FDA.reportPublic FDA data

Duloxetine

Product NDC
67877-265
11-digit product format
678770265
Labeler code
67877
Product ID
67877-265_958fae45-5e7a-4f8b-80b7-5934222747b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA203197
Marketing category
ANDA
Marketing start
2012-05-01
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
67877-265-01Duloxetine100 in 1 BOTTLECAPSULE, DELAYED RELEASE10024
67877-265-10Duloxetine1000 in 1 BOTTLECAPSULE, DELAYED RELEASE100024
67877-265-30Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE3024
67877-265-90Duloxetine90 in 1 BOTTLECAPSULE, DELAYED RELEASE9024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-265-10EA - Each67877-2657aec1a88-2471-430a-9664-b4a26a20c1ad12019-10-07
67877-265-30EA - Each67877-2658bc6bda9-144e-4df4-bd16-fa77a69a7e4e12019-10-07
67877-265-90EA - Each67877-265cd704fd0-e614-47de-876d-9dd2e5b85fb512019-10-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]8
DULOXETINEACTIVE MOIETYO5TNM5N07UDULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]8
ALCOHOLINACTIVE INGREDIENT3K9958V90MDULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]8
AMMONIAINACTIVE INGREDIENT5138Q19F1XDULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]8
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3DULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]8
CROSPOVIDONEINACTIVE INGREDIENT68401960MKDULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]8
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]8
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]8
GELATININACTIVE INGREDIENT2G86QN327LDULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]8
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PDULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]8
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)INACTIVE INGREDIENT87Y6436BKRDULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]8
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302DULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]8
METHYLENE CHLORIDEINACTIVE INGREDIENT588X2YUY0ADULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]8
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TDULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]8
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]8
SHELLACINACTIVE INGREDIENT46N107B71ODULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]8
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]8
SUCROSEINACTIVE INGREDIENTC151H8M554DULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]8
TALCINACTIVE INGREDIENT7SEV7J4R1UDULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]8
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-265DULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]22Current NDC, Legacy NDC, 4 package rows20231130_e6477c41-97a2-45a7-94b5-487aa65199f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596926DULoxetine 20 MG Delayed Release Oral CapsulePSNe6477c41-97a2-45a7-94b5-487aa65199f624
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNe6477c41-97a2-45a7-94b5-487aa65199f624
596934DULoxetine 60 MG Delayed Release Oral CapsulePSNe6477c41-97a2-45a7-94b5-487aa65199f624
596926duloxetine 20 MG Delayed Release Oral CapsuleSCDe6477c41-97a2-45a7-94b5-487aa65199f624
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDe6477c41-97a2-45a7-94b5-487aa65199f624
596934duloxetine 60 MG Delayed Release Oral CapsuleSCDe6477c41-97a2-45a7-94b5-487aa65199f624
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSYe6477c41-97a2-45a7-94b5-487aa65199f624
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYe6477c41-97a2-45a7-94b5-487aa65199f624
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSYe6477c41-97a2-45a7-94b5-487aa65199f624

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67877-265-0167877026501100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-265-01) 2012-05-010000-00-00NoNoCurrent
67877-265-10678770265101000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-265-10) 2012-05-010000-00-00NoNoCurrent
67877-265-306787702653030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-265-30) 2012-05-010000-00-00NoNoCurrent
67877-265-906787702659090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-265-90) 2012-05-010000-00-00NoNoCurrent