Quetiapine

Product NDC: 67877-246
11-digit product format: 678770246
Labeler code: 67877
Product ID: 67877-246_1324eb95-6488-498f-b2c9-1c44b1f48062
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Quetiapine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Ascend Laboratories, LLC
Application: ANDA201504
Marketing category: ANDA
Marketing start: 2013-03-01
Substance: QUETIAPINE FUMARATE
Active strength: 200 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 43.

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
A201504-001	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2013-02-12
A201504-002	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2013-02-12
A201504-003	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2013-02-12
A201504-004	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2013-02-12
A201504-005	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2013-02-12
A201504-006	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2013-02-12
A201504-007	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2013-02-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201504-001	AB
A201504-002	AB
A201504-003	AB
A201504-004	AB
A201504-005	AB
A201504-006	AB
A201504-007	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 · 301 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
2026-09-14 22:38:34	2026-08	A201504-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2013-02-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201504-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2013-02-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201504-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2013-02-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201504-004	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2013-02-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201504-005	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2013-02-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201504-006	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2013-02-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201504-007	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2013-02-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201504-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2013-02-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201504-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2013-02-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201504-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2013-02-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201504-004	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2013-02-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201504-005	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2013-02-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201504-006	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2013-02-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201504-007	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2013-02-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201504-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2013-02-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201504-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2013-02-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201504-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2013-02-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201504-004	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2013-02-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201504-005	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2013-02-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201504-006	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2013-02-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201504-007	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2013-02-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201504-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2013-02-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201504-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2013-02-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201504-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2013-02-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201504-004	