FLUOXETINE

Product NDC
61919-745
11-digit product format
619190745
Labeler code
61919
Product ID
61919-745_8fa00971-6d51-2d88-e053-2a95a90aed6a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLUOXETINE
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA204597
Marketing category
ANDA
Marketing start
2019-08-08
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
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
61919-745-302023-01-30C16284748780-1f386c64a-1c49-0266-e053-dadaa90a7c1aFLUOXETINE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-745-30FLUOXETINE30 in 1 BOTTLECAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-745FLUOXETINE CAPSULE [DIRECT_RX]1Legacy NDC, 1 package rows20190809_8fa00971-6d50-2d88-e053-2a95a90aed6a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313989FLUoxetine 40 MG Oral CapsulePSN8fa00971-6d50-2d88-e053-2a95a90aed6a1
313989fluoxetine 40 MG Oral CapsuleSCD8fa00971-6d50-2d88-e053-2a95a90aed6a1
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY8fa00971-6d50-2d88-e053-2a95a90aed6a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-745-306191907453030 CAPSULE in 1 BOTTLE (61919-745-30) 30 capsule2019-08-080000-00-00NoNoCurrent