FDA.reportPublic FDA data

Quetiapine

Product NDC
71093-139
11-digit product format
710930139
Labeler code
71093
Product ID
71093-139_8a3515c7-6fc7-4150-a898-23443e4802fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
ACI Healthcare USA, Inc.
Application
ANDA209635
Marketing category
ANDA
Marketing start
2017-11-29
Substance
QUETIAPINE FUMARATE
Active strength
400 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 · 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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A209635-001QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29a50c72e98297…
2026-08-01 22:54:322026-06A209635-002QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29a50c72e98297…
2026-08-01 22:54:322026-06A209635-003QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29a50c72e98297…
2026-08-01 22:54:322026-06A209635-004QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29a50c72e98297…
2026-08-01 22:54:322026-06A209635-005QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2018-11-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209635-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A209635-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A209635-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A209635-004AB1a50c72e98297…
2026-08-01 22:54:322026-06A209635-005AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
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
ndc (product): 71093-139

Additional Listing Data#

Finished product
Yes
Brand name base
Quetiapine
Brand name suffix
Extended Release
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
QUETIAPINE FUMARATE400 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 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
721791Internal RxNorm lookup
721794Internal RxNorm lookup
721796Internal RxNorm lookup
853201Internal RxNorm lookup
895670Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
07e4f3f4-42cb-4b22-bf8d-8c3279d26e97Available 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
71093-139-02QuetiapineExtended Release60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71093-139-02EA - Each71093-1393008fc59-ba17-4b4e-9543-fba4b5f83bcf12018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71093-139QUETIAPINE EXTENDED RELEASE (QUETIAPINE) TABLET, FILM COATED, EXTENDED RELEASE [ACI HEALTHCARE USA, INC.]6Current NDC, Legacy NDC, 1 package rows20210129_07e4f3f4-42cb-4b22-bf8d-8c3279d26e97.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895670QUEtiapine fumarate 150 MG 24HR Extended Release Oral TabletPSN07e4f3f4-42cb-4b22-bf8d-8c3279d26e976
721791QUEtiapine fumarate 200 MG 24HR Extended Release Oral TabletPSN07e4f3f4-42cb-4b22-bf8d-8c3279d26e976
721794QUEtiapine fumarate 300 MG 24HR Extended Release Oral TabletPSN07e4f3f4-42cb-4b22-bf8d-8c3279d26e976
721796QUEtiapine fumarate 400 MG 24HR Extended Release Oral TabletPSN07e4f3f4-42cb-4b22-bf8d-8c3279d26e976
853201QUEtiapine fumarate 50 MG 24HR Extended Release Oral TabletPSN07e4f3f4-42cb-4b22-bf8d-8c3279d26e976
89567024 HR quetiapine 150 MG Extended Release Oral TabletSCD07e4f3f4-42cb-4b22-bf8d-8c3279d26e976
72179124 HR quetiapine 200 MG Extended Release Oral TabletSCD07e4f3f4-42cb-4b22-bf8d-8c3279d26e976
72179424 HR quetiapine 300 MG Extended Release Oral TabletSCD07e4f3f4-42cb-4b22-bf8d-8c3279d26e976
72179624 HR quetiapine 400 MG Extended Release Oral TabletSCD07e4f3f4-42cb-4b22-bf8d-8c3279d26e976
85320124 HR quetiapine 50 MG Extended Release Oral TabletSCD07e4f3f4-42cb-4b22-bf8d-8c3279d26e976
895670quetiapine 150 MG (as quetiapine fumarate 173 MG) 24 HR Extended Release Oral TabletSY07e4f3f4-42cb-4b22-bf8d-8c3279d26e976
895670quetiapine 150 MG 24 HR Extended Release Oral TabletSY07e4f3f4-42cb-4b22-bf8d-8c3279d26e976
721791quetiapine 200 MG (as quetiapine fumarate 230 MG) 24 HR Extended Release Oral TabletSY07e4f3f4-42cb-4b22-bf8d-8c3279d26e976
721791quetiapine 200 MG 24 HR Extended Release Oral TabletSY07e4f3f4-42cb-4b22-bf8d-8c3279d26e976
721794quetiapine 300 MG (as quetiapine fumarate 345 MG) 24 HR Extended Release Oral TabletSY07e4f3f4-42cb-4b22-bf8d-8c3279d26e976
721794quetiapine 300 MG 24 HR Extended Release Oral TabletSY07e4f3f4-42cb-4b22-bf8d-8c3279d26e976
721796quetiapine 400 MG (as quetiapine fumarate 461 MG) 24 HR Extended Release Oral TabletSY07e4f3f4-42cb-4b22-bf8d-8c3279d26e976
853201quetiapine 50 MG (as quetiapine fumarate 58 MG) 24 HR Extended Release Oral TabletSY07e4f3f4-42cb-4b22-bf8d-8c3279d26e976
853201quetiapine 50 MG 24 HR Extended Release Oral TabletSY07e4f3f4-42cb-4b22-bf8d-8c3279d26e976

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71093-139-027109301390260 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71093-139-02) 2018-02-010000-00-00NoNoCurrent