FDA.reportPublic FDA data

Duloxetine

Product NDC
45865-815
11-digit product format
458650815
Labeler code
45865
Product ID
45865-815_7dc9638a-dbbb-c190-e053-2a91aa0a1be9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DULOXETINE HYDROCHLORIDE
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
medsource pharmaceuticals
Application
ANDA203088
Marketing category
ANDA
Marketing start
2014-06-11
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
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
45865-815-302025-01-30C16284748780-12cef2736-8ea8-d83d-e063-dadaa90ab31fThese 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
45865-815-602025-01-30C16284748780-12cef2736-8ea8-d83d-e063-dadaa90ab31fThese 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
45865-815-30DuloxetineDelayed-Release30 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS301
45865-815-60DuloxetineDelayed-Release60 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-815DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 2 package rows20181225_7dc9638a-dbba-c190-e053-2a91aa0a1be9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN7dc9638a-dbba-c190-e053-2a91aa0a1be91
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD7dc9638a-dbba-c190-e053-2a91aa0a1be91
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY7dc9638a-dbba-c190-e053-2a91aa0a1be91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45865-815-304586508153030 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (45865-815-30) 2018-06-010000-00-00NoNoCurrent
45865-815-604586508156060 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (45865-815-60) 2018-06-010000-00-00NoNoCurrent