FDA.reportPublic FDA data

Duloxetine

Product NDC
50090-4011
11-digit product format
500904011
Labeler code
50090
Product ID
50090-4011_c11744b8-64d3-4096-8c08-f6d2246c70ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090739
Marketing category
ANDA
Marketing start
2014-05-27
Marketing end
0000-00-00
Substance
DULOXETINE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine 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
aebfdb62-b550-4c4f-9225-d5d3bbc7ab88Product name920210727
7dd29e28-6b69-499b-9257-12a3b46ca283Product name120191120

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4011-02023-01-30C16284748780-1f386c649-fd7b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DULOXETINE delayed-release capsules, USP safely and effectively. See full prescribing information for DULOXETINE. DULOXETINE delayed-release capsules USP, for oral use. Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4011-0Duloxetine44 in 1 BOTTLECAPSULE, DELAYED RELEASE441

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4011DULOXETINE CAPSULE, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]1Legacy NDC, 1 package rows20190118_7020f4cd-4e10-4334-8eb0-ea35d984aba9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN7020f4cd-4e10-4334-8eb0-ea35d984aba91
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD7020f4cd-4e10-4334-8eb0-ea35d984aba91
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY7020f4cd-4e10-4334-8eb0-ea35d984aba91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4011-05009040110044 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-4011-0) 2018-12-310000-00-00NoNoCurrent