Quetiapine fumarate

Product NDC: 47335-906
11-digit product format: 473350906
Labeler code: 47335
Product ID: 47335-906_53310064-c86d-89f3-e063-6294a90a718b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Quetiapine fumarate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA201190
Marketing category: ANDA
Marketing start: 2012-03-28
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	47335-906	47335-906-18	D	Discontinued by firm		2026-10-15
excluded package	package	47335-906	47335-906-88	D	Discontinued by firm		2026-10-15

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	Approval date
A201190-001	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	2012-03-27
A201190-002	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	2012-03-27
A201190-003	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	2012-03-27
A201190-004	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	2012-03-27
A201190-005	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	2012-03-27
A201190-006	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	2012-03-27

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 7 · 264 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
2026-10-15 13:18:30	2026-09	A201190-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL		2012-03-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201190-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL		2012-03-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201190-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL		2012-03-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201190-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL		2012-03-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201190-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL		2012-03-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201190-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL		2012-03-27	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A201190-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL		2012-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201190-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201190-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201190-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL		2012-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201190-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201190-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL		2012-03-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201190-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL		2012-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201190-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201190-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201190-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL		2012-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201190-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201190-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL		2012-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201190-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201190-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201190-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201190-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL		2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201190-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201190-006	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	A201190-001	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	A201190-002	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	A201190-003	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	A201190-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL		2012-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201190-005	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	A201190-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201190-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201190-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201190-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201190-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201190-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201190-006	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	A201190-001	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	A201190-002	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	A201190-003	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	A201190-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 7 · 247 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201190-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201190-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201190-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201190-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201190-005	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201190-006	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201190-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201190-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201190-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201190-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201190-005	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201190-006	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201190-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201190-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201190-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201190-004	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201190-005	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201190-006	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201190-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201190-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201190-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201190-004	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201190-005	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201190-006	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201190-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201190-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201190-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201190-004	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201190-005	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201190-006	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201190-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201190-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201190-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201190-004	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201190-005	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201190-006	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201190-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201190-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201190-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201190-004	AB	1	`1e350fbaab3a…`

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 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
ffe52b98-9872-48c1-90fd-8fcd37c3432f	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
47335-906-18	Quetiapine fumarate	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	23
47335-906-61	Quetiapine fumarate	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	23
47335-906-61	Quetiapine fumarate	10 in 1 BOX, UNIT-DOSE	TABLET, FILM COATED	10	23
47335-906-83	Quetiapine fumarate	30 in 1 BOTTLE	TABLET, FILM COATED	30	23
47335-906-86	Quetiapine fumarate	60 in 1 BOTTLE	TABLET, FILM COATED	60	23
47335-906-88	Quetiapine fumarate	100 in 1 BOTTLE	TABLET, FILM COATED	100	23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
47335-906-18	EA - Each	47335-906	f31dc49f-1cf2-49ea-91fd-b370fb51c187	1	2012-07-24
47335-906-86	EA - Each	47335-906	fed40940-9f9b-4345-8b93-d3d74b0d9a97	1	2012-07-24
47335-906-88	EA - Each	47335-906	8162327b-99fa-4c58-a5a3-db8078ab8302	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 [SUN PHARMA GLOBAL FZE]	12
QUETIAPINE	ACTIVE MOIETY	BGL0JSY5SI	QUETIAPINE FUMARATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	12
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	QUETIAPINE FUMARATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	12
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	QUETIAPINE FUMARATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	12
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	QUETIAPINE FUMARATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	12
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	QUETIAPINE FUMARATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	12
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	QUETIAPINE FUMARATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	12
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	QUETIAPINE FUMARATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	12
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	QUETIAPINE FUMARATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	12
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	QUETIAPINE FUMARATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	12
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	QUETIAPINE FUMARATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	12
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	QUETIAPINE FUMARATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	12
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	QUETIAPINE FUMARATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	12
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	QUETIAPINE FUMARATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47335-906	QUETIAPINE FUMARATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]	23	Current NDC, Legacy NDC, 6 package rows	20250308_ffe52b98-9872-48c1-90fd-8fcd37c3432f.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Quetiapine fumarate	QUETIAPINE FUMARATE	Bryant Ranch Prepack	c52a9bff-8a03-44f5-9128-799c7dca0467	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201190 application number: ANDA201190
Quetiapine fumarate	QUETIAPINE FUMARATE	Bryant Ranch Prepack	3eb39b4e-4c79-43b9-a30e-b4221c0e2bd2	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201190 application number: ANDA201190
Quetiapine fumarate	QUETIAPINE FUMARATE	Sun Pharmaceutical Industries, Inc.	ffe52b98-9872-48c1-90fd-8fcd37c3432f	2026-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201190 application number: ANDA201190 ndc (product): 47335-906
Quetiapine fumarate	QUETIAPINE FUMARATE	Coupler LLC	258eac65-69ed-404f-e063-6394a90a19ef	2025-05-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201190 application number: ANDA201190
Quetiapine fumarate	QUETIAPINE FUMARATE	Bryant Ranch Prepack	9a024071-e620-48e8-9f22-d4cda5dc5ab1	2025-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201190 application number: ANDA201190

