Quetiapine

Product NDC
0093-8166
11-digit product format
000938166
Labeler code
0093
Product ID
0093-8166_5059f747-d59d-460b-99bc-7b76b235c094
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA077745
Marketing category
ANDA
Marketing start
2012-03-27
Substance
QUETIAPINE FUMARATE
Active strength
50 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0093-8166DDiscontinued by firm2026-08-03
excluded packagepackage0093-81660093-8166-01DDiscontinued by firm2026-08-03
excluded packagepackage0093-81660093-8166-10DDiscontinued by firm2026-08-03

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0093-8166-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0093-8166-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0093-8166-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0093-8166-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0093-8166-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0093-8166-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0093-8166-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0093-8166-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0093-8166-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0093-8166-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0093-8166-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0093-8166-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0093-8166-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0093-8166-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0093-8166-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0093-8166-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0093-8166-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0093-8166-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0093-8166-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0093-8166-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0093-8166-10367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0093-8166-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0093-8166-10557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0093-8166-01557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A077745-001QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-27
A077745-002QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-27
A077745-003QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-27
A077745-004QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2012-03-27
A077745-005QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-27
A077745-006QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-27
A077745-007QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 7 matching rows.

Application-product, TE code table
Application-productTE code
A077745-001AB
A077745-002AB
A077745-003AB
A077745-004AB
A077745-005AB
A077745-006AB
A077745-007AB

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 · 287 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077745-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077745-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077745-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077745-004QUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077745-005QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077745-006QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077745-007QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077745-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077745-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077745-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077745-004QUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077745-005QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077745-006QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077745-007QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A077745-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077745-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077745-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077745-004QUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077745-005QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077745-006QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077745-007QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077745-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077745-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077745-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077745-004QUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077745-005QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077745-006QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077745-007QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077745-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077745-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077745-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077745-004QUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077745-005QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077745-006QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077745-007QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077745-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077745-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077745-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077745-004QUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2012-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077745-005QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-2703ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 287 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077745-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077745-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077745-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077745-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077745-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077745-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077745-007AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077745-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077745-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077745-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077745-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077745-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077745-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077745-007AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077745-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077745-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077745-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077745-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077745-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077745-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077745-007AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077745-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077745-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077745-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077745-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077745-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077745-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077745-007AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077745-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077745-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077745-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077745-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077745-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077745-006AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077745-007AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077745-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077745-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077745-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077745-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077745-005AB103ed91905a0d…

