Quetiapine Fumarate

Product NDC
46708-134
Requested package NDC
46708-134-31
11-digit product format
467080134
Labeler code
46708
Product ID
46708-134_1b3c037f-0cff-49a4-9ef2-5e19fdd21bc6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
quetiapine fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA203390
Marketing category
ANDA
Marketing start
2017-02-21
Substance
QUETIAPINE FUMARATE
Active strength
25 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A203390-001QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 25MG BASETABLET / ORAL2014-10-28
A203390-002QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 50MG BASETABLET / ORAL2014-10-28
A203390-003QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 100MG BASETABLET / ORAL2014-10-28
A203390-004QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 200MG BASETABLET / ORAL2014-10-28
A203390-005QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 300MG BASETABLET / ORAL2014-10-28
A203390-006QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 400MG BASETABLET / ORAL2014-10-28

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 22:38:342026-08A203390-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORAL2014-10-2884e616aacf4f…
2026-09-14 22:38:342026-08A203390-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORAL2014-10-2884e616aacf4f…
2026-09-14 22:38:342026-08A203390-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORAL2014-10-2884e616aacf4f…
2026-09-14 22:38:342026-08A203390-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORAL2014-10-2884e616aacf4f…
2026-09-14 22:38:342026-08A203390-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORAL2014-10-2884e616aacf4f…
2026-09-14 22:38:342026-08A203390-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORAL2014-10-2884e616aacf4f…
2026-08-18 06:07:402026-07A203390-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORAL2014-10-28caaa826d4ba7…
2026-08-18 06:07:402026-07A203390-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORAL2014-10-28caaa826d4ba7…
2026-08-18 06:07:402026-07A203390-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORAL2014-10-28caaa826d4ba7…
2026-08-18 06:07:402026-07A203390-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORAL2014-10-28caaa826d4ba7…
2026-08-18 06:07:402026-07A203390-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORAL2014-10-28caaa826d4ba7…
2026-08-18 06:07:402026-07A203390-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORAL2014-10-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203390-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORAL2014-10-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203390-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORAL2014-10-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203390-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORAL2014-10-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203390-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORAL2014-10-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203390-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORAL2014-10-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203390-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORAL2014-10-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203390-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORAL2014-10-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203390-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORAL2014-10-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203390-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORAL2014-10-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203390-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORAL2014-10-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203390-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORAL2014-10-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203390-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORAL2014-10-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A203390-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORAL2014-10-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203390-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORAL2014-10-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203390-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORAL2014-10-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203390-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORAL2014-10-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203390-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORAL2014-10-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203390-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORAL2014-10-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203390-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORAL2014-10-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203390-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORAL2014-10-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203390-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORAL2014-10-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203390-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORAL2014-10-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203390-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORAL2014-10-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203390-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORAL2014-10-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203390-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORAL2014-10-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203390-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORAL2014-10-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203390-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORAL2014-10-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203390-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORAL2014-10-28b8a1b40f171c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A203390-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203390-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203390-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203390-004AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203390-005AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203390-006AB174a2ff9319b5…
2020-11-12 02:37 UTC2020-11A203390-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A203390-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A203390-003AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A203390-004AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A203390-005AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A203390-006AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203390-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A203390-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A203390-003AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A203390-004AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A203390-005AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A203390-006AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A203390-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A203390-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A203390-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A203390-004AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A203390-005AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A203390-006AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A203390-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A203390-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A203390-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A203390-004AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A203390-005AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A203390-006AB1ea99ee380514…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
QUETIAPINE FUMARATE25 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 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312743Internal RxNorm lookup
312744Internal RxNorm lookup
312745Internal RxNorm lookup
317174Internal RxNorm lookup
616483Internal RxNorm lookup
616487Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
93ab6237-321e-4a2c-b0ca-3fc9acb31f9aAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
46708-134-102023-02-01These highlights do not include all the information needed to use QUETIAPINE FUMARATE TABLETS safely and effectively. See full prescribing information for QUETIAPINE FUMARATE TABLETS. QUETIAPINE FUMARATE tablets, for oral use Initial U.S. Approval: 1997
46708-134-302023-02-01These highlights do not include all the information needed to use QUETIAPINE FUMARATE TABLETS safely and effectively. See full prescribing information for QUETIAPINE FUMARATE TABLETS. QUETIAPINE FUMARATE tablets, for oral use Initial U.S. Approval: 1997
46708-134-312023-02-01These highlights do not include all the information needed to use QUETIAPINE FUMARATE TABLETS safely and effectively. See full prescribing information for QUETIAPINE FUMARATE TABLETS. QUETIAPINE FUMARATE tablets, for oral use Initial U.S. Approval: 1997
46708-134-912023-02-01These highlights do not include all the information needed to use QUETIAPINE FUMARATE TABLETS safely and effectively. See full prescribing information for QUETIAPINE FUMARATE TABLETS. QUETIAPINE FUMARATE tablets, for oral use Initial U.S. Approval: 1997
46708-134-102023-01-30These highlights do not include all the information needed to use QUETIAPINE FUMARATE TABLETS safely and effectively. See full prescribing information for QUETIAPINE FUMARATE TABLETS. QUETIAPINE FUMARATE tablets, for oral use Initial U.S. Approval: 1997
46708-134-302023-01-30These highlights do not include all the information needed to use QUETIAPINE FUMARATE TABLETS safely and effectively. See full prescribing information for QUETIAPINE FUMARATE TABLETS. QUETIAPINE FUMARATE tablets, for oral use Initial U.S. Approval: 1997
46708-134-312023-01-30These highlights do not include all the information needed to use QUETIAPINE FUMARATE TABLETS safely and effectively. See full prescribing information for QUETIAPINE FUMARATE TABLETS. QUETIAPINE FUMARATE tablets, for oral use Initial U.S. Approval: 1997
46708-134-912023-01-30These highlights do not include all the information needed to use QUETIAPINE FUMARATE TABLETS safely and effectively. See full prescribing information for QUETIAPINE FUMARATE TABLETS. QUETIAPINE FUMARATE tablets, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-134-10Quetiapine Fumarate100 in 1 CARTONTABLET, FILM COATED1007
46708-134-30Quetiapine Fumarate30 in 1 BOTTLETABLET, FILM COATED307
46708-134-31Quetiapine Fumarate100 in 1 BOTTLETABLET, FILM COATED1007
46708-134-91Quetiapine Fumarate1000 in 1 BOTTLETABLET, FILM COATED10007

