FDA.reportPublic FDA data

Quetiapine fumarate

Product NDC
68788-8764
11-digit product format
687888764
Labeler code
68788
Product ID
68788-8764_6621210b-edd5-46f6-aa72-f4befa35bccc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
quetiapine fumarate
Dosage form
TABLET
Route
ORAL
Labeler
: Preferred Pharmaceuticals Inc.
Application
ANDA201109
Marketing category
ANDA
Marketing start
2024-11-11
Substance
QUETIAPINE FUMARATE
Active strength
25 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Quetiapine fumarate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
QUETIAPINE FUMARATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S3PL1B6UJ
Rxcui312744

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
68788-8764-1Quetiapine fumarate100 in 1 BOTTLETABLET1002
68788-8764-3Quetiapine fumarate30 in 1 BOTTLETABLET302
68788-8764-6Quetiapine fumarate60 in 1 BOTTLETABLET602
68788-8764-8Quetiapine fumarate120 in 1 BOTTLETABLET1202
68788-8764-9Quetiapine fumarate90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8764-1EA - Each68788-87648e92d49d-2297-4547-abb0-61da93ca66c712025-01-14
68788-8764-3EA - Each68788-8764f9ba253c-daa7-479e-a408-cf66c9369b8d12025-01-14
68788-8764-6EA - Each68788-87648b3afde4-8b6b-4eab-9843-383687efe27112025-01-14
68788-8764-8EA - Each68788-87641ac9c3a5-ca86-4c72-970d-838d2fd96fc112025-01-14
68788-8764-9EA - Each68788-87643e2b438a-81b4-4986-861b-99a6e5329d6012025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8764QUETIAPINE FUMARATE TABLET [: PREFERRED PHARMACEUTICALS INC.]1Current NDC, 5 package rows20241113_f3c91d05-038b-40f4-8c1f-2910773ec567.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312744QUEtiapine fumarate 25 MG Oral TabletPSNf3c91d05-038b-40f4-8c1f-2910773ec5672
312744quetiapine 25 MG Oral TabletSCDf3c91d05-038b-40f4-8c1f-2910773ec5672
312744quetiapine (as quetiapine fumarate) 25 MG Oral TabletSYf3c91d05-038b-40f4-8c1f-2910773ec5672

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8764-168788876401100 TABLET in 1 BOTTLE (68788-8764-1) 100 tablet2024-11-11NoNoHistorical
68788-8764-36878887640330 TABLET in 1 BOTTLE (68788-8764-3) 30 tablet2024-11-11NoNoHistorical
68788-8764-66878887640660 TABLET in 1 BOTTLE (68788-8764-6) 60 tablet2024-11-11NoNoHistorical
68788-8764-868788876408120 TABLET in 1 BOTTLE (68788-8764-8) 120 tablet2024-11-11NoNoHistorical
68788-8764-96878887640990 TABLET in 1 BOTTLE (68788-8764-9) 90 tablet2024-11-11NoNoHistorical