Additional Listing Data#

Finished product
Yes
Brand name base
Quetiapine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
QUETIAPINE FUMARATE50 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 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312743Internal RxNorm lookup
312744Internal RxNorm lookup
312745Internal RxNorm lookup
317174Internal RxNorm lookup
616483Internal RxNorm lookup
616487Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c1d4ef59-bf58-44fe-9b46-1af42e2f7f8bAvailable 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
0093-8166-01Quetiapine100 in 1 BOTTLETABLET, FILM COATED10019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-8166-01EA - Each0093-81664f165def-a3e3-4ef4-ac9d-eb0cdb530e7712012-07-24
0093-8166-10EA - Each0093-81663f685bc3-8893-4fa8-90f8-21221dd489de12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
QUETIAPINE FUMARATEACTIVE INGREDIENT2S3PL1B6UJQUETIAPINE FUMARATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
QUETIAPINEACTIVE MOIETYBGL0JSY5SIQUETIAPINE FUMARATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933QUETIAPINE FUMARATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPQUETIAPINE FUMARATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UQUETIAPINE FUMARATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8QUETIAPINE FUMARATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTQUETIAPINE FUMARATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WQUETIAPINE FUMARATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82QUETIAPINE FUMARATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
HYPROMELLOSE 2910 (50 MPA.S)INACTIVE INGREDIENT1IVH67816NQUETIAPINE FUMARATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6QUETIAPINE FUMARATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XQUETIAPINE FUMARATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30QUETIAPINE FUMARATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEQUETIAPINE FUMARATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BQUETIAPINE FUMARATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
POVIDONE K25INACTIVE INGREDIENTK0KQV10C35QUETIAPINE FUMARATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
POVIDONE K26/28INACTIVE INGREDIENTH7AGY1OJO8QUETIAPINE FUMARATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4QUETIAPINE FUMARATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2QUETIAPINE FUMARATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPQUETIAPINE FUMARATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
TRIACETININACTIVE INGREDIENTXHX3C3X673QUETIAPINE FUMARATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
QUETIAPINE FUMARATEACTIVE INGREDIENT2S3PL1B6UJQUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]4
QUETIAPINE FUMARATEACTIVE INGREDIENT2S3PL1B6UJQUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
QUETIAPINEACTIVE MOIETYBGL0JSY5SIQUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]4
QUETIAPINEACTIVE MOIETYBGL0JSY5SIQUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]4
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933QUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPQUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPQUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UQUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UQUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8QUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTQUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTQUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]4
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WQUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WQUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]4
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82QUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]4
HYPROMELLOSE 2910 (50 MPA.S)INACTIVE INGREDIENT1IVH67816NQUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
HYPROMELLOSE 2910 (50 MPA.S)INACTIVE INGREDIENT1IVH67816NQUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]4
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6QUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XQUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XQUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30QUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEQUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]4
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEQUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BQUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]4
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BQUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
POVIDONE K25INACTIVE INGREDIENTK0KQV10C35QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]4
POVIDONE K25INACTIVE INGREDIENTK0KQV10C35QUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
POVIDONE K26/28INACTIVE INGREDIENTH7AGY1OJO8QUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
POVIDONE K26/28INACTIVE INGREDIENTH7AGY1OJO8QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4QUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2QUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPQUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPQUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]4
TRIACETININACTIVE INGREDIENTXHX3C3X673QUETIAPINE FUMARATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
TRIACETININACTIVE INGREDIENTXHX3C3X673QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]4
QUETIAPINE FUMARATEACTIVE INGREDIENT2S3PL1B6UJQUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
QUETIAPINEACTIVE MOIETYBGL0JSY5SIQUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPQUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UQUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
HYPROMELLOSE 2910 (50 MPA.S)INACTIVE INGREDIENT1IVH67816NQUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XQUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEQUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BQUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
POVIDONE K25INACTIVE INGREDIENTK0KQV10C35QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPQUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
TRIACETININACTIVE INGREDIENTXHX3C3X673QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-8166QUETIAPINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]18Current NDC, Legacy NDC, 1 package rows20250510_c1d4ef59-bf58-44fe-9b46-1af42e2f7f8b.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QuetiapineQUETIAPINETeva Pharmaceuticals USA, Inc.c1d4ef59-bf58-44fe-9b46-1af42e2f7f8b2025-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077745
application number: ANDA077745
ndc (product): 0093-8166
QuetiapineQUETIAPINEAphena Pharma Solutions - Tennessee, LLCfdece055-aeb5-43d6-b730-54dd74bde3042023-04-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077745
application number: ANDA077745
QuetiapineQUETIAPINEProficient Rx LPdd6b6088-943e-413b-9886-88dd9c622be42022-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077745
application number: ANDA077745
QuetiapineQUETIAPINEProficient Rx LP6258bbaf-4ac0-4621-b95e-e6b032aa05182020-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077745
application number: ANDA077745