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2S3PL1B6UJ	QUETIAPINE FUMARATE	111974-72-2	QUETIAPINE FUMARATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312745	QUEtiapine fumarate 300 MG Oral Tablet	PSN	9a024071-e620-48e8-9f22-d4cda5dc5ab1	7
312745	quetiapine 300 MG Oral Tablet	SCD	9a024071-e620-48e8-9f22-d4cda5dc5ab1	7
312745	quetiapine (as quetiapine fumarate) 300 MG Oral Tablet	SY	9a024071-e620-48e8-9f22-d4cda5dc5ab1	7
312745	QUEtiapine fumarate 300 MG Oral Tablet	PSN	dfb4820d-d34f-2ddf-e053-2a95a90a9c21	1
312745	quetiapine 300 MG Oral Tablet	SCD	dfb4820d-d34f-2ddf-e053-2a95a90a9c21	1
312745	quetiapine (as quetiapine fumarate) 300 MG Oral Tablet	SY	dfb4820d-d34f-2ddf-e053-2a95a90a9c21	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
47335-906-18	47335090618	1000 TABLET, FILM COATED in 1 BOTTLE (47335-906-18)		2012-03-28	0000-00-00	No	No	Current
47335-906-61	47335090661	10 BLISTER PACK in 1 BOX, UNIT-DOSE (47335-906-61) / 10 TABLET, FILM COATED in 1 BLISTER PACK	10 blister pack	2012-03-28	0000-00-00	No	No	Current
47335-906-83	47335090683	30 TABLET, FILM COATED in 1 BOTTLE (47335-906-83)		2012-03-28	0000-00-00	No	No	Current
47335-906-86	47335090686	60 TABLET, FILM COATED in 1 BOTTLE (47335-906-86)		2012-03-28	0000-00-00	No	No	Current
47335-906-88	47335090688	100 TABLET, FILM COATED in 1 BOTTLE (47335-906-88)		2012-03-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Quetiapine fumarate	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Industries Limited	2026-06-01	HUMAN PRESCRIPTION DRUG LABEL	24
Quetiapine fumarate	Bryant Ranch Prepack	2025-04-24	HUMAN PRESCRIPTION DRUG LABEL	7
Quetiapine fumarate	Preferred Pharmaceuticals Inc.	2023-02-06	HUMAN PRESCRIPTION DRUG LABEL	1
Quetiapine fumarate	NuCare Pharmaceuticals,Inc.	2022-05-23	HUMAN PRESCRIPTION DRUG LABEL	1
Quetiapine fumarate	REMEDYREPACK INC.	2019-08-19	HUMAN PRESCRIPTION DRUG LABEL	3