FDA.reportPublic FDA data

Duloxetine

Product NDC
68788-8623
11-digit product format
687888623
Labeler code
68788
Product ID
68788-8623_5628b5ce-a32d-4bc3-9171-efe022cf4a37
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA090694
Marketing category
ANDA
Marketing start
2024-04-08
Substance
DULOXETINE HYDROCHLORIDE
Active strength
60 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 HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9044SC542W
Rxcui596934

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
68788-8623-3Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE302
68788-8623-6Duloxetine60 in 1 BOTTLECAPSULE, DELAYED RELEASE602
68788-8623-9Duloxetine90 in 1 BOTTLECAPSULE, DELAYED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8623-3EA - Each68788-8623ac04f8ea-68f0-44ad-8e87-ff275365590e12024-06-10
68788-8623-6EA - Each68788-8623e0b81a13-d012-4e56-9765-74f86c671d4c12024-06-10
68788-8623-9EA - Each68788-86232d5e9727-4f61-47a2-ab81-080f1983dec212024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8623DULOXETINE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 3 package rows20250406_71256b03-867f-4c5e-aa5d-75d1bb705fcb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596934DULoxetine 60 MG Delayed Release Oral CapsulePSN71256b03-867f-4c5e-aa5d-75d1bb705fcb2
596934duloxetine 60 MG Delayed Release Oral CapsuleSCD71256b03-867f-4c5e-aa5d-75d1bb705fcb2
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY71256b03-867f-4c5e-aa5d-75d1bb705fcb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8623-36878886230330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8623-3) 2024-04-08NoNoCurrent
68788-8623-66878886230660 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8623-6) 2024-04-08NoNoCurrent
68788-8623-96878886230990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8623-9) 2024-04-08NoNoCurrent