FDA.reportPublic FDA data

Duloxetine

Product NDC
82009-170
11-digit product format
820090170
Labeler code
82009
Product ID
82009-170_8bd1cf58-1f36-4c7e-a549-24bb4ec3e154
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Quallent Pharmaceuticals Health LLC
Application
ANDA208706
Marketing category
ANDA
Marketing start
2025-07-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Duloxetine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DULOXETINE HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9044SC542W
Rxcui596926, 596930, 596934, 616402

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
82009-170-10Duloxetine1000 in 1 BOTTLECAPSULE, DELAYED RELEASE10003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596926DULoxetine 20 MG Delayed Release Oral CapsulePSNb3b26383-9924-40f9-b4bb-43e30b70493e3
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNb3b26383-9924-40f9-b4bb-43e30b70493e3
616402DULoxetine 40 MG Delayed Release Oral CapsulePSNb3b26383-9924-40f9-b4bb-43e30b70493e3
596934DULoxetine 60 MG Delayed Release Oral CapsulePSNb3b26383-9924-40f9-b4bb-43e30b70493e3
596926duloxetine 20 MG Delayed Release Oral CapsuleSCDb3b26383-9924-40f9-b4bb-43e30b70493e3
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDb3b26383-9924-40f9-b4bb-43e30b70493e3
616402duloxetine 40 MG Delayed Release Oral CapsuleSCDb3b26383-9924-40f9-b4bb-43e30b70493e3
596934duloxetine 60 MG Delayed Release Oral CapsuleSCDb3b26383-9924-40f9-b4bb-43e30b70493e3
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSYb3b26383-9924-40f9-b4bb-43e30b70493e3
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYb3b26383-9924-40f9-b4bb-43e30b70493e3
616402duloxetine 40 MG (as duloxetine HCl 44.9 MG) Delayed Release Oral CapsuleSYb3b26383-9924-40f9-b4bb-43e30b70493e3
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSYb3b26383-9924-40f9-b4bb-43e30b70493e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82009-170-10820090170101000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82009-170-10) 2025-07-01NoNoCurrent