FDA.reportPublic FDA data

Cymbalta

Product NDC
21695-146
11-digit product format
216950146
Labeler code
21695
Product ID
21695-146_7c38b799-9341-4962-914b-fec751123b29
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine hydrochloride
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
NDA021427
Marketing category
NDA
Marketing start
2004-08-24
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
2017-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-146-152019-09-24C16284748780-1934fe258-4761-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use CYMBALTA safely and effectively. See full prescribing information for CYMBALTA. CYMBALTA (duloxetine hydrochloride) capsule, delayed release for oral use Initial U.S. Approval: 2004
21695-146-302019-09-24C16284748780-1934fe258-4761-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use CYMBALTA safely and effectively. See full prescribing information for CYMBALTA. CYMBALTA (duloxetine hydrochloride) capsule, delayed release for oral use Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-146-15Cymbalta15 in 1 BOTTLECAPSULE, DELAYED RELEASE151
21695-146-30Cymbalta30 in 1 BOTTLECAPSULE, DELAYED RELEASE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-146-15EA - Each21695-146ccc94b83-7340-48db-9546-d2485c79047212012-07-24
21695-146-30EA - Each21695-146bba678e4-8ae6-4320-bb40-69596fc7d75412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Duloxetine hydrochlorideACTIVE INGREDIENT9044SC542WCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1
DuloxetineACTIVE MOIETYO5TNM5N07UCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1
GelatinINACTIVE INGREDIENT2G86QN327LCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1
HypromelloseINACTIVE INGREDIENT3NXW29V3WOCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1
HYPROMELLOSE ACETATE SUCCINATE 16070722 (3 MM2/S)INACTIVE INGREDIENT24P2YXD2PWCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1
Sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1
SucroseINACTIVE INGREDIENTC151H8M554CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1
TalcINACTIVE INGREDIENT7SEV7J4R1UCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1
Titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1
Triethyl citrateINACTIVE INGREDIENT8Z96QXD6UMCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-146CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 2 package rows20100625_67927928-c20f-4e12-a327-d26561d7810a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596932Cymbalta 30 MG Delayed Release Oral CapsulePSN67927928-c20f-4e12-a327-d26561d7810a1
615186Cymbalta 60 MG Delayed Release Oral CapsulePSN67927928-c20f-4e12-a327-d26561d7810a1
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN67927928-c20f-4e12-a327-d26561d7810a1
596934DULoxetine 60 MG Delayed Release Oral CapsulePSN67927928-c20f-4e12-a327-d26561d7810a1
596932duloxetine 30 MG Delayed Release Oral Capsule [Cymbalta]SBD67927928-c20f-4e12-a327-d26561d7810a1
615186duloxetine 60 MG Delayed Release Oral Capsule [Cymbalta]SBD67927928-c20f-4e12-a327-d26561d7810a1
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD67927928-c20f-4e12-a327-d26561d7810a1
596934duloxetine 60 MG Delayed Release Oral CapsuleSCD67927928-c20f-4e12-a327-d26561d7810a1
596932Cymbalta 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY67927928-c20f-4e12-a327-d26561d7810a1
596932Cymbalta 30 MG Delayed Release Oral CapsuleSY67927928-c20f-4e12-a327-d26561d7810a1
615186Cymbalta 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY67927928-c20f-4e12-a327-d26561d7810a1
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY67927928-c20f-4e12-a327-d26561d7810a1
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY67927928-c20f-4e12-a327-d26561d7810a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-146-152169501461515 in 1 BOTTLEHistorical
21695-146-302169501463030 in 1 BOTTLEHistorical