FDA.reportPublic FDA data

Quetiapine fumarate

Product NDC
68788-8778
11-digit product format
687888778
Labeler code
68788
Product ID
68788-8778_25bd0504-bb8c-460d-a675-555173b53820
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
quetiapine fumarate
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA201109
Marketing category
ANDA
Marketing start
2024-12-10
Substance
QUETIAPINE FUMARATE
Active strength
50 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 FUMARATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S3PL1B6UJ
Rxcui616487

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
68788-8778-1Quetiapine fumarate100 in 1 BOTTLETABLET1002
68788-8778-3Quetiapine fumarate30 in 1 BOTTLETABLET302
68788-8778-6Quetiapine fumarate60 in 1 BOTTLETABLET602
68788-8778-8Quetiapine fumarate120 in 1 BOTTLETABLET1202
68788-8778-9Quetiapine fumarate90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8778-1EA - Each68788-87789cc60dfa-7ea8-4106-8de6-1c0ab32b758012025-01-14
68788-8778-3EA - Each68788-877846438460-94c3-4b8d-866d-93fe2a01566b12025-01-14
68788-8778-6EA - Each68788-8778f5e94055-8827-4ef3-9198-cb3f65ef788612025-01-14
68788-8778-8EA - Each68788-8778291832b7-4381-4dd6-8f07-a682a76e0b6712025-01-14
68788-8778-9EA - Each68788-87783ee7d6ce-b290-44f5-a238-53005599baa712025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8778QUETIAPINE FUMARATE TABLET [PREFERRED PHARMACEUTICALS, INC.]1Current NDC, 5 package rows20241212_1fe839fa-c566-4374-997f-f5b9d97b5fb8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616487QUEtiapine fumarate 50 MG Oral TabletPSN1fe839fa-c566-4374-997f-f5b9d97b5fb82
616487quetiapine 50 MG Oral TabletSCD1fe839fa-c566-4374-997f-f5b9d97b5fb82
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSY1fe839fa-c566-4374-997f-f5b9d97b5fb82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8778-168788877801100 TABLET in 1 BOTTLE (68788-8778-1) 100 tablet2024-12-10NoNoHistorical
68788-8778-36878887780330 TABLET in 1 BOTTLE (68788-8778-3) 30 tablet2024-12-10NoNoHistorical
68788-8778-66878887780660 TABLET in 1 BOTTLE (68788-8778-6) 60 tablet2024-12-10NoNoHistorical
68788-8778-868788877808120 TABLET in 1 BOTTLE (68788-8778-8) 120 tablet2024-12-10NoNoHistorical
68788-8778-96878887780990 TABLET in 1 BOTTLE (68788-8778-9) 90 tablet2024-12-10NoNoHistorical