Duloxetine

Product NDC
68151-4727
11-digit product format
681514727
Labeler code
68151
Product ID
68151-4727_9a379a19-a042-42b5-a8b3-52a0f384de06
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine hydrochloride
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Carilion Materials Management
Application
NDA021427
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-01-24
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
E
Listing certified through
2018-12-31
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-4727-3Duloxetine1 in 1 PACKAGECAPSULE, DELAYED RELEASE12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Duloxetine hydrochlorideACTIVE INGREDIENT9044SC542WDULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
DuloxetineACTIVE MOIETYO5TNM5N07UDULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
GELATININACTIVE INGREDIENT2G86QN327LDULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSE ACETATE SUCCINATE 16070722 (3 MM2/S)INACTIVE INGREDIENT24P2YXD2PWDULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
SUCROSEINACTIVE INGREDIENTC151H8M554DULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
TALCINACTIVE INGREDIENT7SEV7J4R1UDULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-4727DULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2Legacy NDC, 1 package rows20140822_7f1c4bec-1cf4-4d10-8c9c-7615fa8f9fae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596934DULoxetine 60 MG Delayed Release Oral CapsulePSN7f1c4bec-1cf4-4d10-8c9c-7615fa8f9fae2
596934duloxetine 60 MG Delayed Release Oral CapsuleSCD7f1c4bec-1cf4-4d10-8c9c-7615fa8f9fae2
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY7f1c4bec-1cf4-4d10-8c9c-7615fa8f9fae2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-4727-3681514727031 in 1 PACKAGEHistorical