FDA.reportPublic FDA data

Duloxetine

Product NDC
65841-801
11-digit product format
658410801
Labeler code
65841
Product ID
65841-801_22968719-7127-4aab-b4c4-4497de16ca23
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA090739
Marketing category
ANDA
Marketing start
2014-05-27
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
65841-801-06Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE307
65841-801-10Duloxetine1000 in 1 BOTTLECAPSULE, DELAYED RELEASE10007
65841-801-16Duloxetine90 in 1 BOTTLECAPSULE, DELAYED RELEASE907

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED]1
DULOXETINEACTIVE MOIETYO5TNM5N07UDULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MDULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XDULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3DULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED]1
GELATININACTIVE INGREDIENT2G86QN327LDULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED]1
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)INACTIVE INGREDIENTG4U024CQK6DULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302DULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED]1
SHELLACINACTIVE INGREDIENT46N107B71ODULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED]1
SUCROSEINACTIVE INGREDIENTC151H8M554DULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-801DULOXETINE CAPSULE, DELAYED RELEASE [ZYDUS LIFESCIENCES LIMITED]7Current NDC, Legacy NDC, 3 package rows20241201_f36b414e-ace4-4f04-a80f-75bb25db430d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596926DULoxetine 20 MG Delayed Release Oral CapsulePSNf36b414e-ace4-4f04-a80f-75bb25db430d7
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNf36b414e-ace4-4f04-a80f-75bb25db430d7
596934DULoxetine 60 MG Delayed Release Oral CapsulePSNf36b414e-ace4-4f04-a80f-75bb25db430d7
596926duloxetine 20 MG Delayed Release Oral CapsuleSCDf36b414e-ace4-4f04-a80f-75bb25db430d7
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDf36b414e-ace4-4f04-a80f-75bb25db430d7
596934duloxetine 60 MG Delayed Release Oral CapsuleSCDf36b414e-ace4-4f04-a80f-75bb25db430d7
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSYf36b414e-ace4-4f04-a80f-75bb25db430d7
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYf36b414e-ace4-4f04-a80f-75bb25db430d7
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSYf36b414e-ace4-4f04-a80f-75bb25db430d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65841-801-066584108010630 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-801-06) 2014-05-270000-00-00NoNoCurrent
65841-801-10658410801101000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-801-10) 2014-05-270000-00-00NoNoCurrent
65841-801-166584108011690 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-801-16) 2014-05-270000-00-00NoNoCurrent