FDA.reportPublic FDA data

Duloxetine

Product NDC
64725-7544
11-digit product format
647257544
Labeler code
64725
Product ID
64725-7544_e57024b0-ec2c-4e78-9294-646374b41871
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
TYA Pharmaceuticals
Application
ANDA090783
Marketing category
ANDA
Marketing start
2013-12-11
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
64725-7544-12019-11-27C16284748780-19855e2a2-3711-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use duloxetine delayed-release capsules USP safely and effectively. See full prescribing information for duloxetine delayed-release capsules USP. DULOXETINE delayed-release capsules USP for oral use Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-7544-1Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE302

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]2
DULOXETINEACTIVE MOIETYO5TNM5N07UDULOXETINE CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDULOXETINE CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDULOXETINE CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SDULOXETINE CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DULOXETINE CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]2
GELATININACTIVE INGREDIENT2G86QN327LDULOXETINE CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]2
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82DULOXETINE CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6DULOXETINE CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]2
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)INACTIVE INGREDIENTG4U024CQK6DULOXETINE CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDULOXETINE CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TDULOXETINE CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]2
POVIDONE K30INACTIVE INGREDIENTU725QWY32XDULOXETINE CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DULOXETINE CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]2
SHELLACINACTIVE INGREDIENT46N107B71ODULOXETINE CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DULOXETINE CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDULOXETINE CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDULOXETINE CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]2
SUCROSEINACTIVE INGREDIENTC151H8M554DULOXETINE CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]2
TALCINACTIVE INGREDIENT7SEV7J4R1UDULOXETINE CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDULOXETINE CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDULOXETINE CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-7544DULOXETINE CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]2Legacy NDC, 1 package rows20140904_1ead9bc0-6d69-4752-b124-3004e256938e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596934DULoxetine 60 MG Delayed Release Oral CapsulePSN1ead9bc0-6d69-4752-b124-3004e256938e2
596934duloxetine 60 MG Delayed Release Oral CapsuleSCD1ead9bc0-6d69-4752-b124-3004e256938e2
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY1ead9bc0-6d69-4752-b124-3004e256938e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64725-7544-16472575440130 in 1 BOTTLEHistorical