FDA.reportPublic FDA data

Duloxetine D/R

Product NDC
72189-615
11-digit product format
721890615
Labeler code
72189
Product ID
72189-615_35ced01c-03fc-4779-e063-6394a90a9cd5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine D/R
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA090694
Marketing category
ANDA
Marketing start
2025-02-17
Substance
DULOXETINE HYDROCHLORIDE
Active strength
30 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 D/R
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DULOXETINE HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9044SC542W
Rxcui596930

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
72189-615-30Duloxetine D/R30 in 1 BOTTLECAPSULE, DELAYED RELEASE303
72189-615-60Duloxetine D/R60 in 1 BOTTLECAPSULE, DELAYED RELEASE603
72189-615-90Duloxetine D/R90 in 1 BOTTLECAPSULE, DELAYED RELEASE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-615DULOXETINE D/R CAPSULE, DELAYED RELEASE [DIRECT_RX]3Current NDC, 3 package rows20250524_2e58add7-b85e-2772-e063-6294a90a580d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN2e58add7-b85e-2772-e063-6294a90a580d3
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD2e58add7-b85e-2772-e063-6294a90a580d3
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY2e58add7-b85e-2772-e063-6294a90a580d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72189-615-307218906153030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72189-615-30) 2025-02-17NoNoCurrent
72189-615-607218906156060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72189-615-60) 2025-02-17NoNoCurrent
72189-615-907218906159090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72189-615-90) 2025-02-17NoNoCurrent