FDA.reportPublic FDA data

Duloxetine

Product NDC
68788-7897
11-digit product format
687887897
Labeler code
68788
Product ID
68788-7897_d102cca7-8681-4960-8218-2d4dd15647c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DULOXETINE HYDROCHLORIDE
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA203088
Marketing category
ANDA
Marketing start
2021-05-14
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
68788-7897-3DuloxetineDelayed-Release30 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS306
68788-7897-6DuloxetineDelayed-Release60 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS606
68788-7897-9DuloxetineDelayed-Release90 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7897-3EA - Each68788-789700ea097c-7ed1-4d9d-9f95-efa7d905f9e412021-07-15
68788-7897-6EA - Each68788-7897e76b7dfc-b74a-4197-b2da-0eb9c2d3be0e12021-07-15
68788-7897-9EA - Each68788-7897c7ae451f-0c51-4718-b13e-ef786462789112021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7897DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [PREFERRED PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 3 package rows20250406_29eacc40-cbec-4cc9-8556-773346617e85.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN29eacc40-cbec-4cc9-8556-773346617e856
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD29eacc40-cbec-4cc9-8556-773346617e856
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY29eacc40-cbec-4cc9-8556-773346617e856

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7897-36878878970330 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-7897-3) 2021-05-140000-00-00NoNoCurrent
68788-7897-66878878970660 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-7897-6) 2021-05-140000-00-00NoNoCurrent
68788-7897-96878878970990 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-7897-9) 2021-05-140000-00-00NoNoCurrent