FDA.reportPublic FDA data

Duloxetine

Product NDC
71610-401
11-digit product format
716100401
Labeler code
71610
Product ID
71610-401_157fe8e5-a477-47eb-adac-6b9ffe571af9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine Hydrochloride
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA090778
Marketing category
ANDA
Marketing start
2013-12-11
Substance
DULOXETINE HYDROCHLORIDE
Active strength
20 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 HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9044SC542W
Rxcui596926, 596930

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
71610-401-83Duloxetine3600 in 1 BOTTLECAPSULE, DELAYED RELEASE36001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-401-83EA - Each71610-4011c0e187c-eb2b-4677-82ac-f04e24a80d5e12020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-401DULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 1 package rows20200330_b102b8e6-d58f-419c-bb35-720bafa13294.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
71610-401-83716100401833600 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-401-83) 2020-02-260000-00-00NoNoCurrent