FDA.reportPublic FDA data

Quetiapine Fumarate

Product NDC
68788-8859
11-digit product format
687888859
Labeler code
68788
Product ID
68788-8859_951a098a-d905-4723-89e1-71bf1551dcb6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine Fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA091388
Marketing category
ANDA
Marketing start
2025-04-11
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
Rxcui317174

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
68788-8859-1Quetiapine Fumarate100 in 1 BOTTLETABLET, FILM COATED1001
68788-8859-3Quetiapine Fumarate30 in 1 BOTTLETABLET, FILM COATED301
68788-8859-6Quetiapine Fumarate60 in 1 BOTTLETABLET, FILM COATED601
68788-8859-8Quetiapine Fumarate120 in 1 BOTTLETABLET, FILM COATED1201
68788-8859-9Quetiapine Fumarate90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8859-1EA - Each68788-8859176b4b55-b283-43b0-9ac2-d46c9d5a495712025-07-08
68788-8859-3EA - Each68788-88596e787756-b8e8-464a-a3f2-698777e9ff4412025-07-08
68788-8859-6EA - Each68788-8859c19373c7-8100-4ccb-8c41-e3896b22cdcc12025-07-08
68788-8859-8EA - Each68788-885926c4eca7-b0ac-44d5-95e7-a0a356d50dd612025-07-08
68788-8859-9EA - Each68788-88597b2e1062-4c9a-4fa6-ad20-4b2ce2578e2112025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8859QUETIAPINE FUMARATE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 5 package rows20250413_951a098a-d905-4723-89e1-71bf1551dcb6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317174QUEtiapine fumarate 200 MG Oral TabletPSN951a098a-d905-4723-89e1-71bf1551dcb61
317174quetiapine 200 MG Oral TabletSCD951a098a-d905-4723-89e1-71bf1551dcb61
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSY951a098a-d905-4723-89e1-71bf1551dcb61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8859-168788885901100 TABLET, FILM COATED in 1 BOTTLE (68788-8859-1) 2025-04-11NoNoHistorical
68788-8859-36878888590330 TABLET, FILM COATED in 1 BOTTLE (68788-8859-3) 2025-04-11NoNoHistorical
68788-8859-66878888590660 TABLET, FILM COATED in 1 BOTTLE (68788-8859-6) 2025-04-11NoNoHistorical
68788-8859-868788885908120 TABLET, FILM COATED in 1 BOTTLE (68788-8859-8) 2025-04-11NoNoHistorical
68788-8859-96878888590990 TABLET, FILM COATED in 1 BOTTLE (68788-8859-9) 2025-04-11NoNoHistorical