FDA.reportPublic FDA data

Duloxetine

Product NDC
45865-816
11-digit product format
458650816
Labeler code
45865
Product ID
45865-816_9ab40f3c-d695-e12a-e053-2995a90a2b3e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA090723
Marketing category
ANDA
Marketing start
2014-06-18
Marketing end
0000-00-00
Substance
DULOXETINE HYDROCHLORIDE
Active strength
60 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
aebfdb62-b550-4c4f-9225-d5d3bbc7ab88Product name920210727
7dd29e28-6b69-499b-9257-12a3b46ca283Product name120191120
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45865-816-302025-01-31C16284748780-1f386c649-a4dc-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use duloxetine safely and effectively. See full prescribing information for duloxetine . DULOXETINE delayed-release capsules USP for oral use. Initial U.S. Approval: 2004
45865-816-302023-01-30C16284748780-1f386c649-a4dc-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use duloxetine safely and effectively. See full prescribing information for duloxetine . DULOXETINE delayed-release capsules USP for oral use. Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-816-30Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS302

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE CAPSULE, DELAYED RELEASE PELLETS [MEDSOURCE PHARMACEUTICALS]1
DULOXETINEACTIVE MOIETYO5TNM5N07UDULOXETINE CAPSULE, DELAYED RELEASE PELLETS [MEDSOURCE PHARMACEUTICALS]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XDULOXETINE CAPSULE, DELAYED RELEASE PELLETS [MEDSOURCE PHARMACEUTICALS]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDULOXETINE CAPSULE, DELAYED RELEASE PELLETS [MEDSOURCE PHARMACEUTICALS]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDULOXETINE CAPSULE, DELAYED RELEASE PELLETS [MEDSOURCE PHARMACEUTICALS]1
GELATININACTIVE INGREDIENT2G86QN327LDULOXETINE CAPSULE, DELAYED RELEASE PELLETS [MEDSOURCE PHARMACEUTICALS]1
GLYCINEINACTIVE INGREDIENTTE7660XO1CDULOXETINE CAPSULE, DELAYED RELEASE PELLETS [MEDSOURCE PHARMACEUTICALS]1
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)INACTIVE INGREDIENTG4U024CQK6DULOXETINE CAPSULE, DELAYED RELEASE PELLETS [MEDSOURCE PHARMACEUTICALS]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODULOXETINE CAPSULE, DELAYED RELEASE PELLETS [MEDSOURCE PHARMACEUTICALS]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TDULOXETINE CAPSULE, DELAYED RELEASE PELLETS [MEDSOURCE PHARMACEUTICALS]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DULOXETINE CAPSULE, DELAYED RELEASE PELLETS [MEDSOURCE PHARMACEUTICALS]1
SHELLACINACTIVE INGREDIENT46N107B71ODULOXETINE CAPSULE, DELAYED RELEASE PELLETS [MEDSOURCE PHARMACEUTICALS]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDULOXETINE CAPSULE, DELAYED RELEASE PELLETS [MEDSOURCE PHARMACEUTICALS]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDULOXETINE CAPSULE, DELAYED RELEASE PELLETS [MEDSOURCE PHARMACEUTICALS]1
SUCROSEINACTIVE INGREDIENTC151H8M554DULOXETINE CAPSULE, DELAYED RELEASE PELLETS [MEDSOURCE PHARMACEUTICALS]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDULOXETINE CAPSULE, DELAYED RELEASE PELLETS [MEDSOURCE PHARMACEUTICALS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDULOXETINE CAPSULE, DELAYED RELEASE PELLETS [MEDSOURCE PHARMACEUTICALS]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDULOXETINE CAPSULE, DELAYED RELEASE PELLETS [MEDSOURCE PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-816DULOXETINE CAPSULE, DELAYED RELEASE PELLETS [MEDSOURCE PHARMACEUTICALS]2Legacy NDC, 1 package rows20191228_2084fc8f-b9f9-65e2-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN2084fc8f-b9f9-65e2-e054-00144ff8d46c2
596934DULoxetine 60 MG Delayed Release Oral CapsulePSN2084fc8f-b9f9-65e2-e054-00144ff8d46c2
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD2084fc8f-b9f9-65e2-e054-00144ff8d46c2
596934duloxetine 60 MG Delayed Release Oral CapsuleSCD2084fc8f-b9f9-65e2-e054-00144ff8d46c2
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY2084fc8f-b9f9-65e2-e054-00144ff8d46c2
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY2084fc8f-b9f9-65e2-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45865-816-304586508163030 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (45865-816-30) 2015-09-220000-00-00NoNoCurrent