FDA.reportPublic FDA data

DULOXETINE DELAYED-RELEASE

Product NDC
53217-130
11-digit product format
532170130
Labeler code
53217
Product ID
53217-130_6483fe74-0165-4b79-b14c-ae4881728118
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DULOXETINE HYDROCHLORIDE
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA203088
Marketing category
ANDA
Marketing start
2014-06-11
Marketing end
0000-00-00
Substance
DULOXETINE HYDROCHLORIDE
Active strength
60 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
2019-12-31
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
53217-130-302020-01-31C16284748780-19d75b9d0-82f3-f424-e053-dadaa90a57ceThese 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 USP for oral use. Initial U.S. Approval: 2004
53217-130-602020-01-31C16284748780-19d75b9d0-82f3-f424-e053-dadaa90a57ceThese 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 USP for oral use. Initial U.S. Approval: 2004
53217-130-902020-01-31C16284748780-19d75b9d0-82f3-f424-e053-dadaa90a57ceThese 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 USP for oral use. Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-130-30DULOXETINE DELAYED-RELEASEDELAYED-RELEASE30 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS301
53217-130-60DULOXETINE DELAYED-RELEASEDELAYED-RELEASE60 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS601
53217-130-90DULOXETINE DELAYED-RELEASEDELAYED-RELEASE90 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-130DULOXETINE DELAYED-RELEASE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 3 package rows20170422_776f73e2-b8b8-47b1-8b3b-03fa77cffee2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596934DULoxetine 60 MG Delayed Release Oral CapsulePSN776f73e2-b8b8-47b1-8b3b-03fa77cffee21
596934duloxetine 60 MG Delayed Release Oral CapsuleSCD776f73e2-b8b8-47b1-8b3b-03fa77cffee21
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY776f73e2-b8b8-47b1-8b3b-03fa77cffee21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-130-305321701303030 in 1 BOTTLEHistorical
53217-130-605321701306060 in 1 BOTTLEHistorical
53217-130-905321701309090 in 1 BOTTLEHistorical