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2013-02-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201504-005	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2013-02-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201504-006	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2013-02-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201504-007	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2013-02-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201504-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2013-02-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201504-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2013-02-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201504-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2013-02-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201504-004	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2013-02-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201504-005	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2013-02-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201504-006	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2013-02-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201504-007	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2013-02-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201504-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2013-02-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201504-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2013-02-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201504-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2013-02-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201504-004	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2013-02-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201504-005	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2013-02-12	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 301 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A201504-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201504-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201504-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201504-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201504-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201504-006	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201504-007	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201504-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201504-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201504-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201504-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201504-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201504-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201504-007	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201504-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201504-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201504-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201504-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201504-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201504-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201504-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201504-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201504-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201504-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201504-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201504-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201504-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201504-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201504-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201504-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201504-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201504-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201504-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201504-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201504-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201504-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201504-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201504-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201504-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201504-005	AB	1	`fd3edfee7708…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
QUETIAPINE FUMARATE	200 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 · 7 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
389201	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
3112a006-1c61-47f2-84f5-9a7670d09c9b	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
67877-246-01	Quetiapine	100 in 1 BOTTLE	TABLET, FILM COATED	100	40
67877-246-10	Quetiapine	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	40
67877-246-33	Quetiapine	1 in 1 CARTON	TABLET, FILM COATED	1	40
67877-246-33	Quetiapine	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	40
67877-246-38	Quetiapine	10 in 1 CARTON	TABLET, FILM COATED	10	40
67877-246-38	Quetiapine	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	40

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67877-246-01	EA - Each	67877-246	b11cf044-de50-48c3-a0c3-767826be85dd	1	2013-03-03
67877-246-10	EA - Each	67877-246	adeec331-f19c-463e-bb78-769c3e64e67a	1	2015-08-04
67877-246-33	EA - Each	67877-246	21740c79-0dbf-4003-9cc7-83f9533b17b5	1	2013-04-01
67877-246-38	EA - Each	67877-246	c1a581fc-97a3-45eb-aafc-701b7eb95fd1	1	2013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
QUETIAPINE FUMARATE	ACTIVE INGREDIENT	2S3PL1B6UJ	QUETIAPINE FUMARATE TABLET QUETIAPINE FUMARATE (QUETIAPINE FUMARATE ) TABLET [ASCEND LABORATORIES, LLC]	18
QUETIAPINE	ACTIVE MOIETY	BGL0JSY5SI	QUETIAPINE FUMARATE TABLET QUETIAPINE FUMARATE (QUETIAPINE FUMARATE ) TABLET [ASCEND LABORATORIES, LLC]	18
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	QUETIAPINE FUMARATE TABLET QUETIAPINE FUMARATE (QUETIAPINE FUMARATE ) TABLET [ASCEND LABORATORIES, LLC]	18
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	QUETIAPINE FUMARATE TABLET QUETIAPINE FUMARATE (QUETIAPINE FUMARATE ) TABLET [ASCEND LABORATORIES, LLC]	18
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	QUETIAPINE FUMARATE TABLET QUETIAPINE FUMARATE (QUETIAPINE FUMARATE ) TABLET [ASCEND LABORATORIES, LLC]	18
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	QUETIAPINE FUMARATE TABLET QUETIAPINE FUMARATE (QUETIAPINE FUMARATE ) TABLET [ASCEND LABORATORIES, LLC]	18
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	QUETIAPINE FUMARATE TABLET QUETIAPINE FUMARATE (QUETIAPINE FUMARATE ) TABLET [ASCEND LABORATORIES, LLC]	18
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	QUETIAPINE FUMARATE TABLET QUETIAPINE FUMARATE (QUETIAPINE FUMARATE ) TABLET [ASCEND LABORATORIES, LLC]	18
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	QUETIAPINE FUMARATE TABLET QUETIAPINE FUMARATE (QUETIAPINE FUMARATE ) TABLET [ASCEND LABORATORIES, LLC]	18
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	QUETIAPINE FUMARATE TABLET QUETIAPINE FUMARATE (QUETIAPINE FUMARATE ) TABLET [ASCEND LABORATORIES, LLC]	18
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	QUETIAPINE FUMARATE TABLET QUETIAPINE FUMARATE (QUETIAPINE FUMARATE ) TABLET [ASCEND LABORATORIES, LLC]	18
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	QUETIAPINE FUMARATE TABLET QUETIAPINE FUMARATE (QUETIAPINE FUMARATE ) TABLET [ASCEND LABORATORIES, LLC]	18
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	QUETIAPINE FUMARATE TABLET QUETIAPINE FUMARATE (QUETIAPINE FUMARATE ) TABLET [ASCEND LABORATORIES, LLC]	18
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	QUETIAPINE FUMARATE TABLET QUETIAPINE FUMARATE (QUETIAPINE FUMARATE ) TABLET [ASCEND LABORATORIES, LLC]	18
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	QUETIAPINE FUMARATE TABLET QUETIAPINE FUMARATE (QUETIAPINE FUMARATE ) TABLET [ASCEND LABORATORIES, LLC]	18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67877-246	QUETIAPINE TABLET, FILM COATED [ASCEND LABORATORIES, LLC]	40	Current NDC, Legacy NDC, 6 package rows	20250524_3112a006-1c61-47f2-84f5-9a7670d09c9b.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 2 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Quetiapine Fumarate	QUETIAPINE FUMARATE	Proficient Rx LP	392dd5cf-4777-4985-b62b-7370134dee26	2024-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201504 application number: ANDA201504
