SEROQUEL

Product NDC
0310-0283
11-digit product format
003100283
Labeler code
0310
Product ID
0310-0283_8e78eabf-6ff9-409b-ba1b-d9cb8d4f3fe0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
quetiapine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
AstraZeneca Pharmaceuticals LP
Application
NDA022047
Marketing category
NDA
Marketing start
2007-07-16
Marketing end
2027-01-31
Substance
QUETIAPINE FUMARATE
Active strength
300 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0310-02830310-0283-39DDiscontinued by firm2026-08-03
excluded packagepackage0310-02830310-0283-55DDiscontinued by firm2026-08-03
excluded packagepackage0310-02830310-0283-94DDiscontinued 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 · 36 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-050310-0283-94d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050310-0283-39d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050310-0283-55d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-260310-0283-94f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260310-0283-39f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260310-0283-55f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-310310-0283-942ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-310310-0283-392ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-310310-0283-552ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-280310-0283-94a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-280310-0283-39a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-280310-0283-55a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-210310-0283-94cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-210310-0283-39cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-210310-0283-55cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-100310-0283-39cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-100310-0283-55cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-100310-0283-94cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-310310-0283-39302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-310310-0283-55302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-310310-0283-94302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-200310-0283-39ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-200310-0283-55ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-200310-0283-94ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100310-0283-390efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-100310-0283-550efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-100310-0283-940efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-080310-0283-39ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-080310-0283-94ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-080310-0283-55ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-030310-0283-39367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-030310-0283-94367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-030310-0283-55367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-090310-0283-39557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-090310-0283-94557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-090310-0283-55557ba5c1ecfa…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…

Additional Listing Data#

Finished product
Yes
Brand name base
SEROQUEL
Brand name suffix
XR

Active Ingredients#

Ingredient, Strength table
IngredientStrength
QUETIAPINE FUMARATE300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2S3PL1B6UJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
721791Internal RxNorm lookup
721793Internal RxNorm lookup
721794Internal RxNorm lookup
721795Internal RxNorm lookup
721796Internal RxNorm lookup
721797Internal RxNorm lookup
853201Internal RxNorm lookup
853202Internal RxNorm lookup
895670Internal RxNorm lookup
895671Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
473a3ac4-67f4-4782-baa9-7f9bdd8761f4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5ef42f82-f087-0d2c-105f-f791ca69210eProduct name820250729
21205abd-8c89-4943-9f85-908f3d4fc3bbProduct name520230501
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0310-0283-39SEROQUELXR10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1047
0310-0283-39SEROQUELXR10 in 1 CARTONTABLET, EXTENDED RELEASE1047
0310-0283-55SEROQUELXR500 in 1 BOTTLETABLET, EXTENDED RELEASE50047
0310-0283-60SEROQUELXR60 in 1 BOTTLETABLET, EXTENDED RELEASE6047
0310-0283-94SEROQUELXR4 in 1 BOTTLETABLET, EXTENDED RELEASE447

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0310-0283-39EA - Each0310-0283c2fc269b-f5ea-4ba8-9e0e-dba81315949012012-07-24
0310-0283-60EA - Each0310-02830e6bf425-635a-485a-a6f6-de6baf19351812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
QUETIAPINE FUMARATEACTIVE INGREDIENT2S3PL1B6UJSEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE SEROQUEL XR (QUETIAPINE FUMARATE) KIT [ASTRAZENECA PHARMACEUTICALS LP]30
QUETIAPINEACTIVE MOIETYBGL0JSY5SISEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE SEROQUEL XR (QUETIAPINE FUMARATE) KIT [ASTRAZENECA PHARMACEUTICALS LP]30
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE SEROQUEL XR (QUETIAPINE FUMARATE) KIT [ASTRAZENECA PHARMACEUTICALS LP]30
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE SEROQUEL XR (QUETIAPINE FUMARATE) KIT [ASTRAZENECA PHARMACEUTICALS LP]30
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE SEROQUEL XR (QUETIAPINE FUMARATE) KIT [ASTRAZENECA PHARMACEUTICALS LP]30
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE SEROQUEL XR (QUETIAPINE FUMARATE) KIT [ASTRAZENECA PHARMACEUTICALS LP]30
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE SEROQUEL XR (QUETIAPINE FUMARATE) KIT [ASTRAZENECA PHARMACEUTICALS LP]30
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE SEROQUEL XR (QUETIAPINE FUMARATE) KIT [ASTRAZENECA PHARMACEUTICALS LP]30
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQSEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE SEROQUEL XR (QUETIAPINE FUMARATE) KIT [ASTRAZENECA PHARMACEUTICALS LP]30
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95SEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE SEROQUEL XR (QUETIAPINE FUMARATE) KIT [ASTRAZENECA PHARMACEUTICALS LP]30
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRSEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE SEROQUEL XR (QUETIAPINE FUMARATE) KIT [ASTRAZENECA PHARMACEUTICALS LP]30
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE SEROQUEL XR (QUETIAPINE FUMARATE) KIT [ASTRAZENECA PHARMACEUTICALS LP]30
WATERINACTIVE INGREDIENT059QF0KO0RSEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE SEROQUEL XR (QUETIAPINE FUMARATE) KIT [ASTRAZENECA PHARMACEUTICALS LP]30
QUETIAPINE FUMARATEACTIVE INGREDIENT2S3PL1B6UJSEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]10
QUETIAPINEACTIVE MOIETYBGL0JSY5SISEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]10
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]10
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]10
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]10
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]10
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQSEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]10
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRSEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]10
WATERINACTIVE INGREDIENT059QF0KO0RSEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0310-0283SEROQUEL XR (QUETIAPINE) TABLET, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]47Current NDC, Legacy NDC, 5 package rows20250313_473a3ac4-67f4-4782-baa9-7f9bdd8761f4.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 · 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
ndc (product): 0310-0283