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312743QUEtiapine fumarate 100 MG Oral TabletPSNc1d4ef59-bf58-44fe-9b46-1af42e2f7f8b19
317174QUEtiapine fumarate 200 MG Oral TabletPSNc1d4ef59-bf58-44fe-9b46-1af42e2f7f8b19
312744QUEtiapine fumarate 25 MG Oral TabletPSNc1d4ef59-bf58-44fe-9b46-1af42e2f7f8b19
312745QUEtiapine fumarate 300 MG Oral TabletPSNc1d4ef59-bf58-44fe-9b46-1af42e2f7f8b19
616483QUEtiapine fumarate 400 MG Oral TabletPSNc1d4ef59-bf58-44fe-9b46-1af42e2f7f8b19
616487QUEtiapine fumarate 50 MG Oral TabletPSNc1d4ef59-bf58-44fe-9b46-1af42e2f7f8b19
312743quetiapine 100 MG Oral TabletSCDc1d4ef59-bf58-44fe-9b46-1af42e2f7f8b19
317174quetiapine 200 MG Oral TabletSCDc1d4ef59-bf58-44fe-9b46-1af42e2f7f8b19
312744quetiapine 25 MG Oral TabletSCDc1d4ef59-bf58-44fe-9b46-1af42e2f7f8b19
312745quetiapine 300 MG Oral TabletSCDc1d4ef59-bf58-44fe-9b46-1af42e2f7f8b19
616483quetiapine 400 MG Oral TabletSCDc1d4ef59-bf58-44fe-9b46-1af42e2f7f8b19
616487quetiapine 50 MG Oral TabletSCDc1d4ef59-bf58-44fe-9b46-1af42e2f7f8b19
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSYc1d4ef59-bf58-44fe-9b46-1af42e2f7f8b19
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSYc1d4ef59-bf58-44fe-9b46-1af42e2f7f8b19
312744quetiapine (as quetiapine fumarate) 25 MG Oral TabletSYc1d4ef59-bf58-44fe-9b46-1af42e2f7f8b19
312745quetiapine (as quetiapine fumarate) 300 MG Oral TabletSYc1d4ef59-bf58-44fe-9b46-1af42e2f7f8b19
616483quetiapine (as quetiapine fumarate) 400 MG Oral TabletSYc1d4ef59-bf58-44fe-9b46-1af42e2f7f8b19
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSYc1d4ef59-bf58-44fe-9b46-1af42e2f7f8b19
312743QUEtiapine fumarate 100 MG Oral TabletPSN8a3fc038-aad1-6404-6ead-a4a55127cf4312
317174QUEtiapine fumarate 200 MG Oral TabletPSN8a3fc038-aad1-6404-6ead-a4a55127cf4312
312744QUEtiapine fumarate 25 MG Oral TabletPSN8a3fc038-aad1-6404-6ead-a4a55127cf4312
312745QUEtiapine fumarate 300 MG Oral TabletPSN8a3fc038-aad1-6404-6ead-a4a55127cf4312
616483QUEtiapine fumarate 400 MG Oral TabletPSN8a3fc038-aad1-6404-6ead-a4a55127cf4312
616487QUEtiapine fumarate 50 MG Oral TabletPSN8a3fc038-aad1-6404-6ead-a4a55127cf4312
312743quetiapine 100 MG Oral TabletSCD8a3fc038-aad1-6404-6ead-a4a55127cf4312
317174quetiapine 200 MG Oral TabletSCD8a3fc038-aad1-6404-6ead-a4a55127cf4312
312744quetiapine 25 MG Oral TabletSCD8a3fc038-aad1-6404-6ead-a4a55127cf4312
312745quetiapine 300 MG Oral TabletSCD8a3fc038-aad1-6404-6ead-a4a55127cf4312
616483quetiapine 400 MG Oral TabletSCD8a3fc038-aad1-6404-6ead-a4a55127cf4312
616487quetiapine 50 MG Oral TabletSCD8a3fc038-aad1-6404-6ead-a4a55127cf4312
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY8a3fc038-aad1-6404-6ead-a4a55127cf4312
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSY8a3fc038-aad1-6404-6ead-a4a55127cf4312
312744quetiapine (as quetiapine fumarate) 25 MG Oral TabletSY8a3fc038-aad1-6404-6ead-a4a55127cf4312
312745quetiapine (as quetiapine fumarate) 300 MG Oral TabletSY8a3fc038-aad1-6404-6ead-a4a55127cf4312
616483quetiapine (as quetiapine fumarate) 400 MG Oral TabletSY8a3fc038-aad1-6404-6ead-a4a55127cf4312
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSY8a3fc038-aad1-6404-6ead-a4a55127cf4312
616487QUEtiapine fumarate 50 MG Oral TabletPSNdaec35ae-a9e7-494a-90a6-c8aff1c65c712
616487quetiapine 50 MG Oral TabletSCDdaec35ae-a9e7-494a-90a6-c8aff1c65c712
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSYdaec35ae-a9e7-494a-90a6-c8aff1c65c712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-8166-0100093816601100 TABLET, FILM COATED in 1 BOTTLE (0093-8166-01) 2012-03-270000-00-00NoNoCurrent