FDA.reportPublic FDA data

Duloxetine

Product NDC
68788-8782
11-digit product format
687888782
Labeler code
68788
Product ID
68788-8782_c45d0905-3478-4da4-b114-9f4cfb4a58ef
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
2024-12-11
Substance
DULOXETINE HYDROCHLORIDE
Active strength
40 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 HYDROCHLORIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9044SC542W
Rxcui616402

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
68788-8782-3Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE302
68788-8782-6Duloxetine60 in 1 BOTTLECAPSULE, DELAYED RELEASE602
68788-8782-9Duloxetine90 in 1 BOTTLECAPSULE, DELAYED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8782-3EA - Each68788-87820fc9353e-89a2-4cc1-9142-d3a768c3232512025-01-14
68788-8782-6EA - Each68788-8782e78206a5-d5a0-4ffc-97b3-a0724652566f12025-01-14
68788-8782-9EA - Each68788-8782f877f0e4-74ef-48e0-9c2f-461eb350812e12025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8782DULOXETINE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 3 package rows20241219_ae381859-be09-43e1-8b56-d0d8f4b49020.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616402DULoxetine 40 MG Delayed Release Oral CapsulePSNae381859-be09-43e1-8b56-d0d8f4b490202
616402duloxetine 40 MG Delayed Release Oral CapsuleSCDae381859-be09-43e1-8b56-d0d8f4b490202
616402duloxetine 40 MG (as duloxetine HCl 44.9 MG) Delayed Release Oral CapsuleSYae381859-be09-43e1-8b56-d0d8f4b490202

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8782-36878887820330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8782-3) 2024-12-11NoNoHistorical
68788-8782-66878887820660 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8782-6) 2024-12-11NoNoHistorical
68788-8782-96878887820990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8782-9) 2024-12-11NoNoHistorical