Quetiapine Fumarate

Product NDC
31722-765
11-digit product format
317220765
Labeler code
31722
Product ID
31722-765_6c68f74f-289f-4d3a-a0a7-ad6173b6628c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine Fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA204316
Marketing category
ANDA
Marketing start
2022-06-16
Substance
QUETIAPINE FUMARATE
Active strength
50 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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204316-001QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2022-06-16
A204316-002QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2022-06-16
A204316-003QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2022-06-16
A204316-004QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2022-06-16
A204316-005QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2022-06-16
A204316-006QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2022-06-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
A204316-001AB
A204316-002AB
A204316-003AB
A204316-004AB
A204316-005AB
A204316-006AB

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 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A204316-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2022-06-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204316-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2022-06-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204316-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2022-06-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204316-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2022-06-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204316-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2022-06-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204316-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2022-06-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204316-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2022-06-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204316-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2022-06-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204316-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2022-06-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204316-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2022-06-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204316-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2022-06-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204316-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2022-06-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A204316-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2022-06-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204316-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2022-06-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204316-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2022-06-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204316-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2022-06-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204316-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2022-06-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204316-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2022-06-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204316-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2022-06-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204316-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2022-06-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204316-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2022-06-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204316-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2022-06-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204316-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2022-06-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204316-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2022-06-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204316-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2022-06-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204316-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2022-06-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204316-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2022-06-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204316-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2022-06-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204316-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2022-06-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204316-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2022-06-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204316-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2022-06-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204316-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2022-06-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204316-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2022-06-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204316-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2022-06-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204316-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2022-06-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204316-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2022-06-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204316-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2022-06-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204316-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2022-06-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204316-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2022-06-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204316-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2022-06-162680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A204316-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204316-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204316-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204316-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204316-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204316-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204316-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204316-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204316-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204316-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204316-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204316-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204316-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204316-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204316-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204316-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204316-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204316-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204316-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204316-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204316-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204316-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204316-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204316-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204316-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204316-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204316-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204316-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204316-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204316-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204316-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204316-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204316-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204316-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204316-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204316-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204316-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204316-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204316-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204316-004AB12680178bc6a6…

Additional Listing Data#

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

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
5c6aeb85-3ac2-4448-b544-9a4c5f562ed3Available 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
31722-765-01Quetiapine Fumarate100 in 1 BOTTLETABLET, FILM COATED1004
31722-765-05Quetiapine Fumarate500 in 1 BOTTLETABLET, FILM COATED5004
31722-765-31Quetiapine Fumarate10 in 1 BLISTER PACKTABLET, FILM COATED104
31722-765-32Quetiapine Fumarate100 in 1 CARTONTABLET, FILM COATED1004
31722-765-33Quetiapine Fumarate10 in 1 BLISTER PACKTABLET, FILM COATED104
31722-765-34Quetiapine Fumarate100 in 1 CARTONTABLET, FILM COATED1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-765-01EA - Each31722-7656bea731c-3d31-44fe-ae5a-1ec6a05d72ec12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-765QUETIAPINE FUMARATE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 6 package rows20250410_5c6aeb85-3ac2-4448-b544-9a4c5f562ed3.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quetiapine FumarateQUETIAPINE FUMARATEREMEDYREPACK INC.3085f68d-e83c-4f59-b058-8bdae7f4e5372026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204316
application number: ANDA204316
Quetiapine FumarateQUETIAPINE FUMARATEREMEDYREPACK INC.b8864cb9-1c6a-4e36-9893-eb1403ee87452026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204316
application number: ANDA204316
Quetiapine FumarateQUETIAPINE FUMARATEXLCare Pharmaceuticals Inc.070faf07-0ce7-4354-8643-9d222b72ecad2026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204316
application number: ANDA204316
Quetiapine FumarateQUETIAPINE FUMARATEST. MARY'S MEDICAL PARK PHARMACY3624c430-2a17-a83a-e063-6394a90add932025-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204316
application number: ANDA204316
Quetiapine FumarateQUETIAPINE FUMARATECamber Pharmaceuticals, Inc.5c6aeb85-3ac2-4448-b544-9a4c5f562ed32024-04-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204316
application number: ANDA204316
ndc (product): 31722-765

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312743QUEtiapine fumarate 100 MG Oral TabletPSN5c6aeb85-3ac2-4448-b544-9a4c5f562ed34
317174QUEtiapine fumarate 200 MG Oral TabletPSN5c6aeb85-3ac2-4448-b544-9a4c5f562ed34
312744QUEtiapine fumarate 25 MG Oral TabletPSN5c6aeb85-3ac2-4448-b544-9a4c5f562ed34
312745QUEtiapine fumarate 300 MG Oral TabletPSN5c6aeb85-3ac2-4448-b544-9a4c5f562ed34
616483QUEtiapine fumarate 400 MG Oral TabletPSN5c6aeb85-3ac2-4448-b544-9a4c5f562ed34
616487QUEtiapine fumarate 50 MG Oral TabletPSN5c6aeb85-3ac2-4448-b544-9a4c5f562ed34
312743quetiapine 100 MG Oral TabletSCD5c6aeb85-3ac2-4448-b544-9a4c5f562ed34
317174quetiapine 200 MG Oral TabletSCD5c6aeb85-3ac2-4448-b544-9a4c5f562ed34
312744quetiapine 25 MG Oral TabletSCD5c6aeb85-3ac2-4448-b544-9a4c5f562ed34
312745quetiapine 300 MG Oral TabletSCD5c6aeb85-3ac2-4448-b544-9a4c5f562ed34
616483quetiapine 400 MG Oral TabletSCD5c6aeb85-3ac2-4448-b544-9a4c5f562ed34
616487quetiapine 50 MG Oral TabletSCD5c6aeb85-3ac2-4448-b544-9a4c5f562ed34
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY5c6aeb85-3ac2-4448-b544-9a4c5f562ed34
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSY5c6aeb85-3ac2-4448-b544-9a4c5f562ed34
312744quetiapine (as quetiapine fumarate) 25 MG Oral TabletSY5c6aeb85-3ac2-4448-b544-9a4c5f562ed34
312745quetiapine (as quetiapine fumarate) 300 MG Oral TabletSY5c6aeb85-3ac2-4448-b544-9a4c5f562ed34
616483quetiapine (as quetiapine fumarate) 400 MG Oral TabletSY5c6aeb85-3ac2-4448-b544-9a4c5f562ed34
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSY5c6aeb85-3ac2-4448-b544-9a4c5f562ed34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-765-0131722076501100 TABLET, FILM COATED in 1 BOTTLE (31722-765-01) 2022-06-160000-00-00NoNoCurrent
31722-765-0531722076505500 TABLET, FILM COATED in 1 BOTTLE (31722-765-05) 2022-06-160000-00-00NoNoCurrent
31722-765-313172207653110 in 1 BLISTER PACKHistorical
31722-765-3231722076532100 BLISTER PACK in 1 CARTON (31722-765-32) / 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-765-31) 100 blister pack2022-06-160000-00-00NoNoCurrent
31722-765-333172207653310 in 1 BLISTER PACKHistorical
31722-765-3431722076534100 BLISTER PACK in 1 CARTON (31722-765-34) / 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-765-33) 100 blister pack2022-06-160000-00-00NoNoCurrent