FDA.reportPublic FDA data

Duloxetine

Product NDC
70518-3287
11-digit product format
705183287
Labeler code
70518
Product ID
70518-3287_52192c8c-c943-b2f7-e063-6294a90ac21a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA208706
Marketing category
ANDA
Marketing start
2021-12-09
Substance
DULOXETINE HYDROCHLORIDE
Active strength
30 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 HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9044SC542W
Rxcui596930

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
70518-3287-0Duloxetine60 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE6012
70518-3287-1Duloxetine30 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE3012
70518-3287-2Duloxetine90 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE9012
70518-3287-3Duloxetine50 in 1 BOXCAPSULE, DELAYED RELEASE5012
70518-3287-4Duloxetine1 in 1 POUCHCAPSULE, DELAYED RELEASE112
70518-3287-5Duloxetine50 in 1 BOXCAPSULE, DELAYED RELEASE5012
70518-3287-6Duloxetine1 in 1 POUCHCAPSULE, DELAYED RELEASE112

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3287DULOXETINE CAPSULE, DELAYED RELEASE [REMEDYREPACK INC.]6Current NDC, Legacy NDC, 7 package rows20250509_ed164dbb-e713-42d1-a78e-31145578b9f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNed164dbb-e713-42d1-a78e-31145578b9f812
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDed164dbb-e713-42d1-a78e-31145578b9f812
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYed164dbb-e713-42d1-a78e-31145578b9f812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3287-07051832870060 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-3287-0) 2021-12-090000-00-00NoNoCurrent
70518-3287-17051832870130 in 1 BLISTER PACKHistorical
70518-3287-27051832870290 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-3287-2) 2025-05-28NoNoHistorical
70518-3287-37051832870350 POUCH in 1 BOX (70518-3287-3) / 1 CAPSULE, DELAYED RELEASE in 1 POUCH (70518-3287-4) 50 pouch2026-04-23NoNoHistorical
70518-3287-4705183287041 in 1 POUCHHistorical
70518-3287-57051832870550 POUCH in 1 BOX (70518-3287-5) / 1 CAPSULE, DELAYED RELEASE in 1 POUCH (70518-3287-6) 50 pouch2026-05-15NoNoHistorical
70518-3287-6705183287061 in 1 POUCHHistorical