Quetiapine

Product NDC: 16729-146
Requested package NDC: 16729-146-22
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished package	package	16729-146	16729-146-22	UNFINISHED	Active or certified unfinished drug listing		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 21 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	`5b2001dcd8f5…`	`54b53d4dc9e4…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	TE codes	Approval date
A202152-001	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27
A202152-002	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27
A202152-003	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27
A202152-004	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27
A202152-005	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27
A202152-006	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A202152-001	AB
A202152-002	AB
A202152-003	AB
A202152-004	AB
A202152-005	AB
A202152-006	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 7 · 246 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	A202152-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202152-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202152-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202152-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202152-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202152-006	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	A202152-001	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	A202152-002	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	A202152-003	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	A202152-004	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	A202152-005	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	A202152-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202152-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202152-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202152-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202152-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202152-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202152-006	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	A202152-001	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	A202152-002	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	A202152-003	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	A202152-004	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	A202152-005	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	A202152-006	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	A202152-001	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	A202152-002	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	A202152-003	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	A202152-004	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	A202152-005	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	A202152-006	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	A202152-001	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	A202152-002	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	A202152-003	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	A202152-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202152-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202152-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202152-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202152-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202152-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202152-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 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	A202152-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202152-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202152-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202152-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202152-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202152-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202152-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202152-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202152-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202152-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202152-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202152-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202152-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202152-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202152-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202152-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202152-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202152-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202152-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202152-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202152-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202152-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202152-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202152-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202152-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202152-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202152-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202152-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202152-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202152-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202152-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202152-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202152-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202152-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202152-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202152-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202152-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202152-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202152-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202152-004	AB	1	`2680178bc6a6…`

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 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
2d77412a-e084-4406-ac33-d882aece9354	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
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

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Quetiapine	QUETIAPINE	Bryant Ranch Prepack	cb989abf-7d73-4ab9-a07f-a8c9de50389f	2026-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202152 application number: ANDA202152
QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	Bryant Ranch Prepack	a45d8b77-f13d-41c5-8d50-15152fc6f85c	2026-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202152 application number: ANDA202152
QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	Bryant Ranch Prepack	4e1e5249-1cb7-4cc2-ad5a-cdeeee2f494f	2026-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202152 application number: ANDA202152
QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	Bryant Ranch Prepack	45c4c3a4-3acc-413e-9746-4816d513fac6	2026-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202152 application number: ANDA202152
Quetiapine	QUETIAPINE	Accord Healthcare Inc.	2d77412a-e084-4406-ac33-d882aece9354	2025-11-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202152 application number: ANDA202152 ndc (product): 16729-146
Quetiapine	QUETIAPINE	Proficient Rx LP	7a090720-fd90-4976-9aa2-41812106eb70	2022-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202152 application number: ANDA202152
Quetiapine fumarate	QUETIAPINE FUMARATE	Proficient Rx LP	1a147d6c-8af8-4379-8a13-1864a9a79b84	2022-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202152 application number: ANDA202152
Quetiapine fumarate	QUETIAPINE FUMARATE	Proficient Rx LP	8048ac0a-5d4d-4d00-ab9c-7fcac27f0a60	2022-05-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202152 application number: ANDA202152

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	Status
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	Preferred Pharmaceuticals Inc.	2024-08-05	HUMAN PRESCRIPTION DRUG LABEL	6
Quetiapine	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	5
Quetiapine	NCS HealthCare of KY, LLC dba Vangard Labs	2023-02-09	HUMAN PRESCRIPTION DRUG LABEL	9
Quetiapine	REMEDYREPACK INC.	2022-06-16	HUMAN PRESCRIPTION DRUG LABEL	8
Quetiapine fumarate	Proficient Rx LP	2022-05-02	HUMAN PRESCRIPTION DRUG LABEL	7
Quetiapine	REMEDYREPACK INC.	2021-12-15	HUMAN PRESCRIPTION DRUG LABEL	8
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	NuCare Pharmaceuticals,Inc.	2018-01-19	HUMAN PRESCRIPTION DRUG LABEL	1
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