DULOXETINE

Product NDC
61919-636
11-digit product format
619190636
Labeler code
61919
Product ID
61919-636_49107644-9ba4-31b9-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DULOXETINE
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA090745
Marketing category
ANDA
Marketing start
2017-02-20
Marketing end
0000-00-00
Substance
DULOXETINE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
aebfdb62-b550-4c4f-9225-d5d3bbc7ab88Product name920210727
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
7dd29e28-6b69-499b-9257-12a3b46ca283Product name120191120
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-636-202020-01-31C16284748780-19d75b9cf-fd91-f424-e053-dadaa90a57ceDULOXETINE
61919-636-602020-01-31C16284748780-19d75b9cf-fd91-f424-e053-dadaa90a57ceDULOXETINE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-636-20DULOXETINE20 in 1 BOTTLECAPSULE, DELAYED RELEASE202
61919-636-60DULOXETINE60 in 1 BOTTLECAPSULE, DELAYED RELEASE602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-636-20EA - Each61919-636d16c3ee6-629c-44cc-bb11-3a246f109c5b12017-03-06
61919-636-60EA - Each61919-6360cb9d7d6-fe31-42bf-85b4-fe759cf3a96b12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-636DULOXETINE CAPSULE, DELAYED RELEASE [DIRECT RX]2Legacy NDC, 2 package rows20170221_48fb3410-bb87-42ce-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN48fb3410-bb87-42ce-e054-00144ff88e882
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD48fb3410-bb87-42ce-e054-00144ff88e882
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY48fb3410-bb87-42ce-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-636-206191906362020 in 1 BOTTLEHistorical
61919-636-606191906366060 in 1 BOTTLEHistorical