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895670QUEtiapine fumarate 150 MG 24HR Extended Release Oral TabletPSN473a3ac4-67f4-4782-baa9-7f9bdd8761f447
721791QUEtiapine fumarate 200 MG 24HR Extended Release Oral TabletPSN473a3ac4-67f4-4782-baa9-7f9bdd8761f447
721794QUEtiapine fumarate 300 MG 24HR Extended Release Oral TabletPSN473a3ac4-67f4-4782-baa9-7f9bdd8761f447
721796QUEtiapine fumarate 400 MG 24HR Extended Release Oral TabletPSN473a3ac4-67f4-4782-baa9-7f9bdd8761f447
853201QUEtiapine fumarate 50 MG 24HR Extended Release Oral TabletPSN473a3ac4-67f4-4782-baa9-7f9bdd8761f447
895671SEROQUEL XR 150 MG 24HR Extended Release Oral TabletPSN473a3ac4-67f4-4782-baa9-7f9bdd8761f447
721793SEROQUEL XR 200 MG 24HR Extended Release Oral TabletPSN473a3ac4-67f4-4782-baa9-7f9bdd8761f447
721795SEROQUEL XR 300 MG 24HR Extended Release Oral TabletPSN473a3ac4-67f4-4782-baa9-7f9bdd8761f447
721797SEROQUEL XR 400 MG 24HR Extended Release Oral TabletPSN473a3ac4-67f4-4782-baa9-7f9bdd8761f447
853202SEROQUEL XR 50 MG 24HR Extended Release Oral TabletPSN473a3ac4-67f4-4782-baa9-7f9bdd8761f447
89567124 HR quetiapine 150 MG Extended Release Oral Tablet [Seroquel]SBD473a3ac4-67f4-4782-baa9-7f9bdd8761f447
72179324 HR quetiapine 200 MG Extended Release Oral Tablet [Seroquel]SBD473a3ac4-67f4-4782-baa9-7f9bdd8761f447
72179524 HR quetiapine 300 MG Extended Release Oral Tablet [Seroquel]SBD473a3ac4-67f4-4782-baa9-7f9bdd8761f447
72179724 HR quetiapine 400 MG Extended Release Oral Tablet [Seroquel]SBD473a3ac4-67f4-4782-baa9-7f9bdd8761f447
85320224 HR quetiapine 50 MG Extended Release Oral Tablet [Seroquel]SBD473a3ac4-67f4-4782-baa9-7f9bdd8761f447
89567024 HR quetiapine 150 MG Extended Release Oral TabletSCD473a3ac4-67f4-4782-baa9-7f9bdd8761f447
72179124 HR quetiapine 200 MG Extended Release Oral TabletSCD473a3ac4-67f4-4782-baa9-7f9bdd8761f447
72179424 HR quetiapine 300 MG Extended Release Oral TabletSCD473a3ac4-67f4-4782-baa9-7f9bdd8761f447
72179624 HR quetiapine 400 MG Extended Release Oral TabletSCD473a3ac4-67f4-4782-baa9-7f9bdd8761f447
85320124 HR quetiapine 50 MG Extended Release Oral TabletSCD473a3ac4-67f4-4782-baa9-7f9bdd8761f447
89567124 HR Seroquel 150 MG Extended Release Oral TabletSY473a3ac4-67f4-4782-baa9-7f9bdd8761f447
72179324 HR Seroquel 200 MG Extended Release Oral TabletSY473a3ac4-67f4-4782-baa9-7f9bdd8761f447
72179524 HR Seroquel 300 MG Extended Release Oral TabletSY473a3ac4-67f4-4782-baa9-7f9bdd8761f447
72179724 HR Seroquel 400 MG Extended Release Oral TabletSY473a3ac4-67f4-4782-baa9-7f9bdd8761f447
85320224 HR Seroquel 50 MG Extended Release Oral TabletSY473a3ac4-67f4-4782-baa9-7f9bdd8761f447
895670quetiapine 150 MG (as quetiapine fumarate 173 MG) 24 HR Extended Release Oral TabletSY473a3ac4-67f4-4782-baa9-7f9bdd8761f447
895670quetiapine 150 MG 24 HR Extended Release Oral TabletSY473a3ac4-67f4-4782-baa9-7f9bdd8761f447
721791quetiapine 200 MG (as quetiapine fumarate 230 MG) 24 HR Extended Release Oral TabletSY473a3ac4-67f4-4782-baa9-7f9bdd8761f447
