QUETIAPINE

Product NDC
33342-134
11-digit product format
333420134
Labeler code
33342
Product ID
33342-134_fb91b782-1195-4212-b130-9e078dc47dcd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
QUETIAPINE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA204253
Marketing category
ANDA
Marketing start
2017-11-01
Substance
QUETIAPINE FUMARATE
Active strength
150 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204253-001QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29
A204253-002QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29
A204253-003QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29
A204253-004QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A204253-001AB
A204253-002AB
A204253-003AB
A204253-004AB

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 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A204253-001QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204253-002QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204253-003QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204253-004QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204253-001QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204253-002QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204253-003QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204253-004QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A204253-001QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204253-002QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204253-003QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204253-004QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204253-001QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204253-002QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204253-003QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204253-004QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204253-001QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204253-002QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204253-003QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204253-004QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204253-001QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204253-002QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204253-003QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204253-004QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204253-001QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204253-002QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204253-003QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204253-004QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204253-001QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204253-002QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204253-003QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204253-004QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204253-001QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204253-002QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204253-003QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204253-004QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204253-001QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A204253-002QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A204253-003QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A204253-004QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A204253-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204253-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204253-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204253-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204253-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204253-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204253-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204253-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204253-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204253-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204253-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204253-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204253-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204253-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204253-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204253-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204253-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204253-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204253-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204253-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204253-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204253-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204253-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204253-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204253-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204253-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204253-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204253-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204253-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204253-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204253-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204253-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204253-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204253-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204253-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204253-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204253-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204253-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204253-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204253-004AB1d06236e962d9…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
QUETIAPINE FUMARATE150 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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
721791Internal RxNorm lookup
721794Internal RxNorm lookup
721796Internal RxNorm lookup
895670Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d699b8c7-8a1c-44ed-85d8-c821a9c8c848Available 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
33342-134-09QUETIAPINE60 in 1 BOTTLETABLET, EXTENDED RELEASE608
33342-134-15QUETIAPINE500 in 1 BOTTLETABLET, EXTENDED RELEASE5008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-134-09EA - Each33342-134546cf99a-a803-47a0-9998-d353098d4c9012018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-134QUETIAPINE TABLET, EXTENDED RELEASE [MACLEODS PHARMACEUTICALS LIMITED]8Current NDC, Legacy NDC, 2 package rows20230801_d699b8c7-8a1c-44ed-85d8-c821a9c8c848.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QUETIAPINEQUETIAPINEREMEDYREPACK INC.90da6c48-3282-41dc-b4fa-75d33efa9fee2026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204253
application number: ANDA204253
QUETIAPINEQUETIAPINEREMEDYREPACK INC.67872105-4ec6-4d46-b3b4-c672c93576d22026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204253
application number: ANDA204253
Quetiapine Fumarate ERQUETIAPINE FUMARATE ERDirect_Rx3fb5c81f-ce5f-98bf-e063-6294a90a57112025-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204253
application number: ANDA204253
QUETIAPINEQUETIAPINEBryant Ranch Prepackb78b4e12-8ec4-470d-9bb5-665b5af328f52025-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204253
application number: ANDA204253
QUETIAPINEQUETIAPINEMacleods Pharmaceuticals Limitedd699b8c7-8a1c-44ed-85d8-c821a9c8c8482023-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204253
application number: ANDA204253
ndc (product): 33342-134

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895670QUEtiapine fumarate 150 MG 24HR Extended Release Oral TabletPSNd699b8c7-8a1c-44ed-85d8-c821a9c8c8488
721791QUEtiapine fumarate 200 MG 24HR Extended Release Oral TabletPSNd699b8c7-8a1c-44ed-85d8-c821a9c8c8488
721794QUEtiapine fumarate 300 MG 24HR Extended Release Oral TabletPSNd699b8c7-8a1c-44ed-85d8-c821a9c8c8488
721796QUEtiapine fumarate 400 MG 24HR Extended Release Oral TabletPSNd699b8c7-8a1c-44ed-85d8-c821a9c8c8488
89567024 HR quetiapine 150 MG Extended Release Oral TabletSCDd699b8c7-8a1c-44ed-85d8-c821a9c8c8488
72179124 HR quetiapine 200 MG Extended Release Oral TabletSCDd699b8c7-8a1c-44ed-85d8-c821a9c8c8488
72179424 HR quetiapine 300 MG Extended Release Oral TabletSCDd699b8c7-8a1c-44ed-85d8-c821a9c8c8488
72179624 HR quetiapine 400 MG Extended Release Oral TabletSCDd699b8c7-8a1c-44ed-85d8-c821a9c8c8488
895670quetiapine 150 MG (as quetiapine fumarate 173 MG) 24 HR Extended Release Oral TabletSYd699b8c7-8a1c-44ed-85d8-c821a9c8c8488
895670quetiapine 150 MG 24 HR Extended Release Oral TabletSYd699b8c7-8a1c-44ed-85d8-c821a9c8c8488
721791quetiapine 200 MG (as quetiapine fumarate 230 MG) 24 HR Extended Release Oral TabletSYd699b8c7-8a1c-44ed-85d8-c821a9c8c8488
721791quetiapine 200 MG 24 HR Extended Release Oral TabletSYd699b8c7-8a1c-44ed-85d8-c821a9c8c8488
721794quetiapine 300 MG (as quetiapine fumarate 345 MG) 24 HR Extended Release Oral TabletSYd699b8c7-8a1c-44ed-85d8-c821a9c8c8488
721794quetiapine 300 MG 24 HR Extended Release Oral TabletSYd699b8c7-8a1c-44ed-85d8-c821a9c8c8488
721796quetiapine 400 MG (as quetiapine fumarate 461 MG) 24 HR Extended Release Oral TabletSYd699b8c7-8a1c-44ed-85d8-c821a9c8c8488

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
33342-134-093334201340960 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-134-09) 2017-11-010000-00-00NoNoCurrent
33342-134-1533342013415500 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-134-15) 2017-11-010000-00-00NoNoCurrent