FDA.reportPublic FDA data

DULOXETINE

Product NDC
61919-422
11-digit product format
619190422
Labeler code
61919
Product ID
61919-422_f2140162-b4c0-36f3-e053-2995a90a7956
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DULOXETINE
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Direct_Rx
Application
ANDA203088
Marketing category
ANDA
Marketing start
2019-08-19
Marketing end
0000-00-00
Substance
DULOXETINE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2024-12-31
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
61919-422-302025-01-30C16284748780-12cef2736-7086-d83d-e063-dadaa90ab31fDULOXETINE D/R
61919-422-602020-01-31C16284748780-19d75b9d0-7066-f424-e053-dadaa90a57ceDULOXETINE D/R

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-422-30DULOXETINE30 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS304
61919-422-60DULOXETINE60 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-422DULOXETINE CAPSULE, DELAYED RELEASE PELLETS [DIRECT_RX]4Legacy NDC, 1 package rows20230113_9078217c-16f4-a543-e053-2a95a90a31f2.zip
61919-422DULOXETINE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]1Legacy NDC, 1 package rows20161220_441a46f0-ecc7-4448-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN9078217c-16f4-a543-e053-2a95a90a31f24
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD9078217c-16f4-a543-e053-2a95a90a31f24
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY9078217c-16f4-a543-e053-2a95a90a31f24
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN441a46f0-ecc7-4448-e054-00144ff88e881
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD441a46f0-ecc7-4448-e054-00144ff88e881
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY441a46f0-ecc7-4448-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-422-306191904223030 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (61919-422-30) 2019-08-190000-00-00NoNoCurrent
61919-422-606191904226060 in 1 BOTTLEHistorical