FDA.reportPublic FDA data

Duloxetine

Product NDC
50436-2892
11-digit product format
504362892
Labeler code
50436
Product ID
50436-2892_4d2a8baf-f63d-466f-aac1-4df63c965245
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA090776
Marketing category
ANDA
Marketing start
2013-12-17
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
50436-2892-12020-01-31C16284748780-19d75b9d0-f2b9-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
50436-2892-1Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-2892-1EA - Each50436-2892c131384d-5f9b-43c4-b01f-7c7562870c4312017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-2892DULOXETINE CAPSULE, DELAYED RELEASE PELLETS [UNIT DOSE SERVICES]3Legacy NDC, 1 package rows20171201_42c2fa9a-fe8f-46dd-93b3-3784a3c62d36.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596934DULoxetine 60 MG Delayed Release Oral CapsulePSN42c2fa9a-fe8f-46dd-93b3-3784a3c62d363
596934duloxetine 60 MG Delayed Release Oral CapsuleSCD42c2fa9a-fe8f-46dd-93b3-3784a3c62d363
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY42c2fa9a-fe8f-46dd-93b3-3784a3c62d363

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-2892-15043628920130 in 1 BOTTLEHistorical