FDA.reportPublic FDA data

Duloxetine

Product NDC
50090-6040
11-digit product format
500906040
Labeler code
50090
Product ID
50090-6040_0ec425f3-4d89-421d-8d49-8fb1ce38c8ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204343
Marketing category
ANDA
Marketing start
2016-08-11
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-6040-02024-01-30C16284748780-11030e365-382d-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DULOXETINE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for DULOXETINE DELAYED-RELEASE CAPSULES. DULOXETINE delayed-release capsules, for Oral Use. Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6040-0Duloxetine33 in 1 BOXCAPSULE, DELAYED RELEASE334
50090-6040-0Duloxetine1 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6040-0EA - Each50090-6040cfb2b877-bf2c-4533-9391-0efb8962223112023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6040DULOXETINE CAPSULE, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]4Legacy NDC, 2 package rows20220717_0ba5b758-5dd4-4d65-9952-1f80ae9d195e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN0ba5b758-5dd4-4d65-9952-1f80ae9d195e4
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD0ba5b758-5dd4-4d65-9952-1f80ae9d195e4
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY0ba5b758-5dd4-4d65-9952-1f80ae9d195e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-6040-05009060400033 BLISTER PACK in 1 BOX (50090-6040-0) > 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK33 blister pack2022-07-130000-00-00NoNoCurrent