FDA.reportPublic FDA data

Duloxetine

Product NDC
50436-0387
11-digit product format
504360387
Labeler code
50436
Product ID
50436-0387_088b8e35-794b-41fc-b793-e85c82328759
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA090739
Marketing category
ANDA
Marketing start
2014-05-27
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
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
50436-0387-12021-01-29C16284748780-1ba0f9c33-4b62-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use DULOXETINE delayed-release capsules, USP 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
50436-0387-1Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-0387-1EA - Each50436-03872de47e63-5207-40f1-ad3b-466c461c5d9f12017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0387DULOXETINE CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES]2Legacy NDC, 1 package rows20171010_b01e7880-3170-470f-9391-88bfe1f01511.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596934DULoxetine 60 MG Delayed Release Oral CapsulePSNb01e7880-3170-470f-9391-88bfe1f015112
596934duloxetine 60 MG Delayed Release Oral CapsuleSCDb01e7880-3170-470f-9391-88bfe1f015112
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSYb01e7880-3170-470f-9391-88bfe1f015112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0387-15043603870130 in 1 BOTTLEHistorical