FDA.reportPublic FDA data

QUETIAPINE

Product NDC
33342-137
11-digit product format
333420137
Labeler code
33342
Product ID
33342-137_fb91b782-1195-4212-b130-9e078dc47dcd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
QUETIAPINE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA204253
Marketing category
ANDA
Marketing start
2017-11-01
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
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, 895670

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5ef42f82-f087-0d2c-105f-f791ca69210eProduct name820250729
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
21205abd-8c89-4943-9f85-908f3d4fc3bbProduct name520230501
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33342-137-09QUETIAPINE60 in 1 BOTTLETABLET, EXTENDED RELEASE608
33342-137-15QUETIAPINE500 in 1 BOTTLETABLET, EXTENDED RELEASE5008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-137-09EA - Each33342-13766fbb6c3-221f-419c-9e81-8bea8f84f8c212018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-137QUETIAPINE TABLET, EXTENDED RELEASE [MACLEODS PHARMACEUTICALS LIMITED]8Current NDC, Legacy NDC, 2 package rows20230801_d699b8c7-8a1c-44ed-85d8-c821a9c8c848.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895670QUEtiapine fumarate 150 MG 24HR Extended Release Oral TabletPSNd699b8c7-8a1c-44ed-85d8-c821a9c8c8488
721791QUEtiapine fumarate 200 MG 24HR Extended Release Oral TabletPSNd699b8c7-8a1c-44ed-85d8-c821a9c8c8488
721794QUEtiapine fumarate 300 MG 24HR Extended Release Oral TabletPSNd699b8c7-8a1c-44ed-85d8-c821a9c8c8488
721796QUEtiapine fumarate 400 MG 24HR Extended Release Oral TabletPSNd699b8c7-8a1c-44ed-85d8-c821a9c8c8488
89567024 HR quetiapine 150 MG Extended Release Oral TabletSCDd699b8c7-8a1c-44ed-85d8-c821a9c8c8488
72179124 HR quetiapine 200 MG Extended Release Oral TabletSCDd699b8c7-8a1c-44ed-85d8-c821a9c8c8488
72179424 HR quetiapine 300 MG Extended Release Oral TabletSCDd699b8c7-8a1c-44ed-85d8-c821a9c8c8488
72179624 HR quetiapine 400 MG Extended Release Oral TabletSCDd699b8c7-8a1c-44ed-85d8-c821a9c8c8488
895670quetiapine 150 MG (as quetiapine fumarate 173 MG) 24 HR Extended Release Oral TabletSYd699b8c7-8a1c-44ed-85d8-c821a9c8c8488
895670quetiapine 150 MG 24 HR Extended Release Oral TabletSYd699b8c7-8a1c-44ed-85d8-c821a9c8c8488
721791quetiapine 200 MG (as quetiapine fumarate 230 MG) 24 HR Extended Release Oral TabletSYd699b8c7-8a1c-44ed-85d8-c821a9c8c8488
721791quetiapine 200 MG 24 HR Extended Release Oral TabletSYd699b8c7-8a1c-44ed-85d8-c821a9c8c8488
721794quetiapine 300 MG (as quetiapine fumarate 345 MG) 24 HR Extended Release Oral TabletSYd699b8c7-8a1c-44ed-85d8-c821a9c8c8488
721794quetiapine 300 MG 24 HR Extended Release Oral TabletSYd699b8c7-8a1c-44ed-85d8-c821a9c8c8488
721796quetiapine 400 MG (as quetiapine fumarate 461 MG) 24 HR Extended Release Oral TabletSYd699b8c7-8a1c-44ed-85d8-c821a9c8c8488
721796QUEtiapine fumarate 400 MG 24HR Extended Release Oral TabletPSNb78b4e12-8ec4-470d-9bb5-665b5af328f51
721796QUEtiapine fumarate 400 MG 24HR Extended Release Oral TabletPSN3fb5c81f-ce5f-98bf-e063-6294a90a57111
72179624 HR quetiapine 400 MG Extended Release Oral TabletSCDb78b4e12-8ec4-470d-9bb5-665b5af328f51
72179624 HR quetiapine 400 MG Extended Release Oral TabletSCD3fb5c81f-ce5f-98bf-e063-6294a90a57111
721796quetiapine 400 MG (as quetiapine fumarate 461 MG) 24 HR Extended Release Oral TabletSY3fb5c81f-ce5f-98bf-e063-6294a90a57111
721796quetiapine 400 MG (as quetiapine fumarate 461 MG) 24 HR Extended Release Oral TabletSYb78b4e12-8ec4-470d-9bb5-665b5af328f51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
33342-137-093334201370960 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-137-09) 2017-11-010000-00-00NoNoCurrent
33342-137-1533342013715500 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-137-15) 2017-11-010000-00-00NoNoCurrent