FDA.reportPublic FDA data

Duloxetine

Product NDC
50090-6406
11-digit product format
500906406
Labeler code
50090
Product ID
50090-6406_eaec6517-6ac0-4432-bbb6-9b3c70e7a1d9
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
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
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 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
50090-6406-0Duloxetine90 in 1 BOTTLECAPSULE, DELAYED RELEASE9013
50090-6406-1Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE3013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6406-0EA - Each50090-6406c4a31b43-fd2e-4eae-a5e9-bb21c8ce228512023-05-05
50090-6406-1EA - Each50090-640666908596-3a5a-4365-b1f3-d79125b9754c12023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6406DULOXETINE CAPSULE, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]13Current NDC, 2 package rows20240612_2be9e5fb-011e-424b-b504-df2a28b5271d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN2be9e5fb-011e-424b-b504-df2a28b5271d13
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD2be9e5fb-011e-424b-b504-df2a28b5271d13
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY2be9e5fb-011e-424b-b504-df2a28b5271d13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6406-05009064060090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-6406-0) 2023-03-23NoNoCurrent
50090-6406-15009064060130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-6406-1) 2023-07-24NoNoCurrent