FDA.reportPublic FDA data

Duloxetine

Product NDC
50090-2844
11-digit product format
500902844
Labeler code
50090
Product ID
50090-2844_ea650db2-0f4b-40f7-971a-7b7aefcd97f2
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
50090-2844-02023-01-30C16284748780-19d75b9d0-c3b5-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, for oral use Initial U.S. Approval: 2004
50090-2844-02020-02-17C16284748780-19d75b9d0-c3b5-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, for oral use Initial U.S. Approval: 2004
50090-2844-02020-01-31C16284748780-19d75b9d0-c3b5-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, for oral use Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2844-0Duloxetine29 in 1 BOX, UNIT-DOSECAPSULE, DELAYED RELEASE2916
50090-2844-0Duloxetine1 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2844-0EA - Each50090-2844c7241893-b244-40b5-9a33-032d9df717c312019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2844DULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]16Legacy NDC, 2 package rows20210302_a8d16ade-6a05-4010-9c21-d1840a4d4fc7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596934DULoxetine 60 MG Delayed Release Oral CapsulePSNa8d16ade-6a05-4010-9c21-d1840a4d4fc716
596934duloxetine 60 MG Delayed Release Oral CapsuleSCDa8d16ade-6a05-4010-9c21-d1840a4d4fc716
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSYa8d16ade-6a05-4010-9c21-d1840a4d4fc716

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2844-05009028440029 BLISTER PACK in 1 BOX, UNIT-DOSE (50090-2844-0) > 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK29 blister pack2017-02-080000-00-00NoNoCurrent