FDA.reportPublic FDA data

Duloxetine

Product NDC
70518-1139
11-digit product format
705181139
Labeler code
70518
Product ID
70518-1139_485b3c93-6f32-6ee9-e063-6294a90a13a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA208706
Marketing category
ANDA
Marketing start
2018-04-25
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
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 HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9044SC542W
Rxcui596926

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
70518-1139-0Duloxetine30 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE3021
70518-1139-1Duloxetine60 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE6021
70518-1139-2Duloxetine180 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE18021
70518-1139-3Duloxetine30 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE3021
70518-1139-4Duloxetine30 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE3021

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1139DULOXETINE CAPSULE, DELAYED RELEASE [REMEDYREPACK INC.]15Current NDC, Legacy NDC, 5 package rows20250523_9286ec0b-45ae-4a09-a0ad-556ec92aab63.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN9286ec0b-45ae-4a09-a0ad-556ec92aab6321
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD9286ec0b-45ae-4a09-a0ad-556ec92aab6321
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY9286ec0b-45ae-4a09-a0ad-556ec92aab6321

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-1139-07051811390030 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (70518-1139-0) 2018-04-250000-00-00NoNoCurrent
70518-1139-17051811390160 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-1139-1) 2025-01-09NoNoHistorical
70518-1139-270518113902180 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-1139-2) 2025-04-16NoNoHistorical
70518-1139-37051811390330 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-1139-3) 2025-06-13NoNoHistorical
70518-1139-47051811390430 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (70518-1139-4) 2025-12-27NoNoHistorical