Quetiapine fumarate

Product NDC
71335-2462
11-digit product format
713352462
Labeler code
71335
Product ID
71335-2462_d98d1381-2bb8-4dd6-a247-635ec2d2651b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
quetiapine fumarate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA201109
Marketing category
ANDA
Marketing start
2012-03-27
Substance
QUETIAPINE FUMARATE
Active strength
400 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
A201109-001QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-27
A201109-002QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-27
A201109-003QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-27
A201109-004QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-27
A201109-005QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-27
A201109-006QUETIAPINE 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
A201109-001AB
A201109-002AB
A201109-003AB
A201109-004AB
A201109-005AB
A201109-006AB

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 22:38:342026-08A201109-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A201109-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A201109-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A201109-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A201109-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A201109-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-2784e616aacf4f…
2026-08-18 06:07:402026-07A201109-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A201109-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A201109-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A201109-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A201109-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A201109-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201109-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201109-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201109-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201109-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201109-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201109-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201109-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201109-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201109-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201109-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201109-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201109-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A201109-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201109-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201109-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201109-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201109-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201109-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201109-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201109-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201109-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201109-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201109-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201109-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201109-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201109-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201109-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201109-004QUETIAPINE 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 22:38:342026-08A201109-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A201109-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A201109-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A201109-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A201109-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A201109-006AB184e616aacf4f…
2026-08-18 06:07:402026-07A201109-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A201109-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A201109-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A201109-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A201109-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A201109-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201109-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201109-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201109-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201109-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201109-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201109-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201109-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201109-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201109-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201109-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201109-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201109-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201109-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201109-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201109-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201109-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201109-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201109-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201109-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201109-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201109-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201109-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201109-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201109-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201109-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201109-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201109-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201109-004AB1b8a1b40f171c…

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 FUMARATE400 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
616483Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
35f6ad40-192a-4d1f-ace0-9fb69b9d984dAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2462-1Quetiapine fumarate30 in 1 BOTTLETABLET302
71335-2462-2Quetiapine fumarate28 in 1 BOTTLETABLET282
71335-2462-3Quetiapine fumarate60 in 1 BOTTLETABLET602
71335-2462-4Quetiapine fumarate180 in 1 BOTTLETABLET1802
71335-2462-5Quetiapine fumarate90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2462QUETIAPINE FUMARATE TABLET [BRYANT RANCH PREPACK]2Current NDC, 5 package rows20250303_35f6ad40-192a-4d1f-ace0-9fb69b9d984d.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 2 · 30 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quetiapine fumarateQUETIAPINE FUMARATEPreferred Pharmaceuticals Inc.711f42c5-0719-46de-81fb-3d03801b9ed92026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201109
application number: ANDA201109
Quetiapine fumarateQUETIAPINE FUMARATENuCare Pharmaceuticals,Inc.227b8b2b-a238-efb4-e063-6394a90acc7e2026-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201109
application number: ANDA201109
Quetiapine fumarateQUETIAPINE FUMARATEREMEDYREPACK INC.c6c454c4-3eae-48ae-bf17-5dccdb6591412026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201109
application number: ANDA201109
Quetiapine fumarateQUETIAPINE FUMARATEREMEDYREPACK INC.d38f0f4e-dc0f-4c92-a212-c4da3db748012026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201109
application number: ANDA201109
Quetiapine fumarateQUETIAPINE FUMARATEREMEDYREPACK INC.ea9b9ed1-4be0-4dc0-b1dd-239caff5253e2026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201109
application number: ANDA201109
Quetiapine fumarateQUETIAPINE FUMARATEREMEDYREPACK INC.02b19885-2987-4c46-8d2a-5e59656f72e82026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201109
application number: ANDA201109
Quetiapine fumarateQUETIAPINE FUMARATEREMEDYREPACK INC.695415b1-083d-4540-9f41-bde4b201f8342026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201109
application number: ANDA201109
Quetiapine fumarateQUETIAPINE FUMARATEBryant Ranch Prepack94a81681-381e-4b3b-89ac-e86dcbe7f8902026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201109
application number: ANDA201109
Quetiapine fumarateQUETIAPINE FUMARATEBryant Ranch Prepackfd9cce28-0052-4b0b-8a66-a1615e082d952026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201109
application number: ANDA201109
Quetiapine fumarateQUETIAPINECoupler LLC5643d339-50ea-405d-e063-6394a90a3b702026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201109
application number: ANDA201109
Quetiapine fumarateQUETIAPINEUnit Dose Solutions, Inc.55f358e1-9458-b197-e063-6394a90a3f0e2026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201109
application number: ANDA201109
Quetiapine fumarateQUETIAPINE FUMARATEUnit Dose Solutions, Inc.55f574bc-ec55-93e2-e063-6394a90a1d472026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201109
application number: ANDA201109
Quetiapine fumarateQUETIAPINEUnit Dose Solutions, Inc.559fdce5-ab3e-0d02-e063-6394a90a7fbd2026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201109
application number: ANDA201109
Quetiapine fumarateQUETIAPINEUnit Dose Solutions, Inc.55a5671b-7771-0adf-e063-6294a90acfa62026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201109
application number: ANDA201109
Quetiapine fumarateQUETIAPINE FUMARATESt. Mary's Medical Park Pharmacy36248b77-277c-7d66-e063-6394a90ae1e82026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201109
application number: ANDA201109
Quetiapine fumarateQUETIAPINECoupler LLC544f6e91-e61f-c57a-e063-6294a90af9d12026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201109
application number: ANDA201109
Quetiapine fumarateQUETIAPINE FUMARATESt. Mary's Medical Park Pharmacy3624100f-6e3f-a2ad-e063-6294a90a0fc02026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201109
application number: ANDA201109
Quetiapine fumarateQUETIAPINE FUMARATELupin Pharmaceuticals, Inc.a951cd63-d329-47c9-965a-582fa73a07c62026-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201109
application number: ANDA201109
Quetiapine fumarateQUETIAPINECoupler LLC533154bb-a596-c88b-e063-6294a90a89562026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201109
application number: ANDA201109
Quetiapine fumarateQUETIAPINECoupler LLC52ba669d-c846-03c2-e063-6394a90ac0f02026-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201109
application number: ANDA201109

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616483QUEtiapine fumarate 400 MG Oral TabletPSN35f6ad40-192a-4d1f-ace0-9fb69b9d984d2
616483quetiapine 400 MG Oral TabletSCD35f6ad40-192a-4d1f-ace0-9fb69b9d984d2
616483quetiapine (as quetiapine fumarate) 400 MG Oral TabletSY35f6ad40-192a-4d1f-ace0-9fb69b9d984d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2462-17133524620130 TABLET in 1 BOTTLE (71335-2462-1) 30 tablet2024-10-01NoNoCurrent
71335-2462-27133524620228 TABLET in 1 BOTTLE (71335-2462-2) 28 tablet2025-02-03NoNoCurrent
71335-2462-37133524620360 TABLET in 1 BOTTLE (71335-2462-3) 60 tablet2024-12-13NoNoCurrent
71335-2462-471335246204180 TABLET in 1 BOTTLE (71335-2462-4) 180 tablet2025-02-03NoNoCurrent
71335-2462-57133524620590 TABLET in 1 BOTTLE (71335-2462-5) 90 tablet2024-08-01NoNoCurrent