Fluoxetine

Product NDC
50090-6066
11-digit product format
500906066
Labeler code
50090
Product ID
50090-6066_9853c9a4-1176-4ff0-b03e-19f2924fd093
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078619
Marketing category
ANDA
Marketing start
2008-01-31
Marketing end
0000-00-00
Substance
FLUOXETINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce7d40ce-bfb8-ee15-a060-423ec90d7ac9Product name620250331
e5b459e3-ddce-4802-aab4-2c901d71ae85Product name520250129
6d3d5b3a-d6b8-8417-8428-6414b08f1464Product name320240130
e7177a8f-11de-ee90-ca22-068e6ef54cf5Product name420230104
82da1192-6e97-fa73-2f85-6a50c10b4704Product name320161212
877783eb-030c-6e3f-0979-804cf94d8856Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6066-0Fluoxetine1 in 1 CARTONCAPSULE11
50090-6066-0Fluoxetine32 in 1 BLISTER PACKCAPSULE321

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6066FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [A-S MEDICATION SOLUTIONS]1Legacy NDC, 2 package rows20220919_f54fa907-b1f5-4c11-9e1e-471998c07df2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310384FLUoxetine 10 MG Oral CapsulePSNf54fa907-b1f5-4c11-9e1e-471998c07df21
310384fluoxetine 10 MG Oral CapsuleSCDf54fa907-b1f5-4c11-9e1e-471998c07df21
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSYf54fa907-b1f5-4c11-9e1e-471998c07df21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-6066-0500906066001 BLISTER PACK in 1 CARTON (50090-6066-0) > 32 CAPSULE in 1 BLISTER PACK1 blister pack2022-09-090000-00-00NoNoCurrent