FDA.reportPublic FDA data

Duloxetine

Product NDC
68788-4026
11-digit product format
687884026
Labeler code
68788
Product ID
68788-4026_c5aac428-d929-4688-a9d5-4e9314aa62cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Preferred Phamaceuticals Inc.
Application
ANDA090776
Marketing category
ANDA
Marketing start
2025-09-15
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
Rxcui596930, 596934

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
68788-4026-3Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS301
68788-4026-6Duloxetine60 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS601
68788-4026-9Duloxetine90 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-4026-3EA - Each68788-4026c914248c-d9ea-4d2e-9d4e-46ecf612f7e812025-11-13
68788-4026-6EA - Each68788-4026030ddab2-9233-4dc9-8d57-1cde15195ef112025-11-13
68788-4026-9EA - Each68788-4026e73dc6d0-0172-4f3b-8130-fa9d679eaed212025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNc5aac428-d929-4688-a9d5-4e9314aa62cc1
596934DULoxetine 60 MG Delayed Release Oral CapsulePSNc5aac428-d929-4688-a9d5-4e9314aa62cc1
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDc5aac428-d929-4688-a9d5-4e9314aa62cc1
596934duloxetine 60 MG Delayed Release Oral CapsuleSCDc5aac428-d929-4688-a9d5-4e9314aa62cc1
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYc5aac428-d929-4688-a9d5-4e9314aa62cc1
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSYc5aac428-d929-4688-a9d5-4e9314aa62cc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-4026-36878840260330 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-4026-3) 2025-09-15NoNoCurrent
68788-4026-66878840260660 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-4026-6) 2025-09-15NoNoCurrent
68788-4026-96878840260990 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-4026-9) 2025-09-15NoNoCurrent