FDA.reportPublic FDA data

Duloxetine

Product NDC
50090-5940
11-digit product format
500905940
Labeler code
50090
Product ID
50090-5940_66bf0163-74cb-46b2-9189-8b26ef6d84b1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA208706
Marketing category
ANDA
Marketing start
2017-03-16
Substance
DULOXETINE HYDROCHLORIDE
Active strength
60 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 HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9044SC542W
Rxcui596934

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
aebfdb62-b550-4c4f-9225-d5d3bbc7ab88Product name920210727
7dd29e28-6b69-499b-9257-12a3b46ca283Product name120191120
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5940-0Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE303
50090-5940-1Duloxetine90 in 1 BOTTLECAPSULE, DELAYED RELEASE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5940-0EA - Each50090-59405b0a6556-b121-4f65-b00b-bdcb93cfa26212022-07-06
50090-5940-1EA - Each50090-5940d8ff8248-4dca-455c-b538-701fbcfebcb212022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5940DULOXETINE CAPSULE, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 2 package rows20231123_07a7dd8d-cbf8-4281-8583-d2d98711ed6c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596934DULoxetine 60 MG Delayed Release Oral CapsulePSN07a7dd8d-cbf8-4281-8583-d2d98711ed6c3
596934duloxetine 60 MG Delayed Release Oral CapsuleSCD07a7dd8d-cbf8-4281-8583-d2d98711ed6c3
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY07a7dd8d-cbf8-4281-8583-d2d98711ed6c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5940-05009059400030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-5940-0) 2022-03-140000-00-00NoNoCurrent
50090-5940-15009059400190 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-5940-1) 2022-03-140000-00-00NoNoCurrent