Quetiapine Fumarate

Product NDC
0310-8284
11-digit product format
003108284
Labeler code
0310
Product ID
0310-8284_403797ba-33a5-4b31-a1ca-ef756e655625
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine Fumarate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
AstraZeneca Pharmaceuticals LP
Application
NDA022047
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2017-05-01
Marketing end
2021-02-28
Substance
QUETIAPINE FUMARATE
Active strength
400 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0310-8284DDiscontinued by firm2026-08-03
excluded packagepackage0310-82840310-8284-60DDiscontinued by firm2026-08-03

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0310-8284-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0310-8284-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0310-8284-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0310-8284-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0310-8284-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0310-8284-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0310-8284-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0310-8284-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0310-8284-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0310-8284-60ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0310-8284-60367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0310-8284-60557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022047-001SEROQUEL XRQUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALABRLD2007-05-17
N022047-002SEROQUEL XRQUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2007-05-17
N022047-003SEROQUEL XRQUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALABRLD2007-05-17
N022047-004SEROQUEL XRQUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALABRLD2007-05-17
N022047-005SEROQUEL XRQUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-08-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
N022047-001AB
N022047-002AB
N022047-003AB
N022047-004AB
N022047-005AB

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 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022047-001SEROQUEL XREQ 50MG BASETABLET, EXTENDED RELEASE / ORALABRLD2007-05-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022047-002SEROQUEL XREQ 200MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2007-05-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022047-003SEROQUEL XREQ 300MG BASETABLET, EXTENDED RELEASE / ORALABRLD2007-05-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022047-004SEROQUEL XREQ 400MG BASETABLET, EXTENDED RELEASE / ORALABRLD2007-05-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022047-005SEROQUEL XREQ 150MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-08-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022047-001SEROQUEL XREQ 50MG BASETABLET, EXTENDED RELEASE / ORALABRLD2007-05-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022047-002SEROQUEL XREQ 200MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2007-05-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022047-003SEROQUEL XREQ 300MG BASETABLET, EXTENDED RELEASE / ORALABRLD2007-05-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022047-004SEROQUEL XREQ 400MG BASETABLET, EXTENDED RELEASE / ORALABRLD2007-05-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022047-005SEROQUEL XREQ 150MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-08-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08N022047-001SEROQUEL XREQ 50MG BASETABLET, EXTENDED RELEASE / ORALABRLD2007-05-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022047-002SEROQUEL XREQ 200MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2007-05-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022047-003SEROQUEL XREQ 300MG BASETABLET, EXTENDED RELEASE / ORALABRLD2007-05-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022047-004SEROQUEL XREQ 400MG BASETABLET, EXTENDED RELEASE / ORALABRLD2007-05-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022047-005SEROQUEL XREQ 150MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-08-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022047-001SEROQUEL XREQ 50MG BASETABLET, EXTENDED RELEASE / ORALABRLD2007-05-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022047-002SEROQUEL XREQ 200MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2007-05-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022047-003SEROQUEL XREQ 300MG BASETABLET, EXTENDED RELEASE / ORALABRLD2007-05-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022047-004SEROQUEL XREQ 400MG BASETABLET, EXTENDED RELEASE / ORALABRLD2007-05-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022047-005SEROQUEL XREQ 150MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-08-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022047-001SEROQUEL XREQ 50MG BASETABLET, EXTENDED RELEASE / ORALABRLD2007-05-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022047-002SEROQUEL XREQ 200MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2007-05-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022047-003SEROQUEL XREQ 300MG BASETABLET, EXTENDED RELEASE / ORALABRLD2007-05-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022047-004SEROQUEL XREQ 400MG BASETABLET, EXTENDED RELEASE / ORALABRLD2007-05-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022047-005SEROQUEL XREQ 150MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-08-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022047-001SEROQUEL XREQ 50MG BASETABLET, EXTENDED RELEASE / ORALABRLD2007-05-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022047-002SEROQUEL XREQ 200MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2007-05-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022047-003SEROQUEL XREQ 300MG BASETABLET, EXTENDED RELEASE / ORALABRLD2007-05-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022047-004SEROQUEL XREQ 400MG BASETABLET, EXTENDED RELEASE / ORALABRLD2007-05-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022047-005SEROQUEL XREQ 150MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-08-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022047-001SEROQUEL XREQ 50MG BASETABLET, EXTENDED RELEASE / ORALABRLD2007-05-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022047-002SEROQUEL XREQ 200MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2007-05-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022047-003SEROQUEL XREQ 300MG BASETABLET, EXTENDED RELEASE / ORALABRLD2007-05-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022047-004SEROQUEL XREQ 400MG BASETABLET, EXTENDED RELEASE / ORALABRLD2007-05-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022047-005SEROQUEL XREQ 150MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-08-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022047-001SEROQUEL XREQ 50MG BASETABLET, EXTENDED RELEASE / ORALABRLD2007-05-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022047-002SEROQUEL XREQ 200MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2007-05-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022047-003SEROQUEL XREQ 300MG BASETABLET, EXTENDED RELEASE / ORALABRLD2007-05-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022047-004SEROQUEL XREQ 400MG BASETABLET, EXTENDED RELEASE / ORALABRLD2007-05-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022047-005SEROQUEL XREQ 150MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-08-115bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N022047-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022047-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022047-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022047-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022047-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022047-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022047-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022047-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022047-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022047-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N022047-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022047-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022047-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022047-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022047-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022047-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022047-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022047-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022047-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022047-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022047-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022047-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022047-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022047-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022047-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022047-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022047-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022047-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022047-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022047-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022047-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022047-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022047-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022047-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022047-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022047-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022047-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022047-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022047-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022047-005AB15bbf6a4d5a75…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0310-8284-60EA - Each0310-8284440f8a40-13c1-4b36-b2c2-31db6d3bbe1312017-06-15

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SEROQUEL XRQUETIAPINEH2-Pharma, LLCab959a35-d0ba-4f18-8f2e-6619d88b16e32026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022047
application number: NDA022047
SEROQUEL XRQUETIAPINEAstraZeneca Pharmaceuticals LP473a3ac4-67f4-4782-baa9-7f9bdd8761f42025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022047
application number: NDA022047

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0310-8284-600031082846060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0310-8284-60) 2017-05-012021-02-28NoNoCurrent