FDA.reportPublic FDA data

Duloxetine

Product NDC
57237-017
11-digit product format
572370017
Labeler code
57237
Product ID
57237-017_2b6955c1-cf12-4eda-8c56-da945b47fdc8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine Hydrochloride
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Rising Health, LLC
Application
ANDA090778
Marketing category
ANDA
Marketing start
2013-12-11
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
No
Listing certified through
2022-12-31
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-017-60EA - Each57237-017feab3c33-4f26-4de0-b3e0-e1da3337350612014-01-04
57237-017-99EA - Each57237-0179a1ce1ca-425c-4f3b-aede-fdd8c31883a412017-09-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CITRON PHARMA LLC]5
DULOXETINEACTIVE MOIETYO5TNM5N07UDULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CITRON PHARMA LLC]5
AMMONIAINACTIVE INGREDIENT5138Q19F1XDULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CITRON PHARMA LLC]5
CROSPOVIDONEINACTIVE INGREDIENT68401960MKDULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CITRON PHARMA LLC]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CITRON PHARMA LLC]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CITRON PHARMA LLC]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CITRON PHARMA LLC]5
GELATININACTIVE INGREDIENT2G86QN327LDULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CITRON PHARMA LLC]5
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PDULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CITRON PHARMA LLC]5
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4DULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CITRON PHARMA LLC]5
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)INACTIVE INGREDIENT87Y6436BKRDULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CITRON PHARMA LLC]5
METHYLENE CHLORIDEINACTIVE INGREDIENT588X2YUY0ADULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CITRON PHARMA LLC]5
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TDULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CITRON PHARMA LLC]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CITRON PHARMA LLC]5
SHELLACINACTIVE INGREDIENT46N107B71ODULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CITRON PHARMA LLC]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CITRON PHARMA LLC]5
SUCROSEINACTIVE INGREDIENTC151H8M554DULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CITRON PHARMA LLC]5
TALCINACTIVE INGREDIENT7SEV7J4R1UDULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CITRON PHARMA LLC]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CITRON PHARMA LLC]5
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [CITRON PHARMA LLC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-017DULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [RISING PHARMA HOLDINGS, INC.]20Legacy NDC20241023_ea2dc1a6-22d5-4295-9d39-9bf015dc5a89.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596926DULoxetine 20 MG Delayed Release Oral CapsulePSNb102b8e6-d58f-419c-bb35-720bafa132941
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNb102b8e6-d58f-419c-bb35-720bafa132941
596926duloxetine 20 MG Delayed Release Oral CapsuleSCDb102b8e6-d58f-419c-bb35-720bafa132941
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDb102b8e6-d58f-419c-bb35-720bafa132941
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSYb102b8e6-d58f-419c-bb35-720bafa132941
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYb102b8e6-d58f-419c-bb35-720bafa132941

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57237-017-605723700176060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-017-60) 2013-12-110000-00-00NoNoCurrent
57237-017-99572370017991000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-017-99) 2013-12-110000-00-00NoNoCurrent