Quetiapine Fumarate ER

Product NDC
72189-519
11-digit product format
721890519
Labeler code
72189
Product ID
72189-519_2c4e7611-7a3a-f31d-e063-6394a90a236f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine Fumarate ER
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA209635
Marketing category
ANDA
Marketing start
2023-11-01
Substance
QUETIAPINE FUMARATE
Active strength
200 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage72189-519-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72189-519-300efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A209635-001QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29
A209635-002QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29
A209635-003QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29
A209635-004QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29
A209635-005QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2018-11-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209635-001AB
A209635-002AB
A209635-003AB
A209635-004AB
A209635-005AB

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 6 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A209635-001QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2984e616aacf4f…
2026-09-14 22:38:342026-08A209635-002QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2984e616aacf4f…
2026-09-14 22:38:342026-08A209635-003QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2984e616aacf4f…
2026-09-14 22:38:342026-08A209635-004QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2984e616aacf4f…
2026-09-14 22:38:342026-08A209635-005QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2018-11-1684e616aacf4f…
2026-08-18 06:07:402026-07A209635-001QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29caaa826d4ba7…
2026-08-18 06:07:402026-07A209635-002QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29caaa826d4ba7…
2026-08-18 06:07:402026-07A209635-003QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29caaa826d4ba7…
2026-08-18 06:07:402026-07A209635-004QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29caaa826d4ba7…
2026-08-18 06:07:402026-07A209635-005QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2018-11-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209635-001QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209635-002QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209635-003QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209635-004QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209635-005QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2018-11-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209635-001QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209635-002QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209635-003QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209635-004QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209635-005QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2018-11-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A209635-001QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209635-002QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209635-003QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209635-004QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209635-005QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2018-11-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209635-001QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209635-002QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209635-003QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209635-004QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209635-005QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2018-11-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209635-001QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209635-002QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209635-003QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209635-004QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209635-005QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2018-11-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209635-001QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209635-002QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209635-003QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209635-004QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209635-005QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2018-11-1603ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A209635-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A209635-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A209635-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A209635-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A209635-005AB184e616aacf4f…
2026-08-18 06:07:402026-07A209635-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209635-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209635-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209635-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209635-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209635-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209635-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209635-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209635-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209635-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209635-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209635-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209635-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209635-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209635-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209635-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209635-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209635-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209635-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209635-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209635-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209635-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209635-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209635-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209635-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209635-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209635-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209635-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209635-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209635-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209635-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209635-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209635-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209635-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209635-005AB103ed91905a0d…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Quetiapine Fumarate ER
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
QUETIAPINE FUMARATE200 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
721791Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0917ef53-2647-b54b-e063-6294a90a4211Available 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
72189-519-30Quetiapine Fumarate ER30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-519-30EA - Each72189-51926a2794c-139b-47cc-bfca-60b7c47b711712023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-519QUETIAPINE FUMARATE ER TABLET, FILM COATED, EXTENDED RELEASE [DIRECT_RX]2Current NDC, 1 package rows20250123_0917ef53-2647-b54b-e063-6294a90a4211.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
Quetiapine Extended ReleaseQUETIAPINEREMEDYREPACK INC.995731f7-aace-4140-b699-d6e8975c7c832026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209635
application number: ANDA209635
Quetiapine Extended ReleaseQUETIAPINENuCare Pharmaceuticals, Inc.44e9b338-b163-bee7-e063-6394a90a13382025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209635
application number: ANDA209635
Quetiapine Extended ReleaseQUETIAPINEGolden State Medical Supply, Inc.04cd529c-198b-5b85-e063-6294a90a46842025-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209635
application number: ANDA209635
Quetiapine Extended ReleaseQUETIAPINEST. MARY'S MEDICAL PARK PHARMACY3622cbd4-d7cb-57d4-e063-6294a90a5f242025-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209635
application number: ANDA209635
Quetiapine Extended ReleaseQUETIAPINEScieGen Pharmaceuticals, Inc5e4a84b1-fb8c-44d0-8213-51e43d71db692025-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209635
application number: ANDA209635
Quetiapine Fumarate ERQUETIAPINE FUMARATE ERDirect_Rx0917ef53-2647-b54b-e063-6294a90a42112025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209635
application number: ANDA209635
ndc (product): 72189-519
Quetiapine Fumarate ERQUETIAPINE FUMARATE ERDirect_rx23820efc-4df7-9dc9-e063-6394a90a0bb42024-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209635
application number: ANDA209635
Quetiapine Extended ReleaseQUETIAPINEACI Healthcare USA, Inc.07e4f3f4-42cb-4b22-bf8d-8c3279d26e972021-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209635
application number: ANDA209635

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
721791QUEtiapine fumarate 200 MG 24HR Extended Release Oral TabletPSN0917ef53-2647-b54b-e063-6294a90a42112
72179124 HR quetiapine 200 MG Extended Release Oral TabletSCD0917ef53-2647-b54b-e063-6294a90a42112
721791quetiapine 200 MG (as quetiapine fumarate 230 MG) 24 HR Extended Release Oral TabletSY0917ef53-2647-b54b-e063-6294a90a42112
721791quetiapine 200 MG 24 HR Extended Release Oral TabletSY0917ef53-2647-b54b-e063-6294a90a42112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72189-519-307218905193030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72189-519-30) 2023-11-01NoNoCurrent