OJO8	QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]	4
POVIDONE K26/28	INACTIVE INGREDIENT	H7AGY1OJO8	QUETIAPINE FUMARATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
POVIDONE K26/28	INACTIVE INGREDIENT	H7AGY1OJO8	QUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	QUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	QUETIAPINE FUMARATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	QUETIAPINE FUMARATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	QUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	QUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	QUETIAPINE FUMARATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]	4
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	QUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	4
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	QUETIAPINE FUMARATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0093-2063	QUETIAPINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]	18	Current NDC, Legacy NDC, 1 package rows	20250510_c1d4ef59-bf58-44fe-9b46-1af42e2f7f8b.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Quetiapine	QUETIAPINE	Teva Pharmaceuticals USA, Inc.	c1d4ef59-bf58-44fe-9b46-1af42e2f7f8b	2025-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077745 application number: ANDA077745 ndc (product): 0093-2063
Quetiapine	QUETIAPINE	Aphena Pharma Solutions - Tennessee, LLC	fdece055-aeb5-43d6-b730-54dd74bde304	2023-04-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077745 application number: ANDA077745
Quetiapine	QUETIAPINE	Proficient Rx LP	dd6b6088-943e-413b-9886-88dd9c622be4	2022-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077745 application number: ANDA077745
Quetiapine	QUETIAPINE	Proficient Rx LP	6258bbaf-4ac0-4621-b95e-e6b032aa0518	2020-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077745 application number: ANDA077745

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	c1d4ef59-bf58-44fe-9b46-1af42e2f7f8b	19
317174	QUEtiapine fumarate 200 MG Oral Tablet	PSN	c1d4ef59-bf58-44fe-9b46-1af42e2f7f8b	19
312744	QUEtiapine fumarate 25 MG Oral Tablet	PSN	c1d4ef59-bf58-44fe-9b46-1af42e2f7f8b	19
312745	QUEtiapine fumarate 300 MG Oral Tablet	PSN	c1d4ef59-bf58-44fe-9b46-1af42e2f7f8b	19
616483	QUEtiapine fumarate 400 MG Oral Tablet	PSN	c1d4ef59-bf58-44fe-9b46-1af42e2f7f8b	19
616487	QUEtiapine fumarate 50 MG Oral Tablet	PSN	c1d4ef59-bf58-44fe-9b46-1af42e2f7f8b	19
312743	quetiapine 100 MG Oral Tablet	SCD	c1d4ef59-bf58-44fe-9b46-1af42e2f7f8b	19
317174	quetiapine 200 MG Oral Tablet	SCD	c1d4ef59-bf58-44fe-9b46-1af42e2f7f8b	19
312744	quetiapine 25 MG Oral Tablet	SCD	c1d4ef59-bf58-44fe-9b46-1af42e2f7f8b	19
312745	quetiapine 300 MG Oral Tablet	SCD	c1d4ef59-bf58-44fe-9b46-1af42e2f7f8b	19
616483	quetiapine 400 MG Oral Tablet	SCD	c1d4ef59-bf58-44fe-9b46-1af42e2f7f8b	19
616487	quetiapine 50 MG Oral Tablet	SCD	c1d4ef59-bf58-44fe-9b46-1af42e2f7f8b	19
312743	quetiapine (as quetiapine fumarate) 100 MG Oral Tablet	SY	c1d4ef59-bf58-44fe-9b46-1af42e2f7f8b	19
317174	quetiapine (as quetiapine fumarate) 200 MG Oral Tablet	SY	c1d4ef59-bf58-44fe-9b46-1af42e2f7f8b	19
312744	quetiapine (as quetiapine fumarate) 25 MG Oral Tablet	SY	c1d4ef59-bf58-44fe-9b46-1af42e2f7f8b	19
312745	quetiapine (as quetiapine fumarate) 300 MG Oral Tablet	SY	c1d4ef59-bf58-44fe-9b46-1af42e2f7f8b	19
616483	quetiapine (as quetiapine fumarate) 400 MG Oral Tablet	SY	c1d4ef59-bf58-44fe-9b46-1af42e2f7f8b	19
616487	quetiapine (as quetiapine fumarate) 50 MG Oral Tablet	SY	c1d4ef59-bf58-44fe-9b46-1af42e2f7f8b	19
312743	QUEtiapine fumarate 100 MG Oral Tablet	PSN	8a3fc038-aad1-6404-6ead-a4a55127cf43	12
317174	QUEtiapine fumarate 200 MG Oral Tablet	PSN	8a3fc038-aad1-6404-6ead-a4a55127cf43	12
312744	QUEtiapine fumarate 25 MG Oral Tablet	PSN	8a3fc038-aad1-6404-6ead-a4a55127cf43	12
312745	QUEtiapine fumarate 300 MG Oral Tablet	PSN	8a3fc038-aad1-6404-6ead-a4a55127cf43	12
616483	QUEtiapine fumarate 400 MG Oral Tablet	PSN	8a3fc038-aad1-6404-6ead-a4a55127cf43	12
616487	QUEtiapine fumarate 50 MG Oral Tablet	PSN	8a3fc038-aad1-6404-6ead-a4a55127cf43	12
312743	quetiapine 100 MG Oral Tablet	SCD	8a3fc038-aad1-6404-6ead-a4a55127cf43	12
317174	quetiapine 200 MG Oral Tablet	SCD	8a3fc038-aad1-6404-6ead-a4a55127cf43	12
312744	quetiapine 25 MG Oral Tablet	SCD	8a3fc038-aad1-6404-6ead-a4a55127cf43	12
312745	quetiapine 300 MG Oral Tablet	SCD	8a3fc038-aad1-6404-6ead-a4a55127cf43	12
616483	quetiapine 400 MG Oral Tablet	SCD	8a3fc038-aad1-6404-6ead-a4a55127cf43	12
616487	quetiapine 50 MG Oral Tablet	SCD	8a3fc038-aad1-6404-6ead-a4a55127cf43	12
312743	quetiapine (as quetiapine fumarate) 100 MG Oral Tablet	SY	8a3fc038-aad1-6404-6ead-a4a55127cf43	12
317174	quetiapine (as quetiapine fumarate) 200 MG Oral Tablet	SY	8a3fc038-aad1-6404-6ead-a4a55127cf43	12
312744	quetiapine (as quetiapine fumarate) 25 MG Oral Tablet	SY	8a3fc038-aad1-6404-6ead-a4a55127cf43	12
312745	quetiapine (as quetiapine fumarate) 300 MG Oral Tablet	SY	8a3fc038-aad1-6404-6ead-a4a55127cf43	12
616483	quetiapine (as quetiapine fumarate) 400 MG Oral Tablet	SY	8a3fc038-aad1-6404-6ead-a4a55127cf43	12
616487	quetiapine (as quetiapine fumarate) 50 MG Oral Tablet	SY	8a3fc038-aad1-6404-6ead-a4a55127cf43	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0093-2063-01	00093206301	100 TABLET, FILM COATED in 1 BOTTLE (0093-2063-01)	2014-03-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Quetiapine	AvKARE	2026-01-15	HUMAN PRESCRIPTION DRUG LABEL	12
Quetiapine	Teva Pharmaceuticals USA, Inc.	2025-08-04	HUMAN PRESCRIPTION DRUG LABEL	19
Quetiapine Fumarate	NCS HealthCare of KY, Inc dba Vangard Labs	2016-01-25	HUMAN PRESCRIPTION DRUG LABEL	7