721791quetiapine 200 MG 24 HR Extended Release Oral TabletSY473a3ac4-67f4-4782-baa9-7f9bdd8761f447
721794quetiapine 300 MG (as quetiapine fumarate 345 MG) 24 HR Extended Release Oral TabletSY473a3ac4-67f4-4782-baa9-7f9bdd8761f447
721794quetiapine 300 MG 24 HR Extended Release Oral TabletSY473a3ac4-67f4-4782-baa9-7f9bdd8761f447
721796quetiapine 400 MG (as quetiapine fumarate 461 MG) 24 HR Extended Release Oral TabletSY473a3ac4-67f4-4782-baa9-7f9bdd8761f447
853201quetiapine 50 MG (as quetiapine fumarate 58 MG) 24 HR Extended Release Oral TabletSY473a3ac4-67f4-4782-baa9-7f9bdd8761f447
853201quetiapine 50 MG 24 HR Extended Release Oral TabletSY473a3ac4-67f4-4782-baa9-7f9bdd8761f447
895671Seroquel XR 150 MG (quetiapine fumarate 173 MG) 24 HR Extended Release Oral TabletSY473a3ac4-67f4-4782-baa9-7f9bdd8761f447
721793Seroquel XR 200 MG (quetiapine fumarate 230 MG) 24 HR Extended Release Oral TabletSY473a3ac4-67f4-4782-baa9-7f9bdd8761f447
721795Seroquel XR 300 MG (quetiapine fumarate 345 MG) 24 HR Extended Release Oral TabletSY473a3ac4-67f4-4782-baa9-7f9bdd8761f447
721797Seroquel XR 400 MG (quetiapine fumarate 461 MG) 24 HR Extended Release Oral TabletSY473a3ac4-67f4-4782-baa9-7f9bdd8761f447
853202Seroquel XR 50 MG (quetiapine fumarate 58 MG) 24 HR Extended Release Oral TabletSY473a3ac4-67f4-4782-baa9-7f9bdd8761f447
895670QUEtiapine fumarate 150 MG 24HR Extended Release Oral TabletPSN51927f2e-3d56-4644-a6a8-40e0b9a5b57910
721791QUEtiapine fumarate 200 MG 24HR Extended Release Oral TabletPSN51927f2e-3d56-4644-a6a8-40e0b9a5b57910
721794QUEtiapine fumarate 300 MG 24HR Extended Release Oral TabletPSN51927f2e-3d56-4644-a6a8-40e0b9a5b57910
721796QUEtiapine fumarate 400 MG 24HR Extended Release Oral TabletPSN51927f2e-3d56-4644-a6a8-40e0b9a5b57910
853201QUEtiapine fumarate 50 MG 24HR Extended Release Oral TabletPSN51927f2e-3d56-4644-a6a8-40e0b9a5b57910
895671SEROQUEL XR 150 MG 24HR Extended Release Oral TabletPSN51927f2e-3d56-4644-a6a8-40e0b9a5b57910
721793SEROQUEL XR 200 MG 24HR Extended Release Oral TabletPSN51927f2e-3d56-4644-a6a8-40e0b9a5b57910
721795SEROQUEL XR 300 MG 24HR Extended Release Oral TabletPSN51927f2e-3d56-4644-a6a8-40e0b9a5b57910
721797SEROQUEL XR 400 MG 24HR Extended Release Oral TabletPSN51927f2e-3d56-4644-a6a8-40e0b9a5b57910
853202SEROQUEL XR 50 MG 24HR Extended Release Oral TabletPSN51927f2e-3d56-4644-a6a8-40e0b9a5b57910
89567124 HR quetiapine 150 MG Extended Release Oral Tablet [Seroquel]SBD51927f2e-3d56-4644-a6a8-40e0b9a5b57910
72179324 HR quetiapine 200 MG Extended Release Oral Tablet [Seroquel]SBD51927f2e-3d56-4644-a6a8-40e0b9a5b57910
72179524 HR quetiapine 300 MG Extended Release Oral Tablet [Seroquel]SBD51927f2e-3d56-4644-a6a8-40e0b9a5b57910
72179724 HR quetiapine 400 MG Extended Release Oral Tablet [Seroquel]SBD51927f2e-3d56-4644-a6a8-40e0b9a5b57910
85320224 HR quetiapine 50 MG Extended Release Oral Tablet [Seroquel]SBD51927f2e-3d56-4644-a6a8-40e0b9a5b57910