Quetiapine Fumarate	QUETIAPINE FUMARATE	A-S Medication Solutions	ccacb909-8ee5-4223-bfee-9cfeae470ecf	2023-11-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201504 application number: ANDA201504
Quetiapine Fumarate	QUETIAPINE FUMARATE	Proficient Rx LP	85f973e0-93e6-4856-9266-62136acb2532	2023-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201504 application number: ANDA201504
Quetiapine Fumarate	QUETIAPINE FUMARATE	A-S Medication Solutions	95156201-ed16-4806-98a7-d42acc902126	2023-06-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201504 application number: ANDA201504
Quetiapine Fumarate	QUETIAPINE FUMARATE	Proficient Rx LP	c1f2ccba-62f3-44e7-b06f-dea61eac9e93	2023-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201504 application number: ANDA201504
Quetiapine Fumarate	QUETIAPINE FUMARATE	Proficient Rx LP	03517f29-f270-4350-a57a-fbe1967b0096	2019-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201504 application number: ANDA201504

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
317174	QUEtiapine fumarate 200 MG Oral Tablet	PSN	35b2069e-209a-41ac-84e6-377d4f19be87	105
317174	quetiapine 200 MG Oral Tablet	SCD	35b2069e-209a-41ac-84e6-377d4f19be87	105
317174	quetiapine (as quetiapine fumarate) 200 MG Oral Tablet	SY	35b2069e-209a-41ac-84e6-377d4f19be87	105
312743	QUEtiapine fumarate 100 MG Oral Tablet	PSN	3112a006-1c61-47f2-84f5-9a7670d09c9b	40
389201	QUEtiapine fumarate 150 MG Oral Tablet	PSN	3112a006-1c61-47f2-84f5-9a7670d09c9b	40
317174	QUEtiapine fumarate 200 MG Oral Tablet	PSN	3112a006-1c61-47f2-84f5-9a7670d09c9b	40
312744	QUEtiapine fumarate 25 MG Oral Tablet	PSN	3112a006-1c61-47f2-84f5-9a7670d09c9b	40
312745	QUEtiapine fumarate 300 MG Oral Tablet	PSN	3112a006-1c61-47f2-84f5-9a7670d09c9b	40
616483	QUEtiapine fumarate 400 MG Oral Tablet	PSN	3112a006-1c61-47f2-84f5-9a7670d09c9b	40
616487	QUEtiapine fumarate 50 MG Oral Tablet	PSN	3112a006-1c61-47f2-84f5-9a7670d09c9b	40
312743	quetiapine 100 MG Oral Tablet	SCD	3112a006-1c61-47f2-84f5-9a7670d09c9b	40
389201	quetiapine 150 MG Oral Tablet	SCD	3112a006-1c61-47f2-84f5-9a7670d09c9b	40
317174	quetiapine 200 MG Oral Tablet	SCD	3112a006-1c61-47f2-84f5-9a7670d09c9b	40
312744	quetiapine 25 MG Oral Tablet	SCD	3112a006-1c61-47f2-84f5-9a7670d09c9b	40
312745	quetiapine 300 MG Oral Tablet	SCD	3112a006-1c61-47f2-84f5-9a7670d09c9b	40
616483	quetiapine 400 MG Oral Tablet	SCD	3112a006-1c61-47f2-84f5-9a7670d09c9b	40
616487	quetiapine 50 MG Oral Tablet	SCD	3112a006-1c61-47f2-84f5-9a7670d09c9b	40
312743	quetiapine (as quetiapine fumarate) 100 MG Oral Tablet	SY	3112a006-1c61-47f2-84f5-9a7670d09c9b	40
389201	quetiapine (as quetiapine fumarate) 150 MG Oral Tablet	SY	3112a006-1c61-47f2-84f5-9a7670d09c9b	40
317174	quetiapine (as quetiapine fumarate) 200 MG Oral Tablet	SY	3112a006-1c61-47f2-84f5-9a7670d09c9b	40
312744	quetiapine (as quetiapine fumarate) 25 MG Oral Tablet	SY	3112a006-1c61-47f2-84f5-9a7670d09c9b	40
312745	quetiapine (as quetiapine fumarate) 300 MG Oral Tablet	SY	3112a006-1c61-47f2-84f5-9a7670d09c9b	40
616483	quetiapine (as quetiapine fumarate) 400 MG Oral Tablet	SY	3112a006-1c61-47f2-84f5-9a7670d09c9b	40
616487	quetiapine (as quetiapine fumarate) 50 MG Oral Tablet	SY	3112a006-1c61-47f2-84f5-9a7670d09c9b	40
317174	QUEtiapine fumarate 200 MG Oral Tablet	PSN	10288afa-c4dc-4897-9ec8-f4573d850779	19
317174	quetiapine 200 MG Oral Tablet	SCD	10288afa-c4dc-4897-9ec8-f4573d850779	19
317174	quetiapine (as quetiapine fumarate) 200 MG Oral Tablet	SY	10288afa-c4dc-4897-9ec8-f4573d850779	19
312743	QUEtiapine fumarate 100 MG Oral Tablet	PSN	f9447739-9e21-4232-950f-174c0496ab66	8
317174	QUEtiapine fumarate 200 MG Oral Tablet	PSN	f9447739-9e21-4232-950f-174c0496ab66	8
312744	QUEtiapine fumarate 25 MG Oral Tablet	PSN	f9447739-9e21-4232-950f-174c0496ab66	8
312745	QUEtiapine fumarate 300 MG Oral Tablet	PSN	f9447739-9e21-4232-950f-174c0496ab66	8
616483	QUEtiapine fumarate 400 MG Oral Tablet	PSN	f9447739-9e21-4232-950f-174c0496ab66	8
616487	QUEtiapine fumarate 50 MG Oral Tablet	PSN	f9447739-9e21-4232-950f-174c0496ab66	8
