FLUOXETINE

Product NDC
61919-253
11-digit product format
619190253
Labeler code
61919
Product ID
61919-253_9c9424d4-424c-110f-e053-2995a90ac6c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLUOXETINE
Dosage form
CAPSULE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA090223
Marketing category
ANDA
Marketing start
2017-10-30
Marketing end
0000-00-00
Substance
FLUOXETINE HYDROCHLORIDE
Active strength
40 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
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
61919-253-302023-01-30C16284748780-1f386c64a-0730-0266-e053-dadaa90a7c1aFLUOXETINE 40mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-253-30FLUOXETINE30 in 1 BOTTLECAPSULE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-253FLUOXETINE CAPSULE [DIRECT RX]2Legacy NDC, 1 package rows20200121_5cccc071-9aa0-2995-e053-2991aa0a7f9a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313989FLUoxetine 40 MG Oral CapsulePSN5cccc071-9aa0-2995-e053-2991aa0a7f9a2
313989fluoxetine 40 MG Oral CapsuleSCD5cccc071-9aa0-2995-e053-2991aa0a7f9a2
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY5cccc071-9aa0-2995-e053-2991aa0a7f9a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-253-306191902533030 CAPSULE in 1 BOTTLE (61919-253-30) 30 capsule2017-10-300000-00-00NoNoCurrent