Quetiapine fumarate

Product NDC
63187-452
11-digit product format
631870452
Labeler code
63187
Product ID
63187-452_72502e4b-1ebb-4a61-aecf-f319be11ce9b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA202152
Marketing category
ANDA
Marketing start
2012-03-26
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 1.

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
A202152-001QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-27
A202152-002QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-27
A202152-003QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-27
A202152-004QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-27
A202152-005QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-27
A202152-006QUETIAPINE 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
A202152-001AB
A202152-002AB
A202152-003AB
A202152-004AB
A202152-005AB
A202152-006AB

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 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A202152-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202152-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202152-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202152-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202152-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202152-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202152-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202152-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202152-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202152-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202152-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202152-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A202152-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202152-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202152-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202152-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202152-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202152-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202152-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202152-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202152-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202152-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202152-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202152-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202152-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202152-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202152-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202152-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202152-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202152-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202152-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202152-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202152-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202152-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202152-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202152-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202152-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202152-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202152-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202152-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-272680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A202152-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202152-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202152-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202152-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202152-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202152-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202152-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202152-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202152-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202152-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202152-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202152-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202152-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202152-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202152-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202152-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202152-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202152-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202152-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202152-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202152-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202152-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202152-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202152-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202152-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202152-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202152-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202152-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202152-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202152-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202152-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202152-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202152-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202152-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202152-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202152-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202152-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202152-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202152-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202152-004AB12680178bc6a6…

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 · 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
1a147d6c-8af8-4379-8a13-1864a9a79b84Available 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
63187-452-03Quetiapine fumarate03 in 1 BOTTLETABLET, FILM COATED035
63187-452-30Quetiapine fumarate30 in 1 BOTTLETABLET, FILM COATED305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-452-03EA - Each63187-452a80a3f31-6941-4841-ab23-6d77c336949812017-06-15
63187-452-30EA - Each63187-452a89d2547-9ac4-4da7-b637-ea87f5353c7e12021-02-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
QUETIAPINE FUMARATEACTIVE INGREDIENT2S3PL1B6UJQUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]1
QUETIAPINEACTIVE MOIETYBGL0JSY5SIQUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPQUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UQUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTQUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XQUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AQUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EQUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPQUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-452QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]5Current NDC, Legacy NDC, 2 package rows20221021_1a147d6c-8af8-4379-8a13-1864a9a79b84.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QuetiapineQUETIAPINEBryant Ranch Prepackcb989abf-7d73-4ab9-a07f-a8c9de50389f2026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202152
application number: ANDA202152
QUETIAPINE FUMARATEQUETIAPINE FUMARATEBryant Ranch Prepacka45d8b77-f13d-41c5-8d50-15152fc6f85c2026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202152
application number: ANDA202152
QUETIAPINE FUMARATEQUETIAPINE FUMARATEBryant Ranch Prepack4e1e5249-1cb7-4cc2-ad5a-cdeeee2f494f2026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202152
application number: ANDA202152
QUETIAPINE FUMARATEQUETIAPINE FUMARATEBryant Ranch Prepack45c4c3a4-3acc-413e-9746-4816d513fac62026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202152
application number: ANDA202152
QuetiapineQUETIAPINEAccord Healthcare Inc.2d77412a-e084-4406-ac33-d882aece93542025-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202152
application number: ANDA202152
QuetiapineQUETIAPINEProficient Rx LP7a090720-fd90-4976-9aa2-41812106eb702022-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202152
application number: ANDA202152
Quetiapine fumarateQUETIAPINE FUMARATEProficient Rx LP1a147d6c-8af8-4379-8a13-1864a9a79b842022-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202152
application number: ANDA202152
ndc (product): 63187-452
Quetiapine fumarateQUETIAPINE FUMARATEProficient Rx LP8048ac0a-5d4d-4d00-ab9c-7fcac27f0a602022-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202152
application number: ANDA202152

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312744QUEtiapine fumarate 25 MG Oral TabletPSN1a147d6c-8af8-4379-8a13-1864a9a79b845
312744quetiapine 25 MG Oral TabletSCD1a147d6c-8af8-4379-8a13-1864a9a79b845
312744quetiapine (as quetiapine fumarate) 25 MG Oral TabletSY1a147d6c-8af8-4379-8a13-1864a9a79b845

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-452-03631870452033 TABLET, FILM COATED in 1 BOTTLE (63187-452-03) 2017-05-010000-00-00NoNoCurrent
63187-452-306318704523030 TABLET, FILM COATED in 1 BOTTLE (63187-452-30) 2017-05-010000-00-00NoNoCurrent