QUETIAPINE

Product NDC
43547-023
11-digit product format
435470023
Labeler code
43547
Product ID
43547-023_058aac79-3e9f-46b2-a2f8-693ffb211aef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
quetiapine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Solco Healthcare U.S., LLC
Application
ANDA208781
Marketing category
ANDA
Marketing start
2022-04-01
Substance
QUETIAPINE
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 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208781-001QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-26
A208781-002QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-26
A208781-003QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-26
A208781-004QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-26
A208781-005QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2024-03-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A208781-001AB
A208781-002AB
A208781-003AB
A208781-004AB
A208781-005AB

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 4 · 131 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A208781-001QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208781-002QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208781-003QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208781-004QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208781-005QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2024-03-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208781-001QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208781-002QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208781-003QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208781-004QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208781-005QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2024-03-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208781-001QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208781-002QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208781-003QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208781-004QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208781-005QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2024-03-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208781-001QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208781-002QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208781-003QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208781-004QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208781-005QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2024-03-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208781-001QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208781-002QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208781-003QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208781-004QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208781-005QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2024-03-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208781-001QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208781-002QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208781-003QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208781-004QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208781-005QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2024-03-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208781-001QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208781-002QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208781-003QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208781-004QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208781-005QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2024-03-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208781-001QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208781-002QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208781-003QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208781-004QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208781-005QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2024-03-115bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 131 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A208781-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208781-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208781-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208781-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208781-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208781-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208781-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208781-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208781-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208781-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208781-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208781-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208781-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208781-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208781-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208781-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208781-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208781-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208781-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208781-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208781-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208781-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208781-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208781-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208781-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208781-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208781-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208781-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208781-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208781-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208781-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208781-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208781-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208781-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208781-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208781-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208781-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208781-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208781-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208781-005AB15bbf6a4d5a75…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
QUETIAPINE400 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
BGL0JSY5SIInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
721791Internal RxNorm lookup
721794Internal RxNorm lookup
721796Internal RxNorm lookup
853201Internal 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
b0cce89c-0e84-4f60-8e50-0e26c41c2613Available 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
43547-023-06QUETIAPINE60 in 1 BOTTLETABLET, EXTENDED RELEASE602
43547-023-50QUETIAPINE500 in 1 BOTTLETABLET, EXTENDED RELEASE5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-023QUETIAPINE TABLET, EXTENDED RELEASE [SOLCO HEALTHCARE U.S., LLC]2Current NDC, 2 package rows20240606_b0cce89c-0e84-4f60-8e50-0e26c41c2613.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QUETIAPINEQUETIAPINESolco Healthcare U.S., LLCb0cce89c-0e84-4f60-8e50-0e26c41c26132023-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208781
application number: ANDA208781
ndc (product): 43547-023

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895670QUEtiapine fumarate 150 MG 24HR Extended Release Oral TabletPSNb0cce89c-0e84-4f60-8e50-0e26c41c26132
721791QUEtiapine fumarate 200 MG 24HR Extended Release Oral TabletPSNb0cce89c-0e84-4f60-8e50-0e26c41c26132
721794QUEtiapine fumarate 300 MG 24HR Extended Release Oral TabletPSNb0cce89c-0e84-4f60-8e50-0e26c41c26132
721796QUEtiapine fumarate 400 MG 24HR Extended Release Oral TabletPSNb0cce89c-0e84-4f60-8e50-0e26c41c26132
853201QUEtiapine fumarate 50 MG 24HR Extended Release Oral TabletPSNb0cce89c-0e84-4f60-8e50-0e26c41c26132
89567024 HR quetiapine 150 MG Extended Release Oral TabletSCDb0cce89c-0e84-4f60-8e50-0e26c41c26132
72179124 HR quetiapine 200 MG Extended Release Oral TabletSCDb0cce89c-0e84-4f60-8e50-0e26c41c26132
72179424 HR quetiapine 300 MG Extended Release Oral TabletSCDb0cce89c-0e84-4f60-8e50-0e26c41c26132
72179624 HR quetiapine 400 MG Extended Release Oral TabletSCDb0cce89c-0e84-4f60-8e50-0e26c41c26132
85320124 HR quetiapine 50 MG Extended Release Oral TabletSCDb0cce89c-0e84-4f60-8e50-0e26c41c26132
895670quetiapine 150 MG (as quetiapine fumarate 173 MG) 24 HR Extended Release Oral TabletSYb0cce89c-0e84-4f60-8e50-0e26c41c26132
895670quetiapine 150 MG 24 HR Extended Release Oral TabletSYb0cce89c-0e84-4f60-8e50-0e26c41c26132
721791quetiapine 200 MG (as quetiapine fumarate 230 MG) 24 HR Extended Release Oral TabletSYb0cce89c-0e84-4f60-8e50-0e26c41c26132
721791quetiapine 200 MG 24 HR Extended Release Oral TabletSYb0cce89c-0e84-4f60-8e50-0e26c41c26132
721794quetiapine 300 MG (as quetiapine fumarate 345 MG) 24 HR Extended Release Oral TabletSYb0cce89c-0e84-4f60-8e50-0e26c41c26132
721794quetiapine 300 MG 24 HR Extended Release Oral TabletSYb0cce89c-0e84-4f60-8e50-0e26c41c26132
721796quetiapine 400 MG (as quetiapine fumarate 461 MG) 24 HR Extended Release Oral TabletSYb0cce89c-0e84-4f60-8e50-0e26c41c26132
853201quetiapine 50 MG (as quetiapine fumarate 58 MG) 24 HR Extended Release Oral TabletSYb0cce89c-0e84-4f60-8e50-0e26c41c26132
853201quetiapine 50 MG 24 HR Extended Release Oral TabletSYb0cce89c-0e84-4f60-8e50-0e26c41c26132

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
43547-023-064354700230660 TABLET, EXTENDED RELEASE in 1 BOTTLE (43547-023-06) 2022-04-01NoNoCurrent
43547-023-5043547002350500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43547-023-50) 2022-04-01NoNoCurrent