FDA.reportPublic FDA data

Duloxetine

Product NDC
70518-1011
11-digit product format
705181011
Labeler code
70518
Product ID
70518-1011_4849b7fd-a904-8fde-e063-6394a90a1f0f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA208706
Marketing category
ANDA
Marketing start
2018-02-12
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
70518-1011-0Duloxetine30 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE3019
70518-1011-1Duloxetine30 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE3019
70518-1011-2Duloxetine60 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE6019

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1011DULOXETINE CAPSULE, DELAYED RELEASE [REMEDYREPACK INC.]15Current NDC, Legacy NDC, 3 package rows20250510_ba4adb77-45be-4310-a877-766692f22e5e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596934DULoxetine 60 MG Delayed Release Oral CapsulePSNba4adb77-45be-4310-a877-766692f22e5e19
596934duloxetine 60 MG Delayed Release Oral CapsuleSCDba4adb77-45be-4310-a877-766692f22e5e19
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSYba4adb77-45be-4310-a877-766692f22e5e19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-1011-07051810110030 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (70518-1011-0) 2018-02-120000-00-00NoNoCurrent
70518-1011-17051810110130 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-1011-1) 2019-04-170000-00-00NoNoCurrent
70518-1011-27051810110260 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-1011-2) 2020-05-040000-00-00NoNoCurrent