89567024 HR quetiapine 150 MG Extended Release Oral TabletSCD51927f2e-3d56-4644-a6a8-40e0b9a5b57910
72179124 HR quetiapine 200 MG Extended Release Oral TabletSCD51927f2e-3d56-4644-a6a8-40e0b9a5b57910
72179424 HR quetiapine 300 MG Extended Release Oral TabletSCD51927f2e-3d56-4644-a6a8-40e0b9a5b57910
72179624 HR quetiapine 400 MG Extended Release Oral TabletSCD51927f2e-3d56-4644-a6a8-40e0b9a5b57910
85320124 HR quetiapine 50 MG Extended Release Oral TabletSCD51927f2e-3d56-4644-a6a8-40e0b9a5b57910
89567124 HR Seroquel 150 MG Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
72179324 HR Seroquel 200 MG Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
72179524 HR Seroquel 300 MG Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
72179724 HR Seroquel 400 MG Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
85320224 HR Seroquel 50 MG Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
895670quetiapine 150 MG (as quetiapine fumarate 173 MG) 24 HR Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
895670quetiapine 150 MG 24 HR Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
721791quetiapine 200 MG (as quetiapine fumarate 230 MG) 24 HR Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
721791quetiapine 200 MG 24 HR Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
721794quetiapine 300 MG (as quetiapine fumarate 345 MG) 24 HR Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
721794quetiapine 300 MG 24 HR Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
721796quetiapine 400 MG (as quetiapine fumarate 461 MG) 24 HR Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
853201quetiapine 50 MG (as quetiapine fumarate 58 MG) 24 HR Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
853201quetiapine 50 MG 24 HR Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
895671Seroquel XR 150 MG (quetiapine fumarate 173 MG) 24 HR Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
721793Seroquel XR 200 MG (quetiapine fumarate 230 MG) 24 HR Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
721795Seroquel XR 300 MG (quetiapine fumarate 345 MG) 24 HR Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
721797Seroquel XR 400 MG (quetiapine fumarate 461 MG) 24 HR Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
853202Seroquel XR 50 MG (quetiapine fumarate 58 MG) 24 HR Extended Release Oral TabletSY51927f2e-3d56-4644-a6a8-40e0b9a5b57910
721794QUEtiapine fumarate 300 MG 24HR Extended Release Oral TabletPSN63cf6e35-4d68-4316-8579-823419f386de1
721795SEROQUEL XR 300 MG 24HR Extended Release Oral TabletPSN63cf6e35-4d68-4316-8579-823419f386de1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0310-0283-390031002833910 in 1 BLISTER PACKHistorical
0310-0283-5500310028355500 in 1 BOTTLEHistorical
0310-0283-600031002836060 TABLET, EXTENDED RELEASE in 1 BOTTLE (0310-0283-60) 2007-07-162027-01-31NoNoCurrent
0310-0283-94003100283944 in 1 BOTTLEHistorical