FDA.reportPublic FDA data

Fluoxetine

Product NDC
50436-0726
11-digit product format
504360726
Labeler code
50436
Product ID
50436-0726_e635dc36-94c4-4ff5-a7fc-413246c8a707
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA204597
Marketing category
ANDA
Marketing start
2015-03-16
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50436-0726-12021-01-29C16284748780-1ba0f9c33-23ab-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use fluoxetine capsules, USP safely and effectively. See full prescribing information for fluoxetine capsules, USP. FLUOXETINE capsules, USP for oral use Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0726-1Fluoxetine30 in 1 BOTTLECAPSULE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0726FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [UNIT DOSE SERVICES]2Legacy NDC, 1 package rows20181010_519b443e-19ce-4dd6-aa7e-92a5733240aa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310385FLUoxetine 20 MG Oral CapsulePSN519b443e-19ce-4dd6-aa7e-92a5733240aa2
310385fluoxetine 20 MG Oral CapsuleSCD519b443e-19ce-4dd6-aa7e-92a5733240aa2
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY519b443e-19ce-4dd6-aa7e-92a5733240aa2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0726-15043607260130 in 1 BOTTLEHistorical