312743	quetiapine 100 MG Oral Tablet	SCD	f9447739-9e21-4232-950f-174c0496ab66	8
317174	quetiapine 200 MG Oral Tablet	SCD	f9447739-9e21-4232-950f-174c0496ab66	8
312744	quetiapine 25 MG Oral Tablet	SCD	f9447739-9e21-4232-950f-174c0496ab66	8
312745	quetiapine 300 MG Oral Tablet	SCD	f9447739-9e21-4232-950f-174c0496ab66	8
616483	quetiapine 400 MG Oral Tablet	SCD	f9447739-9e21-4232-950f-174c0496ab66	8
616487	quetiapine 50 MG Oral Tablet	SCD	f9447739-9e21-4232-950f-174c0496ab66	8
312743	quetiapine (as quetiapine fumarate) 100 MG Oral Tablet	SY	f9447739-9e21-4232-950f-174c0496ab66	8
317174	quetiapine (as quetiapine fumarate) 200 MG Oral Tablet	SY	f9447739-9e21-4232-950f-174c0496ab66	8
312744	quetiapine (as quetiapine fumarate) 25 MG Oral Tablet	SY	f9447739-9e21-4232-950f-174c0496ab66	8
312745	quetiapine (as quetiapine fumarate) 300 MG Oral Tablet	SY	f9447739-9e21-4232-950f-174c0496ab66	8
616483	quetiapine (as quetiapine fumarate) 400 MG Oral Tablet	SY	f9447739-9e21-4232-950f-174c0496ab66	8
616487	quetiapine (as quetiapine fumarate) 50 MG Oral Tablet	SY	f9447739-9e21-4232-950f-174c0496ab66	8
312743	QUEtiapine fumarate 100 MG Oral Tablet	PSN	74e09734-26cb-42fe-b9a3-79cc10505e0b	1
389201	QUEtiapine fumarate 150 MG Oral Tablet	PSN	74e09734-26cb-42fe-b9a3-79cc10505e0b	1
317174	QUEtiapine fumarate 200 MG Oral Tablet	PSN	74e09734-26cb-42fe-b9a3-79cc10505e0b	1
312744	QUEtiapine fumarate 25 MG Oral Tablet	PSN	74e09734-26cb-42fe-b9a3-79cc10505e0b	1
312745	QUEtiapine fumarate 300 MG Oral Tablet	PSN	74e09734-26cb-42fe-b9a3-79cc10505e0b	1
616483	QUEtiapine fumarate 400 MG Oral Tablet	PSN	74e09734-26cb-42fe-b9a3-79cc10505e0b	1
616487	QUEtiapine fumarate 50 MG Oral Tablet	PSN	74e09734-26cb-42fe-b9a3-79cc10505e0b	1
312743	quetiapine 100 MG Oral Tablet	SCD	74e09734-26cb-42fe-b9a3-79cc10505e0b	1
389201	quetiapine 150 MG Oral Tablet	SCD	74e09734-26cb-42fe-b9a3-79cc10505e0b	1
317174	quetiapine 200 MG Oral Tablet	SCD	74e09734-26cb-42fe-b9a3-79cc10505e0b	1
312744	quetiapine 25 MG Oral Tablet	SCD	74e09734-26cb-42fe-b9a3-79cc10505e0b	1
312745	quetiapine 300 MG Oral Tablet	SCD	74e09734-26cb-42fe-b9a3-79cc10505e0b	1
616483	quetiapine 400 MG Oral Tablet	SCD	74e09734-26cb-42fe-b9a3-79cc10505e0b	1
616487	quetiapine 50 MG Oral Tablet	SCD	74e09734-26cb-42fe-b9a3-79cc10505e0b	1
312743	quetiapine (as quetiapine fumarate) 100 MG Oral Tablet	SY	74e09734-26cb-42fe-b9a3-79cc10505e0b	1
389201	quetiapine (as quetiapine fumarate) 150 MG Oral Tablet	SY	74e09734-26cb-42fe-b9a3-79cc10505e0b	1
317174	quetiapine (as quetiapine fumarate) 200 MG Oral Tablet	SY	74e09734-26cb-42fe-b9a3-79cc10505e0b	1
312744	quetiapine (as quetiapine fumarate) 25 MG Oral Tablet	SY	74e09734-26cb-42fe-b9a3-79cc10505e0b	1
312745	quetiapine (as quetiapine fumarate) 300 MG Oral Tablet	SY	74e09734-26cb-42fe-b9a3-79cc10505e0b	1
616483	quetiapine (as quetiapine fumarate) 400 MG Oral Tablet	SY	74e09734-26cb-42fe-b9a3-79cc10505e0b	1
616487	quetiapine (as quetiapine fumarate) 50 MG Oral Tablet	SY	74e09734-26cb-42fe-b9a3-79cc10505e0b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67877-246-01	67877024601	100 TABLET, FILM COATED in 1 BOTTLE (67877-246-01)		2013-03-01	0000-00-00	No	No	Current
67877-246-10	67877024610	1000 TABLET, FILM COATED in 1 BOTTLE (67877-246-10)		2013-03-01	0000-00-00	No	No	Current
67877-246-33	67877024633	1 BLISTER PACK in 1 CARTON (67877-246-33) / 10 TABLET, FILM COATED in 1 BLISTER PACK	1 blister pack	2013-03-01	0000-00-00	No	No	Current
67877-246-38	67877024638	10 BLISTER PACK in 1 CARTON (67877-246-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK	10 blister pack	2013-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Quetiapine	Major Pharmaceuticals	2026-09-17	HUMAN PRESCRIPTION DRUG LABEL	9
Quetiapine	Ascend Laboratories, LLC \| Alkem Laboratories Limited	2026-08-06	Human Prescription Drug Label	42
Quetiapine Fumarate	A-S Medication Solutions	2025-12-18	Human Prescription Drug Label	19
Quetiapine	ASCLEMED USA INC. \| ASCLEMED USA INC. DBA ENOVACHEM	2025-10-20	HUMAN PRESCRIPTION DRUG LABEL	1
Quetiapine Fumarate	Bryant Ranch Prepack	2025-04-29	HUMAN PRESCRIPTION DRUG LABEL	105
Quetiapine Fumarate	REMEDYREPACK INC.	2024-02-14	HUMAN PRESCRIPTION DRUG LABEL	9
Quetiapine Fumarate	REMEDYREPACK INC.	2024-01-05	HUMAN PRESCRIPTION DRUG LABEL	9