quetiapine fumarate

Product NDC
60505-3135
Requested package NDC
60505-3135-8
11-digit product format
605053135
Labeler code
60505
Product ID
60505-3135_bdf36658-c472-9290-51e8-289072ae3157
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
quetiapine fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA090960
Marketing category
ANDA
Marketing start
2012-03-27
Marketing end
2021-06-30
Substance
QUETIAPINE FUMARATE
Active strength
200 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage60505-313560505-3135-8DDiscontinued 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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090960-001QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-27
A090960-002QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-27
A090960-003QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-27
A090960-004QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-27
A090960-005QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-27
A090960-006QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090960-001AB
A090960-002AB
A090960-003AB
A090960-004AB
A090960-005AB
A090960-006AB

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 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090960-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A090960-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A090960-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A090960-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A090960-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A090960-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-2784e616aacf4f…
2026-08-18 06:07:402026-07A090960-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A090960-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A090960-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A090960-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A090960-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A090960-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090960-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090960-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090960-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090960-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090960-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090960-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090960-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090960-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090960-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090960-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090960-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090960-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A090960-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090960-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090960-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090960-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090960-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090960-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090960-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090960-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090960-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090960-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090960-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090960-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090960-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090960-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090960-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090960-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A090960-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A090960-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A090960-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A090960-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A090960-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A090960-006AB184e616aacf4f…
2026-08-18 06:07:402026-07A090960-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090960-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090960-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090960-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090960-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090960-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090960-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090960-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090960-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090960-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090960-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090960-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090960-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090960-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090960-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090960-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090960-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090960-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090960-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090960-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090960-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090960-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090960-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090960-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090960-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090960-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090960-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090960-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090960-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090960-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090960-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090960-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090960-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090960-004AB1b8a1b40f171c…

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
60505-3135-1EA - Each60505-31350ad89ef6-f67e-4852-a5af-beccbb7c290312012-07-24
60505-3135-8EA - Each60505-3135cc6f48d2-6f11-4fa0-a8dc-b8ed1f5b1d8512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
QUETIAPINE FUMARATEACTIVE INGREDIENT2S3PL1B6UJQUETIAPINE FUMARATE TABLET, FILM COATED [APOTEX CORP.]5
QUETIAPINEACTIVE MOIETYBGL0JSY5SIQUETIAPINE FUMARATE TABLET, FILM COATED [APOTEX CORP.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48QUETIAPINE FUMARATE TABLET, FILM COATED [APOTEX CORP.]5
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BQUETIAPINE FUMARATE TABLET, FILM COATED [APOTEX CORP.]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675QUETIAPINE FUMARATE TABLET, FILM COATED [APOTEX CORP.]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTQUETIAPINE FUMARATE TABLET, FILM COATED [APOTEX CORP.]5
FUMARIC ACIDINACTIVE INGREDIENT88XHZ13131QUETIAPINE FUMARATE TABLET, FILM COATED [APOTEX CORP.]5
Hydroxypropyl Cellulose (Type L)INACTIVE INGREDIENTUKE75GEA7FQUETIAPINE FUMARATE TABLET, FILM COATED [APOTEX CORP.]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOQUETIAPINE FUMARATE TABLET, FILM COATED [APOTEX CORP.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30QUETIAPINE FUMARATE TABLET, FILM COATED [APOTEX CORP.]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AQUETIAPINE FUMARATE TABLET, FILM COATED [APOTEX CORP.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4QUETIAPINE FUMARATE TABLET, FILM COATED [APOTEX CORP.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPQUETIAPINE FUMARATE TABLET, FILM COATED [APOTEX CORP.]5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-3135-8605053135081000 TABLET, FILM COATED in 1 BOTTLE (60505-3135-8) 2012-03-272021-06-30NoNoCurrent