Fluoxetine

Product NDC
50436-1930
11-digit product format
504361930
Labeler code
50436
Product ID
50436-1930_6adc2341-dddd-4769-b7fc-dbf9af6d9eef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA078619
Marketing category
ANDA
Marketing start
2008-01-31
Marketing end
0000-00-00
Substance
FLUOXETINE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
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
50436-1930-1Fluoxetine30 in 1 BOTTLECAPSULE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-1930FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [UNIT DOSE SERVICES]2Legacy NDC, 1 package rows20190921_306a045b-9671-4133-b042-3adc617efb93.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310385FLUoxetine 20 MG Oral CapsulePSN306a045b-9671-4133-b042-3adc617efb932
310385fluoxetine 20 MG Oral CapsuleSCD306a045b-9671-4133-b042-3adc617efb932
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY306a045b-9671-4133-b042-3adc617efb932

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-1930-15043619300130 in 1 BOTTLEHistorical