FDA.reportPublic FDA data

Duloxetine

Product NDC
45865-813
11-digit product format
458650813
Labeler code
45865
Product ID
45865-813_9ab40f3c-d695-e12a-e053-2995a90a2b3e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA090723
Marketing category
ANDA
Marketing start
2014-06-18
Marketing end
0000-00-00
Substance
DULOXETINE HYDROCHLORIDE
Active strength
30 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
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45865-813-302025-01-31C16284748780-1f386c649-a4dc-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use duloxetine safely and effectively. See full prescribing information for duloxetine . DULOXETINE delayed-release capsules USP for oral use. Initial U.S. Approval: 2004
45865-813-602025-01-31C16284748780-1f386c649-a4dc-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use duloxetine 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
45865-813-30Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS302
45865-813-60Duloxetine60 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-813DULOXETINE CAPSULE, DELAYED RELEASE PELLETS [MEDSOURCE PHARMACEUTICALS]2Legacy NDC, 2 package rows20191228_2084fc8f-b9f9-65e2-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN2084fc8f-b9f9-65e2-e054-00144ff8d46c2
596934DULoxetine 60 MG Delayed Release Oral CapsulePSN2084fc8f-b9f9-65e2-e054-00144ff8d46c2
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD2084fc8f-b9f9-65e2-e054-00144ff8d46c2
596934duloxetine 60 MG Delayed Release Oral CapsuleSCD2084fc8f-b9f9-65e2-e054-00144ff8d46c2
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY2084fc8f-b9f9-65e2-e054-00144ff8d46c2
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY2084fc8f-b9f9-65e2-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45865-813-304586508133030 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (45865-813-30) 2015-09-220000-00-00NoNoCurrent
45865-813-604586508136060 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (45865-813-60) 2015-09-220000-00-00NoNoCurrent