FDA.reportPublic FDA data

Duloxetine

Product NDC
68788-8608
11-digit product format
687888608
Labeler code
68788
Product ID
68788-8608_bfb65611-4b5e-4959-84a8-fd90fc2bafdc
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
2024-03-20
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
68788-8608-3Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE303
68788-8608-6Duloxetine60 in 1 BOTTLECAPSULE, DELAYED RELEASE603
68788-8608-9Duloxetine90 in 1 BOTTLECAPSULE, DELAYED RELEASE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8608-3EA - Each68788-8608838ef497-7e7d-41cb-b1da-2768f406097212024-06-10
68788-8608-6EA - Each68788-8608e7453958-453b-41ca-a28c-b99b010e24ed12024-06-10
68788-8608-9EA - Each68788-8608583cef31-11e7-4a9b-94fe-9fcc7d1b0b0712024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8608DULOXETINE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 3 package rows20250406_9141b9d3-8d4d-43ec-acf9-e1b620590c4b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN9141b9d3-8d4d-43ec-acf9-e1b620590c4b3
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD9141b9d3-8d4d-43ec-acf9-e1b620590c4b3
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY9141b9d3-8d4d-43ec-acf9-e1b620590c4b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8608-36878886080330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8608-3) 2024-03-20NoNoHistorical
68788-8608-66878886080660 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8608-6) 2024-03-20NoNoHistorical
68788-8608-96878886080990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8608-9) 2024-03-20NoNoHistorical