Quetiapine

Product NDC
67046-361
Requested package NDC
67046-361-30
11-digit product format
670460361
Labeler code
67046
Product ID
67046-361_a9077873-ce4d-8b7a-e053-2a95a90a64cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA202152
Marketing category
ANDA
Marketing start
2012-03-28
Marketing end
0000-00-00
Substance
QUETIAPINE FUMARATE
Active strength
50 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67046-36167046-361-30IInactivated by FDA2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

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…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5ef42f82-f087-0d2c-105f-f791ca69210eProduct name820250729
21205abd-8c89-4943-9f85-908f3d4fc3bbProduct name520230501

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-361-30Quetiapine30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-361QUETIAPINE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 1 package rows20200627_a90798e4-2600-407a-e053-2a95a90a3df7.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
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
616487QUEtiapine fumarate 50 MG Oral TabletPSNa90798e4-2600-407a-e053-2a95a90a3df71
616487quetiapine 50 MG Oral TabletSCDa90798e4-2600-407a-e053-2a95a90a3df71
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSYa90798e4-2600-407a-e053-2a95a90a3df71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67046-361-306704603613030 TABLET, FILM COATED in 1 BLISTER PACK (67046-361-30) 2012-03-280000-00-00NoNoCurrent