FDA.reportPublic FDA data

Duloxetine

Product NDC
72162-1597
11-digit product format
721621597
Labeler code
72162
Product ID
72162-1597_9f31e892-c621-4a83-98a3-41e2fcd53f8e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DULOXETINE HYDROCHLORIDE
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203088
Marketing category
ANDA
Marketing start
2014-06-11
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
Brand name suffix
Delayed-Release
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DULOXETINE HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9044SC542W
Rxcui596926

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
72162-1597-5Duloxetine Delayed-Release500 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS500102
72162-1597-9Duloxetine Delayed-Release90 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS90102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1597-5EA - Each72162-1597fd56a54e-9a82-48db-989f-c9fc3bf91f7212024-08-12
72162-1597-9EA - Each72162-1597ed4eb539-c1fb-41f1-91e9-7eb5a6622a7212024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1597DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]102Current NDC, 2 package rows20250403_a5804a0b-ceae-4ebd-bba0-bfc10e21b90d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596926DULoxetine 20 MG Delayed Release Oral CapsulePSNa5804a0b-ceae-4ebd-bba0-bfc10e21b90d102
596926duloxetine 20 MG Delayed Release Oral CapsuleSCDa5804a0b-ceae-4ebd-bba0-bfc10e21b90d102
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSYa5804a0b-ceae-4ebd-bba0-bfc10e21b90d102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-1597-572162159705500 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (72162-1597-5) 2024-02-05NoNoHistorical
72162-1597-97216215970990 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (72162-1597-9) 2024-02-05NoNoHistorical