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-134QUETIAPINE FUMARATE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]7Current NDC, Legacy NDC, 4 package rows20230202_93ab6237-321e-4a2c-b0ca-3fc9acb31f9a.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quetiapine FumarateQUETIAPINE FUMARATEAlembic Pharmaceuticals Limited93ab6237-321e-4a2c-b0ca-3fc9acb31f9a2023-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203390
application number: ANDA203390
ndc (package): 46708-134-31
ndc (product): 46708-134
ndc11 (package): 46708013431

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312743QUEtiapine fumarate 100 MG Oral TabletPSN93ab6237-321e-4a2c-b0ca-3fc9acb31f9a7
317174QUEtiapine fumarate 200 MG Oral TabletPSN93ab6237-321e-4a2c-b0ca-3fc9acb31f9a7
312744QUEtiapine fumarate 25 MG Oral TabletPSN93ab6237-321e-4a2c-b0ca-3fc9acb31f9a7
312745QUEtiapine fumarate 300 MG Oral TabletPSN93ab6237-321e-4a2c-b0ca-3fc9acb31f9a7
616483QUEtiapine fumarate 400 MG Oral TabletPSN93ab6237-321e-4a2c-b0ca-3fc9acb31f9a7
616487QUEtiapine fumarate 50 MG Oral TabletPSN93ab6237-321e-4a2c-b0ca-3fc9acb31f9a7
312743quetiapine 100 MG Oral TabletSCD93ab6237-321e-4a2c-b0ca-3fc9acb31f9a7
317174quetiapine 200 MG Oral TabletSCD93ab6237-321e-4a2c-b0ca-3fc9acb31f9a7
312744quetiapine 25 MG Oral TabletSCD93ab6237-321e-4a2c-b0ca-3fc9acb31f9a7
312745quetiapine 300 MG Oral TabletSCD93ab6237-321e-4a2c-b0ca-3fc9acb31f9a7
616483quetiapine 400 MG Oral TabletSCD93ab6237-321e-4a2c-b0ca-3fc9acb31f9a7
616487quetiapine 50 MG Oral TabletSCD93ab6237-321e-4a2c-b0ca-3fc9acb31f9a7
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY93ab6237-321e-4a2c-b0ca-3fc9acb31f9a7
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSY93ab6237-321e-4a2c-b0ca-3fc9acb31f9a7
312744quetiapine (as quetiapine fumarate) 25 MG Oral TabletSY93ab6237-321e-4a2c-b0ca-3fc9acb31f9a7
312745quetiapine (as quetiapine fumarate) 300 MG Oral TabletSY93ab6237-321e-4a2c-b0ca-3fc9acb31f9a7
616483quetiapine (as quetiapine fumarate) 400 MG Oral TabletSY93ab6237-321e-4a2c-b0ca-3fc9acb31f9a7
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSY93ab6237-321e-4a2c-b0ca-3fc9acb31f9a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46708-134-3146708013431100 TABLET, FILM COATED in 1 BOTTLE (46708-134-31) 2017-02-210000-00-00NoNoCurrent