FDA.reportPublic FDA data

Duloxetine

Product NDC
70518-1244
11-digit product format
705181244
Labeler code
70518
Product ID
70518-1244_5218b445-b416-afcf-e063-6294a90aefb6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090694
Marketing category
ANDA
Marketing start
2018-06-05
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
70518-1244-0Duloxetine30 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE3014
70518-1244-1Duloxetine60 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE6014
70518-1244-2Duloxetine180 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE18014
70518-1244-3Duloxetine30 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE3014
70518-1244-4Duloxetine50 in 1 BOXCAPSULE, DELAYED RELEASE5014
70518-1244-5Duloxetine1 in 1 POUCHCAPSULE, DELAYED RELEASE114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1244DULOXETINE CAPSULE, DELAYED RELEASE [REMEDYREPACK INC.]8Current NDC, Legacy NDC, 6 package rows20250509_461d769c-b787-4bc7-b4a6-7a5f33ae9d45.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596934DULoxetine 60 MG Delayed Release Oral CapsulePSN461d769c-b787-4bc7-b4a6-7a5f33ae9d4514
596934duloxetine 60 MG Delayed Release Oral CapsuleSCD461d769c-b787-4bc7-b4a6-7a5f33ae9d4514
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY461d769c-b787-4bc7-b4a6-7a5f33ae9d4514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-1244-07051812440030 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (70518-1244-0) 2018-06-05NoNoCurrent
70518-1244-17051812440160 in 1 BOTTLE, PLASTICHistorical
70518-1244-270518124402180 in 1 BOTTLE, PLASTICHistorical
70518-1244-37051812440330 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (70518-1244-3) 2025-12-09NoNoCurrent
70518-1244-47051812440450 POUCH in 1 BOX (70518-1244-4) / 1 CAPSULE, DELAYED RELEASE in 1 POUCH (70518-1244-5) 50 pouch2026-05-17NoNoCurrent
70518-1244-5705181244051 in 1 POUCHHistorical