FDA.reportPublic FDA data

Duloxetine

Product NDC
57237-018
11-digit product format
572370018
Labeler code
57237
Product ID
57237-018_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
30 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
57237-018-30EA - Each57237-018931e6e7a-638a-4e38-96e2-9c562f6c6a1212014-01-04
57237-018-90EA - Each57237-01884737b03-2d26-40cf-97b5-49bb3136b5de12014-01-04
57237-018-99EA - Each57237-01833f46739-6fc6-4d2a-8ec4-ef0fae9b0af912014-01-04

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
57237-018DULOXETINE (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
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNfc9ad025-88c8-4c3d-8cd0-3ad60a7a47e88
596934DULoxetine 60 MG Delayed Release Oral CapsulePSNfc9ad025-88c8-4c3d-8cd0-3ad60a7a47e88
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDfc9ad025-88c8-4c3d-8cd0-3ad60a7a47e88
596934duloxetine 60 MG Delayed Release Oral CapsuleSCDfc9ad025-88c8-4c3d-8cd0-3ad60a7a47e88
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYfc9ad025-88c8-4c3d-8cd0-3ad60a7a47e88
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSYfc9ad025-88c8-4c3d-8cd0-3ad60a7a47e88
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNafd59273-75cb-5f33-e053-2995a90ab25f7
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDafd59273-75cb-5f33-e053-2995a90ab25f7
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYafd59273-75cb-5f33-e053-2995a90ab25f7
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNc34f6115-f447-450f-8c83-58f3c51a76c93
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDc34f6115-f447-450f-8c83-58f3c51a76c93
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYc34f6115-f447-450f-8c83-58f3c51a76c93
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
57237-018-305723700183030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-018-30) 2013-12-110000-00-00NoNoCurrent
57237-018-905723700189090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-018-90) 2013-12-110000-00-00NoNoCurrent
57237-018-99572370018991000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-018-99) 2013-12-110000-00-00NoNoCurrent