duloxetine

Product NDC
80175-0582
11-digit product format
801750582
Labeler code
80175
Product ID
80175-0582_be5f0570-6b1d-fc05-e053-2a95a90a9c43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Central Packaging
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 and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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
80175-0582-3duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80175-0582DULOXETINE CAPSULE, DELAYED RELEASE [CENTRAL PACKAGING]2Legacy NDC, 1 package rows20210310_bcd11524-8111-5c7f-e053-2995a90a457a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNbcd11524-8111-5c7f-e053-2995a90a457a2
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDbcd11524-8111-5c7f-e053-2995a90a457a2
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYbcd11524-8111-5c7f-e053-2995a90a457a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80175-0582-38017505820330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80175-0582-3) 2016-08-110000-00-00NoNoCurrent