FDA.reportPublic FDA data

Duloxetine

Product NDC
50090-4709
11-digit product format
500904709
Labeler code
50090
Product ID
50090-4709_aef439c1-1e95-4235-8f46-55991f4db3d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204343
Marketing category
ANDA
Marketing start
2016-08-11
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
aebfdb62-b550-4c4f-9225-d5d3bbc7ab88Product name920210727
7dd29e28-6b69-499b-9257-12a3b46ca283Product name120191120
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4709-02023-01-30C16284748780-1f386c649-ed2a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DULOXETINE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for DULOXETINE DELAYED-RELEASE CAPSULES. DULOXETINE delayed-release capsules, for Oral Use. Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4709-0Duloxetine44 in 1 BOTTLECAPSULE, DELAYED RELEASE441

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4709DULOXETINE CAPSULE, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]1Legacy NDC, 1 package rows20210115_0500c320-2954-46a0-9437-091753f56bab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN0500c320-2954-46a0-9437-091753f56bab1
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD0500c320-2954-46a0-9437-091753f56bab1
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY0500c320-2954-46a0-9437-091753f56bab1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4709-05009047090044 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-4709-0) 2019-11-110000-00-00NoNoCurrent