Quetiapine Fumarate

Product NDC
72189-446
11-digit product format
721890446
Labeler code
72189
Product ID
72189-446_4c4b8f97-e2a3-7bdf-e063-6294a90af5cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine Fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA201504
Marketing category
ANDA
Marketing start
2023-03-14
Substance
QUETIAPINE FUMARATE
Active strength
25 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A201504-001QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2013-02-12
A201504-002QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2013-02-12
A201504-003QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2013-02-12
A201504-004QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2013-02-12
A201504-005QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2013-02-12
A201504-006QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2013-02-12
A201504-007QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2013-02-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A201504-001AB
A201504-002AB
A201504-003AB
A201504-004AB
A201504-005AB
A201504-006AB
A201504-007AB

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 6 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201504-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2013-02-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201504-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2013-02-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201504-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2013-02-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201504-004QUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2013-02-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201504-005QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2013-02-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201504-006QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2013-02-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201504-007QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2013-02-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201504-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2013-02-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201504-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2013-02-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201504-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2013-02-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201504-004QUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2013-02-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201504-005QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2013-02-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201504-006QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2013-02-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201504-007QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2013-02-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201504-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2013-02-128072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201504-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2013-02-128072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201504-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2013-02-128072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201504-004QUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2013-02-128072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201504-005QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2013-02-128072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201504-006QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2013-02-128072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201504-007QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2013-02-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201504-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2013-02-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201504-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2013-02-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201504-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2013-02-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201504-004QUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2013-02-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201504-005QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2013-02-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201504-006QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2013-02-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201504-007QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2013-02-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201504-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2013-02-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201504-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2013-02-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201504-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2013-02-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201504-004QUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2013-02-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201504-005QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2013-02-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201504-006QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2013-02-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201504-007QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2013-02-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201504-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2013-02-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A201504-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2013-02-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A201504-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2013-02-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A201504-004QUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2013-02-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A201504-005QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2013-02-124b0b4de00fa7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201504-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201504-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201504-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201504-004AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201504-005AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201504-006AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201504-007AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201504-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201504-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201504-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201504-004AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201504-005AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201504-006AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201504-007AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201504-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201504-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201504-003AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201504-004AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201504-005AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201504-006AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201504-007AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201504-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201504-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201504-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201504-004AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201504-005AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201504-006AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201504-007AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201504-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201504-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201504-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201504-004AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201504-005AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201504-006AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201504-007AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201504-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A201504-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A201504-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A201504-004AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A201504-005AB14b0b4de00fa7…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 29 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QuetiapineQUETIAPINECoupler LLC56052e5c-0b0b-c296-e063-6394a90a5ad62026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201504
application number: ANDA201504
Quetiapine FumarateQUETIAPINE FUMARATENuCare Pharmaceuticals,Inc.16f48034-b8c9-ab2b-e063-6294a90adf652026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201504
application number: ANDA201504
Quetiapine FumarateQUETIAPINE FUMARATEDirect_Rxf6de1d2b-b10e-2e9a-e053-6394a90a735d2026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201504
application number: ANDA201504
ndc (product): 72189-446
QuetiapineQUETIAPINECardinal Health 107, LLC32bc1ecb-7285-4013-b266-ca783a62d6172026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201504
application number: ANDA201504
QuetiapineQUETIAPINEMajor Pharmaceuticalsf9447739-9e21-4232-950f-174c0496ab662026-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201504
application number: ANDA201504
Quetiapine FumarateQUETIAPINEA-S Medication Solutions10288afa-c4dc-4897-9ec8-f4573d8507792025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201504
application number: ANDA201504
Quetiapine FumarateQUETIAPINE FUMARATEAvPAK6b7d7d2f-a50b-8e21-2de4-ccc1020163842025-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201504
application number: ANDA201504
QuetiapineQUETIAPINEASCLEMED USA INC.74e09734-26cb-42fe-b9a3-79cc10505e0b2025-10-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201504
application number: ANDA201504
Quetiapine FumarateQUETIAPINE FUMARATEPreferred Pharmaceuticals Inc.717b55c4-a23f-4d74-8023-0f4e14d89ec82025-09-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201504
application number: ANDA201504
QuetiapineQUETIAPINEREMEDYREPACK INC.b7aa0fce-1406-4665-a791-e30aed7b24ff2025-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201504
application number: ANDA201504
QuetiapineQUETIAPINEBryant Ranch Prepack01261008-5f42-4844-8a65-d4545a67a3092025-06-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201504
application number: ANDA201504
Quetiapine FumarateQUETIAPINE FUMARATEBryant Ranch Prepackf75a4d38-ea0e-4780-abf2-67672894a11b2025-06-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201504
application number: ANDA201504
Quetiapine FumarateQUETIAPINE FUMARATEDirect_Rxe4ce9d50-9786-2233-e053-2a95a90a276f2025-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201504
application number: ANDA201504
QuetiapineQUETIAPINEAscend Laboratories, LLC3112a006-1c61-47f2-84f5-9a7670d09c9b2025-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201504
application number: ANDA201504
Quetiapine FumarateQUETIAPINE FUMARATEBryant Ranch Prepack6efc2886-7dcc-4dac-a212-76078a7efaa72025-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201504
application number: ANDA201504
Quetiapine FumarateQUETIAPINE FUMARATEBryant Ranch Prepack45947f72-d870-4f6e-9e5f-38d6b324d5fe2025-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201504
application number: ANDA201504
Quetiapine FumarateQUETIAPINE FUMARATEBryant Ranch Prepack35b2069e-209a-41ac-84e6-377d4f19be872025-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201504
application number: ANDA201504
QuetiapineQUETIAPINEPD-Rx Pharmaceuticals, Inc.da3c9642-9f8d-422b-8e12-2036d68f78ca2025-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201504
application number: ANDA201504
Quetiapine FumarateQUETIAPINE FUMARATEPreferred Pharmaceuticals Inc.69275af7-1469-4405-a98e-e8b0f8d42dd92025-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201504
application number: ANDA201504
Quetiapine FumarateQUETIAPINE FUMARATEDirect Rxdb48ec02-1119-f343-e053-2a95a90afb3b2025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201504
application number: ANDA201504

Additional Listing Data#

Finished product
Yes
Brand name base
Quetiapine Fumarate
Listing expiration
2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312744Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f6de1d2b-b10e-2e9a-e053-6394a90a735dAvailable 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
72189-446-30Quetiapine Fumarate30 in 1 BOTTLETABLET, FILM COATED303
72189-446-60Quetiapine Fumarate60 in 1 BOTTLETABLET, FILM COATED603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-446-30EA - Each72189-446a8fd7980-aff0-4a8d-8b0e-40cf8052a19612023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-446QUETIAPINE FUMARATE TABLET [DIRECT_RX]2Current NDC, 2 package rows20250123_f6de1d2b-b10e-2e9a-e053-6394a90a735d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312744QUEtiapine fumarate 25 MG Oral TabletPSNf6de1d2b-b10e-2e9a-e053-6394a90a735d3
312744quetiapine 25 MG Oral TabletSCDf6de1d2b-b10e-2e9a-e053-6394a90a735d3
312744quetiapine (as quetiapine fumarate) 25 MG Oral TabletSYf6de1d2b-b10e-2e9a-e053-6394a90a735d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72189-446-307218904463030 TABLET, FILM COATED in 1 BOTTLE (72189-446-30) 2023-03-14NoNoCurrent
72189-446-607218904466060 TABLET, FILM COATED in 1 BOTTLE (72189-446-60) 2023-03-14NoNoCurrent