FDA.reportPublic FDA data

Duloxetine

Product NDC
0615-8496
11-digit product format
006158496
Labeler code
0615
Product ID
0615-8496_3ae078dc-e9a7-441a-b0c2-6ecdbb120a9d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA090694
Marketing category
ANDA
Marketing start
2013-12-11
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Duloxetine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DULOXETINE HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9044SC542W
Rxcui596926, 596930, 596934

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
0615-8496-05Duloxetine15 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE153
0615-8496-28Duloxetine28 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE283
0615-8496-39Duloxetine30 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8496DULOXETINE CAPSULE, DELAYED RELEASE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]3Current NDC, 3 package rows20250105_54749431-430e-4532-97f7-4b1cd8dd252e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN54749431-430e-4532-97f7-4b1cd8dd252e3
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN54749431-430e-4532-97f7-4b1cd8dd252e3
596934DULoxetine 60 MG Delayed Release Oral CapsulePSN54749431-430e-4532-97f7-4b1cd8dd252e3
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD54749431-430e-4532-97f7-4b1cd8dd252e3
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD54749431-430e-4532-97f7-4b1cd8dd252e3
596934duloxetine 60 MG Delayed Release Oral CapsuleSCD54749431-430e-4532-97f7-4b1cd8dd252e3
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY54749431-430e-4532-97f7-4b1cd8dd252e3
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY54749431-430e-4532-97f7-4b1cd8dd252e3
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY54749431-430e-4532-97f7-4b1cd8dd252e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0615-8496-050061584960515 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8496-05) 2023-12-29NoNoHistorical
0615-8496-280061584962828 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8496-28) 2024-12-31NoNoHistorical
0615-8496-390061584963930 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8496-39) 2023-12-29NoNoHistorical