FDA.reportPublic FDA data

Duloxetine

Product NDC
50090-2585
11-digit product format
500902585
Labeler code
50090
Product ID
50090-2585_e0f9b29e-b2af-45fa-a5b6-8b13cd822ecc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine Hydrochloride
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090778
Marketing category
ANDA
Marketing start
2013-12-11
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
2022-12-31
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
50090-2585-02023-01-30C16284748780-1f386c64a-0431-0266-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
50090-2585-12023-01-30C16284748780-1f386c64a-0431-0266-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
50090-2585-0Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE3019
50090-2585-1Duloxetine90 in 1 BOTTLECAPSULE, DELAYED RELEASE9019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2585-0EA - Each50090-25850930e0cf-24bb-4e04-b1f2-115a741db3fe12019-04-11
50090-2585-1EA - Each50090-258509c81f08-ed0d-46b8-84b6-2b9b0804f12d12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2585DULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]19Legacy NDC, 2 package rows20210302_8dd64d72-4219-4e38-9855-e9b5190bbd30.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596934DULoxetine 60 MG Delayed Release Oral CapsulePSN8dd64d72-4219-4e38-9855-e9b5190bbd3019
596934duloxetine 60 MG Delayed Release Oral CapsuleSCD8dd64d72-4219-4e38-9855-e9b5190bbd3019
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY8dd64d72-4219-4e38-9855-e9b5190bbd3019

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-2585-05009025850030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-2585-0) 2016-11-020000-00-00NoNoCurrent
50090-2585-15009025850190 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-2585-1) 2016-11-180000-00-00NoNoCurrent