FDA.reportPublic FDA data

Duloxetine

Product NDC
50090-6281
11-digit product format
500906281
Labeler code
50090
Product ID
50090-6281_4f9b7612-62e9-4f25-8c6f-cceee1337ac8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090694
Marketing category
ANDA
Marketing start
2013-12-11
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
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 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
50090-6281-0Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE3012
50090-6281-1Duloxetine90 in 1 BOTTLECAPSULE, DELAYED RELEASE9012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6281-0EA - Each50090-62817e832e2f-4e3b-4329-a710-312631ba54a812024-02-14
50090-6281-1EA - Each50090-6281a299e36f-3225-4b44-888a-53dd279f270212024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6281DULOXETINE CAPSULE, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]10Current NDC, Legacy NDC, 2 package rows20240612_e2352870-3582-4d92-8712-87ad8bdccb87.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNe2352870-3582-4d92-8712-87ad8bdccb8712
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDe2352870-3582-4d92-8712-87ad8bdccb8712
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYe2352870-3582-4d92-8712-87ad8bdccb8712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-6281-05009062810030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-6281-0) 2022-12-150000-00-00NoNoCurrent
50090-6281-15009062810190 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-6281-1) 2022-12-150000-00-00NoNoCurrent