FDA.reportPublic FDA data

Quetiapine Fumarate

Product NDC
51407-069
11-digit product format
514070069
Labeler code
51407
Product ID
51407-069_31e6a4fb-7f18-d5a4-e063-6394a90acfb3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine Fumarate
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA090749
Marketing category
ANDA
Marketing start
2012-03-27
Substance
QUETIAPINE FUMARATE
Active strength
200 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 FUMARATE200 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
51407-069-01Quetiapine Fumarate100 in 1 BOTTLETABLET10011
51407-069-05Quetiapine Fumarate500 in 1 BOTTLETABLET50011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-069-01EA - Each51407-0692b3f5d56-2f4e-45ff-872a-7992cd057a8e12018-08-13
51407-069-05EA - Each51407-0691b6ac758-c410-4d8f-8dcc-78030e253a4d12019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-069QUETIAPINE FUMARATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]11Current NDC, Legacy NDC, 2 package rows20250406_6fc9c8e2-6f34-aa43-e053-2a91aa0ac377.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312743QUEtiapine fumarate 100 MG Oral TabletPSN6fc9c8e2-6f34-aa43-e053-2a91aa0ac37711
317174QUEtiapine fumarate 200 MG Oral TabletPSN6fc9c8e2-6f34-aa43-e053-2a91aa0ac37711
312744QUEtiapine fumarate 25 MG Oral TabletPSN6fc9c8e2-6f34-aa43-e053-2a91aa0ac37711
312745QUEtiapine fumarate 300 MG Oral TabletPSN6fc9c8e2-6f34-aa43-e053-2a91aa0ac37711
616483QUEtiapine fumarate 400 MG Oral TabletPSN6fc9c8e2-6f34-aa43-e053-2a91aa0ac37711
616487QUEtiapine fumarate 50 MG Oral TabletPSN6fc9c8e2-6f34-aa43-e053-2a91aa0ac37711
312743quetiapine 100 MG Oral TabletSCD6fc9c8e2-6f34-aa43-e053-2a91aa0ac37711
317174quetiapine 200 MG Oral TabletSCD6fc9c8e2-6f34-aa43-e053-2a91aa0ac37711
312744quetiapine 25 MG Oral TabletSCD6fc9c8e2-6f34-aa43-e053-2a91aa0ac37711
312745quetiapine 300 MG Oral TabletSCD6fc9c8e2-6f34-aa43-e053-2a91aa0ac37711
616483quetiapine 400 MG Oral TabletSCD6fc9c8e2-6f34-aa43-e053-2a91aa0ac37711
616487quetiapine 50 MG Oral TabletSCD6fc9c8e2-6f34-aa43-e053-2a91aa0ac37711
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY6fc9c8e2-6f34-aa43-e053-2a91aa0ac37711
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSY6fc9c8e2-6f34-aa43-e053-2a91aa0ac37711
312744quetiapine (as quetiapine fumarate) 25 MG Oral TabletSY6fc9c8e2-6f34-aa43-e053-2a91aa0ac37711
312745quetiapine (as quetiapine fumarate) 300 MG Oral TabletSY6fc9c8e2-6f34-aa43-e053-2a91aa0ac37711
616483quetiapine (as quetiapine fumarate) 400 MG Oral TabletSY6fc9c8e2-6f34-aa43-e053-2a91aa0ac37711
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSY6fc9c8e2-6f34-aa43-e053-2a91aa0ac37711
312743QUEtiapine fumarate 100 MG Oral TabletPSN60316ccd-c042-4ea0-9d05-3caf7cc2cab12
317174QUEtiapine fumarate 200 MG Oral TabletPSN60316ccd-c042-4ea0-9d05-3caf7cc2cab12
312744QUEtiapine fumarate 25 MG Oral TabletPSN60316ccd-c042-4ea0-9d05-3caf7cc2cab12
312745QUEtiapine fumarate 300 MG Oral TabletPSN60316ccd-c042-4ea0-9d05-3caf7cc2cab12
616483QUEtiapine fumarate 400 MG Oral TabletPSN60316ccd-c042-4ea0-9d05-3caf7cc2cab12
312743quetiapine 100 MG Oral TabletSCD60316ccd-c042-4ea0-9d05-3caf7cc2cab12
317174quetiapine 200 MG Oral TabletSCD60316ccd-c042-4ea0-9d05-3caf7cc2cab12
312744quetiapine 25 MG Oral TabletSCD60316ccd-c042-4ea0-9d05-3caf7cc2cab12
312745quetiapine 300 MG Oral TabletSCD60316ccd-c042-4ea0-9d05-3caf7cc2cab12
616483quetiapine 400 MG Oral TabletSCD60316ccd-c042-4ea0-9d05-3caf7cc2cab12
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY60316ccd-c042-4ea0-9d05-3caf7cc2cab12
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSY60316ccd-c042-4ea0-9d05-3caf7cc2cab12
312744quetiapine (as quetiapine fumarate) 25 MG Oral TabletSY60316ccd-c042-4ea0-9d05-3caf7cc2cab12
312745quetiapine (as quetiapine fumarate) 300 MG Oral TabletSY60316ccd-c042-4ea0-9d05-3caf7cc2cab12
616483quetiapine (as quetiapine fumarate) 400 MG Oral TabletSY60316ccd-c042-4ea0-9d05-3caf7cc2cab12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51407-069-0151407006901100 TABLET in 1 BOTTLE (51407-069-01) 100 tablet2018-03-260000-00-00NoNoCurrent
51407-069-0551407006905500 TABLET in 1 BOTTLE (51407-069-05) 500 tablet2018-10-300000-00-00NoNoCurrent