FDA.reportPublic FDA data

Duloxetine

Product NDC
60429-166
11-digit product format
604290166
Labeler code
60429
Product ID
60429-166_e42d9c22-0ac5-85af-e053-2a95a90a9eec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DULOXETINE HYDROCHLORIDE
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA203088
Marketing category
ANDA
Marketing start
2014-06-11
Marketing end
0000-00-00
Substance
DULOXETINE HYDROCHLORIDE
Active strength
60 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60429-166-10DuloxetineDelayed-Release1000 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS100020
60429-166-30DuloxetineDelayed-Release30 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS3020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-166-10EA - Each60429-1668846d3fc-314c-4715-9da2-528a7ffaae3612014-07-02
60429-166-30EA - Each60429-16674c9ddd2-2d8e-48c9-a680-3fde99f8b2e212014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]2
DULOXETINEACTIVE MOIETYO5TNM5N07UDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]2
SHELLACINACTIVE INGREDIENT46N107B71ODULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60429-166DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]19Legacy NDC, 2 package rows20250411_f535fcd2-a50a-4423-85d9-705fd2d9a470.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596926DULoxetine 20 MG Delayed Release Oral CapsulePSNf535fcd2-a50a-4423-85d9-705fd2d9a47020
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNf535fcd2-a50a-4423-85d9-705fd2d9a47020
596934DULoxetine 60 MG Delayed Release Oral CapsulePSNf535fcd2-a50a-4423-85d9-705fd2d9a47020
596926duloxetine 20 MG Delayed Release Oral CapsuleSCDf535fcd2-a50a-4423-85d9-705fd2d9a47020
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDf535fcd2-a50a-4423-85d9-705fd2d9a47020
596934duloxetine 60 MG Delayed Release Oral CapsuleSCDf535fcd2-a50a-4423-85d9-705fd2d9a47020
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSYf535fcd2-a50a-4423-85d9-705fd2d9a47020
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYf535fcd2-a50a-4423-85d9-705fd2d9a47020
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSYf535fcd2-a50a-4423-85d9-705fd2d9a47020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60429-166-10604290166101000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (60429-166-10) 2014-06-110000-00-00NoNoCurrent
60429-166-306042901663030 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (60429-166-30) 2014-06-110000-00-00NoNoCurrent