Quetiapine Fumarate

Product NDC: 72189-477
11-digit product format: 721890477
Labeler code: 72189
Product ID: 72189-477_2c4e047c-e102-db6f-e063-6394a90ac37a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Quetiapine Fumarate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Direct_Rx
Application: ANDA091388
Marketing category: ANDA
Marketing start: 2023-05-30
Substance: QUETIAPINE FUMARATE
Active strength: 400 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 4 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product	72189-477		U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-477	72189-477-30	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	72189-477		U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-477	72189-477-30	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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
A091388-001	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27
A091388-002	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27
A091388-003	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27
A091388-004	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-27
A091388-005	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27
A091388-006	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27
A091388-007	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
A091388-001	AB
A091388-002	AB
A091388-003	AB
A091388-004	AB
A091388-005	AB
A091388-006	AB
A091388-007	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	A091388-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091388-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091388-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091388-004	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091388-005	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091388-006	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091388-007	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	A091388-001	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	A091388-002	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	A091388-003	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	A091388-004	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	A091388-005	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	A091388-006	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	A091388-007	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091388-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091388-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091388-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091388-004	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091388-005	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091388-006	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091388-007	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	A091388-001	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	A091388-002	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	A091388-003	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	A091388-004	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	A091388-005	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	A091388-006	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	A091388-007	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	A091388-001	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	A091388-002	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	A091388-003	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	A091388-004	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	A091388-005	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	A091388-006	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	A091388-007	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	A091388-001	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	A091388-002	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	A091388-003	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	A091388-004	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	A091388-005	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	A091388-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091388-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091388-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091388-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091388-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091388-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091388-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091388-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091388-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091388-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091388-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091388-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091388-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091388-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091388-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091388-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091388-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091388-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091388-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091388-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091388-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091388-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091388-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091388-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091388-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091388-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091388-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091388-007	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091388-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091388-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091388-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091388-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091388-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091388-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091388-007	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091388-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091388-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091388-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091388-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091388-005	AB	1	`03ed91905a0d…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Quetiapine Fumarate	QUETIAPINE FUMARATE	NorthStar Rx LLC	e6e25ef9-2671-489e-8eca-58bedb4f59ab	2026-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091388 application number: ANDA091388
Quetiapine Fumarate	QUETIAPINE FUMARATE	REMEDYREPACK INC.	b90390d8-6ebc-48b3-8b4d-6a3ff7d19ef6	2026-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091388 application number: ANDA091388
Quetiapine Fumarate	QUETIAPINE FUMARATE	Bryant Ranch Prepack	58541ffd-58c3-49aa-ad90-7e91a3c0b7d6	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091388 application number: ANDA091388
Quetiapine Fumarate	QUETIAPINE FUMARATE	Bryant Ranch Prepack	d3dcfb51-e67d-44dc-9186-4729f6414bf1	2026-05-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091388 application number: ANDA091388
Quetiapine Fumarate	QUETIAPINE FUMARATE	Bryant Ranch Prepack	aa0d27fd-569a-4573-b45d-2de5f5a30294	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091388 application number: ANDA091388
Quetiapine Fumarate	QUETIAPINE FUMARATE	Bryant Ranch Prepack	897184b1-de3c-4d59-91be-3069325fd5b2	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091388 application number: ANDA091388
Quetiapine Fumarate	QUETIAPINE FUMARATE	REMEDYREPACK INC.	da5c118f-404c-4453-aa10-a8656b1d7501	2026-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091388 application number: ANDA091388
Quetiapine Fumarate	QUETIAPINE FUMARATE	REMEDYREPACK INC.	911bf26c-a89a-4ce1-8ff5-cfda03d0a482	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091388 application number: ANDA091388
Quetiapine Fumarate	QUETIAPINE FUMARATE	Bryant Ranch Prepack	f0ad842c-a0c2-4855-a55b-353b5338980f	2026-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091388 application number: ANDA091388
Quetiapine Fumarate	QUETIAPINE FUMARATE	REMEDYREPACK INC.	41dbd5a5-4ae2-4ac1-8135-0fdac5c170b5	2026-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091388 application number: ANDA091388
Quetiapine Fumarate	QUETIAPINE FUMARATE	A-S Medication Solutions	55018271-1f8f-4683-afee-8203c3bd9acc	2026-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091388 application number: ANDA091388
Quetiapine Fumarate	QUETIAPINE FUMARATE	Rising Pharma Holdings, Inc.	532c8ace-4cf5-4a08-bae7-2af8c41ffa3d	2025-10-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091388 application number: ANDA091388
Quetiapine Fumarate	QUETIAPINE FUMARATE	Bryant Ranch Prepack	49ebd00b-e0a2-45c3-9cff-4b94d1a6b5ad	2025-09-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091388 application number: ANDA091388
Quetiapine Fumarate	QUETIAPINE FUMARATE	Aurobindo Pharma Limited	8df82f5a-aa0e-4f8c-bae1-2f32ede3d7b6	2025-09-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091388 application number: ANDA091388
Quetiapine Fumarate	QUETIAPINE FUMARATE	Preferred Pharmaceuticals Inc.	951a098a-d905-4723-89e1-71bf1551dcb6	2025-04-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091388 application number: ANDA091388
Quetiapine Fumarate	QUETIAPINE FUMARATE	Direct_Rx	face6c19-3dd9-b188-e053-6294a90a62d0	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091388 application number: ANDA091388
Quetiapine Fumarate	QUETIAPINE FUMARATE	Direct_Rx	fceb9f47-8da7-7138-e053-6294a90a5558	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091388 application number: ANDA091388 ndc (product): 72189-477
Quetiapine Fumarate	QUETIAPINE FUMARATE	Preferred Pharmaceuticals Inc.	8acc0ed3-6e4f-4799-8252-5a163938fddc	2025-01-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091388 application number: ANDA091388
Quetiapine Fumarate	QUETIAPINE FUMARATE	NuCare Pharmaceuticals,Inc.	0fdbe32f-d04a-5666-e063-6294a90a8e36	2024-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091388 application number: ANDA091388
Quetiapine Fumarate	QUETIAPINE FUMARATE	Proficient Rx LP	2b387188-c2c1-4865-984c-341a358d1c6c	2023-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091388 application number: ANDA091388

Additional Listing Data#

Finished product: Yes
Brand name base: Quetiapine Fumarate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
QUETIAPINE FUMARATE	400 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
616483	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
fceb9f47-8da7-7138-e053-6294a90a5558	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
72189-477-30	Quetiapine Fumarate	30 in 1 BOTTLE	TABLET, FILM COATED	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-477-30	EA - Each	72189-477	27561416-278d-4ecc-ba39-dd281eec0fc5	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-477	QUETIAPINE FUMARATE TABLET, FILM COATED [DIRECT_RX]	2	Current NDC, 1 package rows	20250123_fceb9f47-8da7-7138-e053-6294a90a5558.zip

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
616483	QUEtiapine fumarate 400 MG Oral Tablet	PSN	fceb9f47-8da7-7138-e053-6294a90a5558	2
616483	quetiapine 400 MG Oral Tablet	SCD	fceb9f47-8da7-7138-e053-6294a90a5558	2
616483	quetiapine (as quetiapine fumarate) 400 MG Oral Tablet	SY	fceb9f47-8da7-7138-e053-6294a90a5558	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72189-477-30	72189047730	30 TABLET, FILM COATED in 1 BOTTLE (72189-477-30)	2023-05-30	No	No	Current