FDA.reportPublic FDA data

Duloxetine

Product NDC
70518-0122
11-digit product format
705180122
Labeler code
70518
Product ID
70518-0122_47e297d1-dc2e-3f3b-e063-6294a90a5b53
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DULOXETINE HYDROCHLORIDE
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA203088
Marketing category
ANDA
Marketing start
2017-01-13
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
Brand name suffix
Delayed-Release
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
70518-0122-0DuloxetineDelayed-Release30 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE PELLETS3014
70518-0122-1DuloxetineDelayed-Release30 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE PELLETS3014
70518-0122-2DuloxetineDelayed-Release60 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE PELLETS6014
70518-0122-3DuloxetineDelayed-Release100 in 1 BOXCAPSULE, DELAYED RELEASE PELLETS10014
70518-0122-4DuloxetineDelayed-Release1 in 1 POUCHCAPSULE, DELAYED RELEASE PELLETS114
70518-0122-5DuloxetineDelayed-Release90 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE PELLETS9014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0122DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [REMEDYREPACK INC.]12Current NDC, Legacy NDC, 6 package rows20250529_b9f20917-9529-4c62-bafe-baae7f8d6c77.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596934DULoxetine 60 MG Delayed Release Oral CapsulePSNb9f20917-9529-4c62-bafe-baae7f8d6c7714
596934duloxetine 60 MG Delayed Release Oral CapsuleSCDb9f20917-9529-4c62-bafe-baae7f8d6c7714
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSYb9f20917-9529-4c62-bafe-baae7f8d6c7714

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-0122-07051801220030 in 1 BLISTER PACKHistorical
70518-0122-17051801220130 in 1 BOTTLE, PLASTICHistorical
70518-0122-27051801220260 in 1 BOTTLE, PLASTICHistorical
70518-0122-370518012203100 in 1 BOXHistorical
70518-0122-4705180122041 in 1 POUCHHistorical
70518-0122-57051801220590 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (70518-0122-5) 2024-10-02NoNoCurrent