FDA.reportPublic FDA data

Duloxetine

Product NDC
68788-7935
11-digit product format
687887935
Labeler code
68788
Product ID
68788-7935_21bb27be-d4d6-43de-a441-06334a2bfce4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA208706
Marketing category
ANDA
Marketing start
2021-06-15
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Duloxetine
Listing expiration
2027-12-31

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
68788-7935-3Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE306
68788-7935-6Duloxetine60 in 1 BOTTLECAPSULE, DELAYED RELEASE606
68788-7935-9Duloxetine90 in 1 BOTTLECAPSULE, DELAYED RELEASE906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7935-3EA - Each68788-793511c0c8f1-e7b5-4fa1-8a2a-75a61952ca4712021-07-15
68788-7935-6EA - Each68788-79356da3764f-dc6b-4fab-b711-90f2fb8ce81512021-07-15
68788-7935-9EA - Each68788-793572a19ca6-d6fd-4658-9f9b-9bbc8333065e12021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7935DULOXETINE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 3 package rows20250406_e86eb765-ac9c-4ed9-bce8-819151559394.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNe86eb765-ac9c-4ed9-bce8-8191515593946
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDe86eb765-ac9c-4ed9-bce8-8191515593946
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYe86eb765-ac9c-4ed9-bce8-8191515593946

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7935-36878879350330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7935-3) 2021-06-150000-00-00NoNoCurrent
68788-7935-66878879350660 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7935-6) 2021-06-150000-00-00NoNoCurrent
68788-7935-96878879350990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7935-9) 2021-06-150000-00-00NoNoCurrent