FDA.reportPublic FDA data

Duloxetine

Product NDC
68788-8362
11-digit product format
687888362
Labeler code
68788
Product ID
68788-8362_19b034a2-26d7-4c9b-b8a6-391e06a31adb
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
2023-02-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Duloxetine
Brand name suffix
Delayed-Release
Listing expiration
2026-12-31

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
68788-8362-0DuloxetineDelayed-Release60 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS605
68788-8362-3DuloxetineDelayed-Release30 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS305
68788-8362-6DuloxetineDelayed-Release63 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS635
68788-8362-9DuloxetineDelayed-Release90 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8362-0EA - Each68788-8362e0eec225-a064-4a94-8dda-bbde3f866f7f12023-04-07
68788-8362-3EA - Each68788-8362c20c4b86-7686-44ed-8464-3c9d5cb7f34712023-03-13
68788-8362-6EA - Each68788-836217e2ee2a-e9f5-4c73-af2e-cadc31dc2f4812023-03-13
68788-8362-9EA - Each68788-8362543119f7-ba95-4fc1-82e1-35b0115fa35312023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8362DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [PREFERRED PHARMACEUTICALS INC.]5Current NDC, 4 package rows20250406_2c233b3f-83de-40c4-9f1d-81f901f89459.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616402DULoxetine 40 MG Delayed Release Oral CapsulePSN2c233b3f-83de-40c4-9f1d-81f901f894595
616402duloxetine 40 MG Delayed Release Oral CapsuleSCD2c233b3f-83de-40c4-9f1d-81f901f894595
616402duloxetine 40 MG (as duloxetine HCl 44.9 MG) Delayed Release Oral CapsuleSY2c233b3f-83de-40c4-9f1d-81f901f894595

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8362-06878883620060 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-8362-0) 2023-03-14NoNoHistorical
68788-8362-36878883620330 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-8362-3) 2023-02-01NoNoHistorical
68788-8362-66878883620663 in 1 BOTTLEHistorical
68788-8362-96878883620990 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-8362-9) 2023-02-01NoNoHistorical