Quetiapine Fumarate

Product NDC
72189-446
Requested package NDC
72189-446-60
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 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
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 8 · 301 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A201504-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2013-02-1284e616aacf4f…
2026-09-14 22:38:342026-08A201504-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2013-02-1284e616aacf4f…
2026-09-14 22:38:342026-08A201504-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2013-02-1284e616aacf4f…
2026-09-14 22:38:342026-08A201504-004QUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2013-02-1284e616aacf4f…
2026-09-14 22:38:342026-08A201504-005QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2013-02-1284e616aacf4f…
2026-09-14 22:38:342026-08A201504-006QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2013-02-1284e616aacf4f…
2026-09-14 22:38:342026-08A201504-007QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2013-02-1284e616aacf4f…
2026-08-18 06:07:402026-07A201504-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2013-02-12caaa826d4ba7…
2026-08-18 06:07:402026-07A201504-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2013-02-12caaa826d4ba7…
2026-08-18 06:07:402026-07A201504-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2013-02-12caaa826d4ba7…
2026-08-18 06:07:402026-07A201504-004QUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2013-02-12caaa826d4ba7…
2026-08-18 06:07:402026-07A201504-005QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2013-02-12caaa826d4ba7…
2026-08-18 06:07:402026-07A201504-006QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2013-02-12caaa826d4ba7…
2026-08-18 06:07:402026-07A201504-007QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2013-02-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201504-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2013-02-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201504-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2013-02-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201504-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2013-02-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201504-004QUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2013-02-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201504-005QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2013-02-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201504-006QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2013-02-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201504-007QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2013-02-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201504-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2013-02-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201504-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2013-02-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201504-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2013-02-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201504-004QUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2013-02-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201504-005QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2013-02-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201504-006QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2013-02-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201504-007QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2013-02-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A201504-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2013-02-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201504-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2013-02-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201504-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2013-02-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201504-004QUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2013-02-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201504-005QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2013-02-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201504-006QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2013-02-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201504-007QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2013-02-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201504-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2013-02-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201504-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2013-02-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201504-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2013-02-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201504-004QUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2013-02-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201504-005QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2013-02-12fd3edfee7708…

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 22:38:342026-08A201504-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A201504-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A201504-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A201504-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A201504-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A201504-006AB184e616aacf4f…
2026-09-14 22:38:342026-08A201504-007AB184e616aacf4f…
2026-08-18 06:07:402026-07A201504-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A201504-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A201504-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A201504-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A201504-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A201504-006AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A201504-007AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201504-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201504-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201504-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201504-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201504-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201504-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201504-007AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201504-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201504-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201504-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201504-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201504-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201504-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201504-007AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201504-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201504-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201504-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201504-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201504-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201504-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201504-007AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201504-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201504-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201504-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201504-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201504-005AB1fd3edfee7708…

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
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

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 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quetiapine FumarateQUETIAPINE FUMARATEPreferred Pharmaceuticals Inc.717b55c4-a23f-4d74-8023-0f4e14d89ec82026-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201504
application number: ANDA201504
QuetiapineQUETIAPINEAscend Laboratories, LLC3112a006-1c61-47f2-84f5-9a7670d09c9b2026-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201504
application number: ANDA201504
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 (package): 72189-446-60
ndc (product): 72189-446
ndc11 (package): 72189044660
QuetiapineQUETIAPINECardinal Health 107, LLC32bc1ecb-7285-4013-b266-ca783a62d6172026-01-15Boxed 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
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
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
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
Quetiapine FumarateQUETIAPINE FUMARATEAdvanced Rx Pharmacy of Tennessee, LLCd2a76aed-a0b8-33f0-e053-2a95a90add0f2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201504
application number: ANDA201504
Quetiapine FumarateQUETIAPINE FUMARATEA-S Medication Solutions132a2483-7e49-4b0c-9db4-e6e578697fd92024-12-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201504
application number: ANDA201504
Quetiapine FumarateQUETIAPINE FUMARATEBryant Ranch Prepackd779f317-683b-4ec6-a309-1dd54332563f2024-08-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201504
application number: ANDA201504

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
72189-446-607218904466060 TABLET, FILM COATED in 1 BOTTLE (72189-446-60) 2023-03-14NoNoCurrent