FDA.reportPublic FDA data

Duloxetine

Product NDC
82009-029
11-digit product format
820090029
Labeler code
82009
Product ID
82009-029_c7833be1-34d9-43e4-8aff-966c14aa2798
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DULOXETINE HYDROCHLORIDE
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Quallent Pharmaceuticals Health, LLC
Application
ANDA203088
Marketing category
ANDA
Marketing start
2014-06-11
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
82009-029-05Duloxetine500 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS5005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82009-029-05EA - Each82009-029e618441d-a587-4298-a1ab-989320665e8912023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82009-029DULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [QUALLENT PHARMACEUTICALS HEALTH, LLC]4Current NDC, Legacy NDC, 1 package rows20250309_31362045-201f-45f3-99f2-a5e322a0c30b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN31362045-201f-45f3-99f2-a5e322a0c30b5
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN31362045-201f-45f3-99f2-a5e322a0c30b5
616402DULoxetine 40 MG Delayed Release Oral CapsulePSN31362045-201f-45f3-99f2-a5e322a0c30b5
596934DULoxetine 60 MG Delayed Release Oral CapsulePSN31362045-201f-45f3-99f2-a5e322a0c30b5
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD31362045-201f-45f3-99f2-a5e322a0c30b5
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD31362045-201f-45f3-99f2-a5e322a0c30b5
616402duloxetine 40 MG Delayed Release Oral CapsuleSCD31362045-201f-45f3-99f2-a5e322a0c30b5
596934duloxetine 60 MG Delayed Release Oral CapsuleSCD31362045-201f-45f3-99f2-a5e322a0c30b5
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY31362045-201f-45f3-99f2-a5e322a0c30b5
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY31362045-201f-45f3-99f2-a5e322a0c30b5
616402duloxetine 40 MG (as duloxetine HCl 44.9 MG) Delayed Release Oral CapsuleSY31362045-201f-45f3-99f2-a5e322a0c30b5
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY31362045-201f-45f3-99f2-a5e322a0c30b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
82009-029-0582009002905500 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (82009-029-05) 2022-12-150000-00-00NoNoCurrent