FDA.reportPublic FDA data

Duloxetine

Product NDC
71610-736
11-digit product format
716100736
Labeler code
71610
Product ID
71610-736_0c2b6f3c-0c28-4eff-be0d-cf22961050a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DULOXETINE HYDROCHLORIDE
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA203088
Marketing category
ANDA
Marketing start
2014-06-11
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
Brand name suffix
Delayed-Release
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
71610-736-42DuloxetineDelayed-Release1800 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS18001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-736DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, 1 package rows20230916_dcfd62c7-1687-4e9b-9ae4-5a44929ac765.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNdcfd62c7-1687-4e9b-9ae4-5a44929ac7651
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDdcfd62c7-1687-4e9b-9ae4-5a44929ac7651
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYdcfd62c7-1687-4e9b-9ae4-5a44929ac7651

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71610-736-42716100736421800 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-736-42) 2023-09-15NoNoHistorical