FDA.reportPublic FDA data

Duloxetine

Product NDC
70518-2630
11-digit product format
705182630
Labeler code
70518
Product ID
70518-2630_4e7ae363-8618-210e-e063-6294a90a8333
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA208706
Marketing category
ANDA
Marketing start
2020-03-16
Substance
DULOXETINE HYDROCHLORIDE
Active strength
60 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Duloxetine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DULOXETINE HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9044SC542W
Rxcui596934

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
aebfdb62-b550-4c4f-9225-d5d3bbc7ab88Product name920210727
7dd29e28-6b69-499b-9257-12a3b46ca283Product name120191120

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2630-0Duloxetine60 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE6015
70518-2630-1Duloxetine30 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE3015
70518-2630-2Duloxetine90 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE9015
70518-2630-3Duloxetine180 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE18015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2630DULOXETINE CAPSULE, DELAYED RELEASE [REMEDYREPACK INC.]11Current NDC, Legacy NDC, 4 package rows20250524_ac903bda-76af-4aba-9c8a-ebf7066e05ee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596934DULoxetine 60 MG Delayed Release Oral CapsulePSNac903bda-76af-4aba-9c8a-ebf7066e05ee15
596934duloxetine 60 MG Delayed Release Oral CapsuleSCDac903bda-76af-4aba-9c8a-ebf7066e05ee15
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSYac903bda-76af-4aba-9c8a-ebf7066e05ee15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2630-07051826300060 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-2630-0) 2020-03-160000-00-00NoNoCurrent
70518-2630-17051826300130 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-2630-1) 2020-04-130000-00-00NoNoCurrent
70518-2630-27051826300290 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-2630-2) 2020-07-280000-00-00NoNoCurrent
70518-2630-370518263003180 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-2630-3) 2025-10-09NoNoHistorical