Cymbalta

Product NDC
68151-4734
11-digit product format
681514734
Labeler code
68151
Product ID
68151-4734_c60443d0-b482-44d2-9479-4b7998dd7eed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine hydrochloride
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Carilion Materials Management
Application
NDA021427
Marketing category
NDA
Marketing start
2004-08-24
Marketing end
0000-00-00
Substance
DULOXETINE HYDROCHLORIDE
Active strength
20 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
68151-4734-6Cymbalta1 in 1 PACKAGECAPSULE, DELAYED RELEASE13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Duloxetine hydrochlorideACTIVE INGREDIENT9044SC542WCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
DuloxetineACTIVE MOIETYO5TNM5N07UCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
GELATININACTIVE INGREDIENT2G86QN327LCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSE ACETATE SUCCINATE 16070722 (3 MM2/S)INACTIVE INGREDIENT24P2YXD2PWCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
SUCROSEINACTIVE INGREDIENTC151H8M554CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
TALCINACTIVE INGREDIENT7SEV7J4R1UCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-4734CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]3Legacy NDC, 1 package rows20160806_00acd9e9-b26a-4626-949e-112ecd2f27e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596928Cymbalta 20 MG Delayed Release Oral CapsulePSN00acd9e9-b26a-4626-949e-112ecd2f27e63
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN00acd9e9-b26a-4626-949e-112ecd2f27e63
596928duloxetine 20 MG Delayed Release Oral Capsule [Cymbalta]SBD00acd9e9-b26a-4626-949e-112ecd2f27e63
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD00acd9e9-b26a-4626-949e-112ecd2f27e63
596928Cymbalta 20 MG (as duloxetine hydrochloride 22.4 MG) Delayed Release Oral CapsuleSY00acd9e9-b26a-4626-949e-112ecd2f27e63
596928Cymbalta 20 MG Delayed Release Oral CapsuleSY00acd9e9-b26a-4626-949e-112ecd2f27e63
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY00acd9e9-b26a-4626-949e-112ecd2f27e63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-4734-6681514734061 in 1 PACKAGEHistorical