FDA.reportPublic FDA data

QUETIAPINE

Product NDC
43547-520
11-digit product format
435470520
Labeler code
43547
Product ID
43547-520_c91f8a6b-86e3-40a5-befe-4617aa36c718
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
quetiapine
Dosage form
TABLET
Route
ORAL
Labeler
Solco Healthcare US, LLC
Application
ANDA206954
Marketing category
ANDA
Marketing start
2022-04-12
Substance
QUETIAPINE FUMARATE
Active strength
100 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 FUMARATE100 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
21205abd-8c89-4943-9f85-908f3d4fc3bbProduct name520230501
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43547-520-10QUETIAPINE100 in 1 BOTTLETABLET1003
43547-520-11QUETIAPINE1000 in 1 BOTTLETABLET10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-520-10EA - Each43547-5209af5b2ff-4672-4a3f-97ab-7481c210b8fd12024-05-16
43547-520-11EA - Each43547-5208daa100f-0075-4648-82a3-fa2268f6ec7812024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-520QUETIAPINE TABLET [SOLCO HEALTHCARE US, LLC]2Current NDC, Legacy NDC, 2 package rows20240925_61b1230e-c0dc-46c6-a577-7d5dd2515eb7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312743QUEtiapine fumarate 100 MG Oral TabletPSN61b1230e-c0dc-46c6-a577-7d5dd2515eb73
317174QUEtiapine fumarate 200 MG Oral TabletPSN61b1230e-c0dc-46c6-a577-7d5dd2515eb73
312744QUEtiapine fumarate 25 MG Oral TabletPSN61b1230e-c0dc-46c6-a577-7d5dd2515eb73
312745QUEtiapine fumarate 300 MG Oral TabletPSN61b1230e-c0dc-46c6-a577-7d5dd2515eb73
616483QUEtiapine fumarate 400 MG Oral TabletPSN61b1230e-c0dc-46c6-a577-7d5dd2515eb73
616487QUEtiapine fumarate 50 MG Oral TabletPSN61b1230e-c0dc-46c6-a577-7d5dd2515eb73
312743quetiapine 100 MG Oral TabletSCD61b1230e-c0dc-46c6-a577-7d5dd2515eb73
317174quetiapine 200 MG Oral TabletSCD61b1230e-c0dc-46c6-a577-7d5dd2515eb73
312744quetiapine 25 MG Oral TabletSCD61b1230e-c0dc-46c6-a577-7d5dd2515eb73
312745quetiapine 300 MG Oral TabletSCD61b1230e-c0dc-46c6-a577-7d5dd2515eb73
616483quetiapine 400 MG Oral TabletSCD61b1230e-c0dc-46c6-a577-7d5dd2515eb73
616487quetiapine 50 MG Oral TabletSCD61b1230e-c0dc-46c6-a577-7d5dd2515eb73
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY61b1230e-c0dc-46c6-a577-7d5dd2515eb73
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSY61b1230e-c0dc-46c6-a577-7d5dd2515eb73
312744quetiapine (as quetiapine fumarate) 25 MG Oral TabletSY61b1230e-c0dc-46c6-a577-7d5dd2515eb73
312745quetiapine (as quetiapine fumarate) 300 MG Oral TabletSY61b1230e-c0dc-46c6-a577-7d5dd2515eb73
616483quetiapine (as quetiapine fumarate) 400 MG Oral TabletSY61b1230e-c0dc-46c6-a577-7d5dd2515eb73
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSY61b1230e-c0dc-46c6-a577-7d5dd2515eb73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43547-520-1043547052010100 TABLET in 1 BOTTLE (43547-520-10) 100 tablet2022-04-120000-00-00NoNoCurrent
43547-520-11435470520111000 TABLET in 1 BOTTLE (43547-520-11) 1000 tablet2022-04-120000-00-00NoNoCurrent