FDA.reportPublic FDA data

Duloxetine

Product NDC
59651-282
11-digit product format
596510282
Labeler code
59651
Product ID
59651-282_ad4ac841-ec88-467d-9970-ccdbba56bd11
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine Hydrochloride
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA090778
Marketing category
ANDA
Marketing start
2013-12-11
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
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 HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9044SC542W
Rxcui596926, 596930, 596934

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
59651-282-10Duloxetine10 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE1010
59651-282-30Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE3010
59651-282-39Duloxetine3000 in 1 BOTTLECAPSULE, DELAYED RELEASE300010
59651-282-78Duloxetine10 in 1 CARTONCAPSULE, DELAYED RELEASE1010
59651-282-90Duloxetine90 in 1 BOTTLECAPSULE, DELAYED RELEASE9010
59651-282-99Duloxetine1000 in 1 BOTTLECAPSULE, DELAYED RELEASE100010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-282DULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]10Current NDC, Legacy NDC, 6 package rows20241228_3adfceb3-5f89-4bcf-b874-e3cb572a98b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN3adfceb3-5f89-4bcf-b874-e3cb572a98b610
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN3adfceb3-5f89-4bcf-b874-e3cb572a98b610
596934DULoxetine 60 MG Delayed Release Oral CapsulePSN3adfceb3-5f89-4bcf-b874-e3cb572a98b610
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD3adfceb3-5f89-4bcf-b874-e3cb572a98b610
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD3adfceb3-5f89-4bcf-b874-e3cb572a98b610
596934duloxetine 60 MG Delayed Release Oral CapsuleSCD3adfceb3-5f89-4bcf-b874-e3cb572a98b610
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY3adfceb3-5f89-4bcf-b874-e3cb572a98b610
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY3adfceb3-5f89-4bcf-b874-e3cb572a98b610
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY3adfceb3-5f89-4bcf-b874-e3cb572a98b610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59651-282-105965102821010 in 1 BLISTER PACKHistorical
59651-282-305965102823030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-282-30) 2013-12-110000-00-00NoNoCurrent
59651-282-39596510282393000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-282-39) 2013-12-110000-00-00NoNoCurrent
59651-282-785965102827810 BLISTER PACK in 1 CARTON (59651-282-78) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (59651-282-10) 10 blister pack2013-12-110000-00-00NoNoCurrent
59651-282-905965102829090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-282-90) 2013-12-110000-00-00NoNoCurrent
59651-282-99596510282991000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-282-99) 2013-12-110000-00-00NoNoCurrent