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

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 Identifiers#

Field, Values table
FieldValues
Unii2S3PL1B6UJ
Rxcui721791, 721794, 721796, 853201, 895670

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