FDA.reportPublic FDA data

Duloxetine

Product NDC
47335-381
11-digit product format
473350381
Labeler code
47335
Product ID
47335-381_cec0154d-5c8c-496d-89bd-ba2a93aee774
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA090745
Marketing category
ANDA
Marketing start
2013-12-11
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
aebfdb62-b550-4c4f-9225-d5d3bbc7ab88Product name920210727
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
7dd29e28-6b69-499b-9257-12a3b46ca283Product name120191120
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47335-381-08Duloxetine100 in 1 BOTTLECAPSULE, DELAYED RELEASE10016
47335-381-18Duloxetine1000 in 1 BOTTLECAPSULE, DELAYED RELEASE100016
47335-381-61Duloxetine1 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE116
47335-381-61Duloxetine100 in 1 CARTONCAPSULE, DELAYED RELEASE10016
47335-381-83Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE3016
47335-381-86Duloxetine60 in 1 BOTTLECAPSULE, DELAYED RELEASE6016
47335-381-88Duloxetine100 in 1 BOTTLECAPSULE, DELAYED RELEASE10016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-381DULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]16Current NDC, Legacy NDC, 7 package rows20211113_f16beb64-5878-486a-82ee-8e83e728f26c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596926DULoxetine 20 MG Delayed Release Oral CapsulePSNf16beb64-5878-486a-82ee-8e83e728f26c16
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNf16beb64-5878-486a-82ee-8e83e728f26c16
596934DULoxetine 60 MG Delayed Release Oral CapsulePSNf16beb64-5878-486a-82ee-8e83e728f26c16
596926duloxetine 20 MG Delayed Release Oral CapsuleSCDf16beb64-5878-486a-82ee-8e83e728f26c16
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDf16beb64-5878-486a-82ee-8e83e728f26c16
596934duloxetine 60 MG Delayed Release Oral CapsuleSCDf16beb64-5878-486a-82ee-8e83e728f26c16
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSYf16beb64-5878-486a-82ee-8e83e728f26c16
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYf16beb64-5878-486a-82ee-8e83e728f26c16
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSYf16beb64-5878-486a-82ee-8e83e728f26c16
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN48fb3410-bb87-42ce-e054-00144ff88e882
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD48fb3410-bb87-42ce-e054-00144ff88e882
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY48fb3410-bb87-42ce-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47335-381-0847335038108100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-381-08) 2013-12-110000-00-00NoNoCurrent
47335-381-18473350381181000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-381-18) 2013-12-110000-00-00NoNoCurrent
47335-381-6147335038161100 BLISTER PACK in 1 CARTON (47335-381-61) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK100 blister pack2013-12-110000-00-00NoNoCurrent
47335-381-834733503818330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-381-83) 2013-12-110000-00-00NoNoCurrent
47335-381-864733503818660 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-381-86) 2013-12-110000-00-00NoNoCurrent
47335-381-8847335038188100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-381-88) 2013-12-110000-00-00NoNoCurrent