Fluoxetine

Product NDC
58118-0645
11-digit product format
581180645
Labeler code
58118
Product ID
58118-0645_ebc84746-7766-38a8-e053-2995a90ae36a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Clinical Solutions Wholesale, LLC
Application
ANDA076001
Marketing category
ANDA
Marketing start
2002-01-29
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
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58118-0645-82024-01-30C16284748780-11030e365-3bd1-111a-e063-dadaa90a10e2667b3af5-103b-462f-a5a6-bab599662c13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58118-0645FLUOXETINE CAPSULE [CLINICAL SOLUTIONS WHOLESALE, LLC]8Legacy NDC20221027_667b3af5-103b-462f-a5a6-bab599662c13.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58118-0645-85811806450830 CAPSULE in 1 BLISTER PACK (58118-0645-8) 30 capsule2016-06-230000-00-00NoNoCurrent