FDA.reportPublic FDA data

Quetiapine Fumarate

Product NDC
29300-152
11-digit product format
293000152
Labeler code
29300
Product ID
29300-152_9054a1a7-c7ea-4630-be0b-2dcbe910ca94
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine Fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA202674
Marketing category
ANDA
Marketing start
2016-07-01
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 Fumarate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
QUETIAPINE FUMARATE400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S3PL1B6UJ
Rxcui312743, 312744, 312745, 317174, 616483, 616487

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
29300-152-01Quetiapine Fumarate100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10020
29300-152-05Quetiapine Fumarate500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50020
29300-152-16Quetiapine Fumarate60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-152-01EA - Each29300-15268a8308f-05aa-49e4-b296-5d6dbd69b71812016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-152QUETIAPINE FUMARATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]20Current NDC, Legacy NDC, 3 package rows20250226_bdc9354b-172e-4bb3-895a-6c7cfef0ef14.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312743QUEtiapine fumarate 100 MG Oral TabletPSNd73655d3-4b3f-40b4-92cb-053ad4f21a9220
312743QUEtiapine fumarate 100 MG Oral TabletPSNbdc9354b-172e-4bb3-895a-6c7cfef0ef1420
317174QUEtiapine fumarate 200 MG Oral TabletPSNbdc9354b-172e-4bb3-895a-6c7cfef0ef1420
317174QUEtiapine fumarate 200 MG Oral TabletPSNd73655d3-4b3f-40b4-92cb-053ad4f21a9220
312744QUEtiapine fumarate 25 MG Oral TabletPSNd73655d3-4b3f-40b4-92cb-053ad4f21a9220
312744QUEtiapine fumarate 25 MG Oral TabletPSNbdc9354b-172e-4bb3-895a-6c7cfef0ef1420
312745QUEtiapine fumarate 300 MG Oral TabletPSNbdc9354b-172e-4bb3-895a-6c7cfef0ef1420
312745QUEtiapine fumarate 300 MG Oral TabletPSNd73655d3-4b3f-40b4-92cb-053ad4f21a9220
616483QUEtiapine fumarate 400 MG Oral TabletPSNbdc9354b-172e-4bb3-895a-6c7cfef0ef1420
616483QUEtiapine fumarate 400 MG Oral TabletPSNd73655d3-4b3f-40b4-92cb-053ad4f21a9220
616487QUEtiapine fumarate 50 MG Oral TabletPSNbdc9354b-172e-4bb3-895a-6c7cfef0ef1420
616487QUEtiapine fumarate 50 MG Oral TabletPSNd73655d3-4b3f-40b4-92cb-053ad4f21a9220
312743quetiapine 100 MG Oral TabletSCDd73655d3-4b3f-40b4-92cb-053ad4f21a9220
312743quetiapine 100 MG Oral TabletSCDbdc9354b-172e-4bb3-895a-6c7cfef0ef1420
317174quetiapine 200 MG Oral TabletSCDbdc9354b-172e-4bb3-895a-6c7cfef0ef1420
317174quetiapine 200 MG Oral TabletSCDd73655d3-4b3f-40b4-92cb-053ad4f21a9220
312744quetiapine 25 MG Oral TabletSCDbdc9354b-172e-4bb3-895a-6c7cfef0ef1420
312744quetiapine 25 MG Oral TabletSCDd73655d3-4b3f-40b4-92cb-053ad4f21a9220
312745quetiapine 300 MG Oral TabletSCDbdc9354b-172e-4bb3-895a-6c7cfef0ef1420
312745quetiapine 300 MG Oral TabletSCDd73655d3-4b3f-40b4-92cb-053ad4f21a9220
616483quetiapine 400 MG Oral TabletSCDbdc9354b-172e-4bb3-895a-6c7cfef0ef1420
616483quetiapine 400 MG Oral TabletSCDd73655d3-4b3f-40b4-92cb-053ad4f21a9220
616487quetiapine 50 MG Oral TabletSCDd73655d3-4b3f-40b4-92cb-053ad4f21a9220
616487quetiapine 50 MG Oral TabletSCDbdc9354b-172e-4bb3-895a-6c7cfef0ef1420
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSYd73655d3-4b3f-40b4-92cb-053ad4f21a9220
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSYbdc9354b-172e-4bb3-895a-6c7cfef0ef1420
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSYd73655d3-4b3f-40b4-92cb-053ad4f21a9220
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSYbdc9354b-172e-4bb3-895a-6c7cfef0ef1420
312744quetiapine (as quetiapine fumarate) 25 MG Oral TabletSYbdc9354b-172e-4bb3-895a-6c7cfef0ef1420
312744quetiapine (as quetiapine fumarate) 25 MG Oral TabletSYd73655d3-4b3f-40b4-92cb-053ad4f21a9220
312745quetiapine (as quetiapine fumarate) 300 MG Oral TabletSYd73655d3-4b3f-40b4-92cb-053ad4f21a9220
312745quetiapine (as quetiapine fumarate) 300 MG Oral TabletSYbdc9354b-172e-4bb3-895a-6c7cfef0ef1420
616483quetiapine (as quetiapine fumarate) 400 MG Oral TabletSYd73655d3-4b3f-40b4-92cb-053ad4f21a9220
616483quetiapine (as quetiapine fumarate) 400 MG Oral TabletSYbdc9354b-172e-4bb3-895a-6c7cfef0ef1420
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSYd73655d3-4b3f-40b4-92cb-053ad4f21a9220
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSYbdc9354b-172e-4bb3-895a-6c7cfef0ef1420
616483QUEtiapine fumarate 400 MG Oral TabletPSNfb10b12a-0017-47a2-9826-e403ac6a77a71
616483quetiapine 400 MG Oral TabletSCDfb10b12a-0017-47a2-9826-e403ac6a77a71
616483quetiapine (as quetiapine fumarate) 400 MG Oral TabletSYfb10b12a-0017-47a2-9826-e403ac6a77a71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
29300-152-0129300015201100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-152-01) 2016-07-010000-00-00NoNoCurrent
29300-152-0529300015205500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-152-05) 2017-05-230000-00-00NoNoCurrent
29300-152-162930001521660 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-152-16) 2016-07-010000-00-00NoNoCurrent