FDA.reportPublic FDA data

Duloxetine

Product NDC
47335-383
11-digit product format
473350383
Labeler code
47335
Product ID
47335-383_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
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
47335-383-08Duloxetine100 in 1 BOTTLECAPSULE, DELAYED RELEASE10016
47335-383-18Duloxetine1000 in 1 BOTTLECAPSULE, DELAYED RELEASE100016
47335-383-61Duloxetine1 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE116
47335-383-61Duloxetine100 in 1 CARTONCAPSULE, DELAYED RELEASE10016
47335-383-83Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE3016
47335-383-88Duloxetine100 in 1 BOTTLECAPSULE, DELAYED RELEASE10016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-383-18EA - Each47335-383cd7d0167-d709-4906-8c45-82bb5eea430812014-01-04
47335-383-83EA - Each47335-383312dafab-27aa-4f95-88df-961827e50d7412014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
DULOXETINEACTIVE MOIETYO5TNM5N07UDULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
ALCOHOLINACTIVE INGREDIENT3K9958V90MDULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
AMMONIAINACTIVE INGREDIENT5138Q19F1XDULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3DULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
GELATININACTIVE INGREDIENT2G86QN327LDULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302DULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
MANNITOLINACTIVE INGREDIENT3OWL53L36ADULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TDULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
SHELLACINACTIVE INGREDIENT46N107B71ODULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
SUCROSEINACTIVE INGREDIENTC151H8M554DULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
TALCINACTIVE INGREDIENT7SEV7J4R1UDULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
WATERINACTIVE INGREDIENT059QF0KO0RDULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]6
DULOXETINEACTIVE MOIETYO5TNM5N07UDULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]6
ALCOHOLINACTIVE INGREDIENT3K9958V90MDULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]6
AMMONIAINACTIVE INGREDIENT5138Q19F1XDULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]6
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3DULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]6
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]6
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]6
GELATININACTIVE INGREDIENT2G86QN327LDULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]6
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302DULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]6
MANNITOLINACTIVE INGREDIENT3OWL53L36ADULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]6
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]6
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TDULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]6
SHELLACINACTIVE INGREDIENT46N107B71ODULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]6
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]6
SUCROSEINACTIVE INGREDIENTC151H8M554DULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]6
TALCINACTIVE INGREDIENT7SEV7J4R1UDULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]6
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]6
WATERINACTIVE INGREDIENT059QF0KO0RDULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-383DULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]16Current NDC, Legacy NDC, 6 package rows20211113_f16beb64-5878-486a-82ee-8e83e728f26c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596934DULoxetine 60 MG Delayed Release Oral CapsulePSNfe3e2db6-1aee-4767-bc1f-8547bac4b41a1001
596934duloxetine 60 MG Delayed Release Oral CapsuleSCDfe3e2db6-1aee-4767-bc1f-8547bac4b41a1001
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSYfe3e2db6-1aee-4767-bc1f-8547bac4b41a1001
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47335-383-0847335038308100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-383-08) 2013-12-110000-00-00NoNoCurrent
47335-383-18473350383181000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-383-18) 2013-12-110000-00-00NoNoCurrent
47335-383-6147335038361100 BLISTER PACK in 1 CARTON (47335-383-61) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK100 blister pack2013-12-110000-00-00NoNoCurrent
47335-383-834733503838330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-383-83) 2013-12-110000-00-00NoNoCurrent
47335-383-8847335038388100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-383-88) 2013-12-110000-00-00NoNoCurrent