Quetiapine fumarate

Product NDC
67046-0637
Requested package NDC
67046-0637-3
11-digit product format
670460637
Labeler code
67046
Product ID
67046-0637_52ba72f2-e3a4-89d2-e063-6294a90aa496
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
quetiapine
Dosage form
TABLET
Route
ORAL
Labeler
Coupler LLC
Application
ANDA201109
Marketing category
ANDA
Marketing start
2026-05-26
Substance
QUETIAPINE FUMARATE
Active strength
200 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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

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
A201109-001QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-27
A201109-002QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-27
A201109-003QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-27
A201109-004QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-27
A201109-005QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-27
A201109-006QUETIAPINE 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
A201109-001AB
A201109-002AB
A201109-003AB
A201109-004AB
A201109-005AB
A201109-006AB

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 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A201109-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A201109-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A201109-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A201109-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A201109-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A201109-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-2784e616aacf4f…
2026-08-18 06:07:402026-07A201109-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A201109-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A201109-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A201109-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A201109-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A201109-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201109-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201109-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201109-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201109-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201109-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201109-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201109-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201109-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201109-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201109-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201109-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201109-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A201109-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201109-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201109-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201109-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201109-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201109-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201109-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201109-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201109-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201109-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201109-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201109-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201109-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201109-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201109-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201109-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A201109-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A201109-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A201109-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A201109-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A201109-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A201109-006AB184e616aacf4f…
2026-08-18 06:07:402026-07A201109-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A201109-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A201109-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A201109-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A201109-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A201109-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201109-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201109-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201109-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201109-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201109-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201109-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201109-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201109-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201109-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201109-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201109-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201109-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201109-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201109-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201109-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201109-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201109-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201109-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201109-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201109-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201109-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201109-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201109-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201109-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201109-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201109-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201109-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201109-004AB1b8a1b40f171c…

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
Listing expiration
2027-12-31

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
317174Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
52ba669d-c846-03c2-e063-6394a90ac0f0Available 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
67046-0637-3Quetiapine fumarate30 in 1 BLISTER PACKTABLET301

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 2 · 30 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quetiapine fumarateQUETIAPINE FUMARATEPreferred Pharmaceuticals Inc.711f42c5-0719-46de-81fb-3d03801b9ed92026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201109
application number: ANDA201109
Quetiapine fumarateQUETIAPINE FUMARATENuCare Pharmaceuticals,Inc.227b8b2b-a238-efb4-e063-6394a90acc7e2026-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201109
application number: ANDA201109
Quetiapine fumarateQUETIAPINE FUMARATEREMEDYREPACK INC.c6c454c4-3eae-48ae-bf17-5dccdb6591412026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201109
application number: ANDA201109
Quetiapine fumarateQUETIAPINE FUMARATEREMEDYREPACK INC.d38f0f4e-dc0f-4c92-a212-c4da3db748012026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201109
application number: ANDA201109
Quetiapine fumarateQUETIAPINE FUMARATEREMEDYREPACK INC.ea9b9ed1-4be0-4dc0-b1dd-239caff5253e2026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201109
application number: ANDA201109
Quetiapine fumarateQUETIAPINE FUMARATEREMEDYREPACK INC.02b19885-2987-4c46-8d2a-5e59656f72e82026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201109
application number: ANDA201109
Quetiapine fumarateQUETIAPINE FUMARATEREMEDYREPACK INC.695415b1-083d-4540-9f41-bde4b201f8342026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201109
application number: ANDA201109
Quetiapine fumarateQUETIAPINE FUMARATEBryant Ranch Prepack94a81681-381e-4b3b-89ac-e86dcbe7f8902026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201109
application number: ANDA201109
Quetiapine fumarateQUETIAPINE FUMARATEBryant Ranch Prepackfd9cce28-0052-4b0b-8a66-a1615e082d952026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201109
application number: ANDA201109
Quetiapine fumarateQUETIAPINECoupler LLC5643d339-50ea-405d-e063-6394a90a3b702026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201109
application number: ANDA201109
Quetiapine fumarateQUETIAPINEUnit Dose Solutions, Inc.55f358e1-9458-b197-e063-6394a90a3f0e2026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201109
application number: ANDA201109
Quetiapine fumarateQUETIAPINE FUMARATEUnit Dose Solutions, Inc.55f574bc-ec55-93e2-e063-6394a90a1d472026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201109
application number: ANDA201109
Quetiapine fumarateQUETIAPINEUnit Dose Solutions, Inc.559fdce5-ab3e-0d02-e063-6394a90a7fbd2026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201109
application number: ANDA201109
Quetiapine fumarateQUETIAPINEUnit Dose Solutions, Inc.55a5671b-7771-0adf-e063-6294a90acfa62026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201109
application number: ANDA201109
Quetiapine fumarateQUETIAPINE FUMARATESt. Mary's Medical Park Pharmacy36248b77-277c-7d66-e063-6394a90ae1e82026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201109
application number: ANDA201109
Quetiapine fumarateQUETIAPINECoupler LLC544f6e91-e61f-c57a-e063-6294a90af9d12026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201109
application number: ANDA201109
Quetiapine fumarateQUETIAPINE FUMARATESt. Mary's Medical Park Pharmacy3624100f-6e3f-a2ad-e063-6294a90a0fc02026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201109
application number: ANDA201109
Quetiapine fumarateQUETIAPINE FUMARATELupin Pharmaceuticals, Inc.a951cd63-d329-47c9-965a-582fa73a07c62026-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201109
application number: ANDA201109
Quetiapine fumarateQUETIAPINECoupler LLC533154bb-a596-c88b-e063-6294a90a89562026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201109
application number: ANDA201109
Quetiapine fumarateQUETIAPINECoupler LLC52ba669d-c846-03c2-e063-6394a90ac0f02026-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201109
application number: ANDA201109
ndc (package): 67046-0637-3
ndc (product): 67046-0637
ndc11 (package): 67046063703

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317174QUEtiapine fumarate 200 MG Oral TabletPSN52ba669d-c846-03c2-e063-6394a90ac0f01
317174quetiapine 200 MG Oral TabletSCD52ba669d-c846-03c2-e063-6394a90ac0f01
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSY52ba669d-c846-03c2-e063-6394a90ac0f01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67046-0637-36704606370330 TABLET in 1 BLISTER PACK (67046-0637-3) 30 tablet2026-05-26NoNoCurrent