Quetiapine fumarate

Product NDC
0904-6281
11-digit product format
009046281
Labeler code
0904
Product ID
0904-6281_2358a9bc-5466-42fd-b00e-2d70e4566d37
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA077380
Marketing category
ANDA
Marketing start
2012-04-02
Marketing end
0000-00-00
Substance
QUETIAPINE FUMARATE
Active strength
400 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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 productproduct0904-6281DDiscontinued by firm2026-10-05
excluded packagepackage0904-62810904-6281-61DDiscontinued by firm2026-10-05

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 packagepackage0904-6281-61d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0904-6281-61f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0904-6281-612ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0904-6281-61a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0904-6281-61cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0904-6281-61cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0904-6281-61302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0904-6281-61ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0904-6281-610efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0904-6281-61ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0904-6281-61367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0904-6281-61557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077380-001QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-27
A077380-002QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-27
A077380-003QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-27
A077380-004QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2012-03-27
A077380-005QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-27
A077380-006QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-27
A077380-007QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 7 matching rows.

Application-product, TE code table
Application-productTE code
A077380-001AB
A077380-002AB
A077380-003AB
A077380-004AB
A077380-005AB
A077380-006AB
A077380-007AB

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 · 301 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077380-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A077380-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A077380-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A077380-004QUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2012-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A077380-005QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A077380-006QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A077380-007QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-2784e616aacf4f…
2026-08-18 06:07:402026-07A077380-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A077380-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A077380-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A077380-004QUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2012-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A077380-005QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A077380-006QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A077380-007QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077380-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077380-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077380-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077380-004QUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077380-005QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077380-006QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077380-007QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077380-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077380-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077380-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077380-004QUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077380-005QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077380-006QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077380-007QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A077380-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077380-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077380-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077380-004QUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077380-005QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077380-006QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077380-007QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077380-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077380-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077380-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077380-004QUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077380-005QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-27fd3edfee7708…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 301 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A077380-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A077380-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A077380-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A077380-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A077380-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A077380-006AB184e616aacf4f…
2026-09-14 22:38:342026-08A077380-007AB184e616aacf4f…
2026-08-18 06:07:402026-07A077380-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077380-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077380-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077380-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077380-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077380-006AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077380-007AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077380-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077380-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077380-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077380-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077380-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077380-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077380-007AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077380-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077380-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077380-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077380-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077380-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077380-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077380-007AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077380-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077380-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077380-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077380-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077380-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077380-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077380-007AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077380-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077380-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077380-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077380-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077380-005AB1fd3edfee7708…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6281-61EA - Each0904-62816015021d-c376-4a2b-9f72-c49f6fff178512013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
QUETIAPINE FUMARATEACTIVE INGREDIENT2S3PL1B6UJQUETIAPINE FUMARATE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]3
QUETIAPINEACTIVE MOIETYBGL0JSY5SIQUETIAPINE FUMARATE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]3
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPQUETIAPINE FUMARATE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UQUETIAPINE FUMARATE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTQUETIAPINE FUMARATE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]3
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4QUETIAPINE FUMARATE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XQUETIAPINE FUMARATE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30QUETIAPINE FUMARATE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQQUETIAPINE FUMARATE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]3
POVIDONEINACTIVE INGREDIENTFZ989GH94EQUETIAPINE FUMARATE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4QUETIAPINE FUMARATE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2QUETIAPINE FUMARATE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPQUETIAPINE FUMARATE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]3