DULOXETINE

Product NDC
43353-106
11-digit product format
433530106
Labeler code
43353
Product ID
43353-106_7431f3dd-bf89-4f5a-a9be-7118b0afbac9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DULOXETINE HYDROCHLORIDE
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA203088
Marketing category
ANDA
Marketing start
2014-06-11
Marketing end
0000-00-00
Substance
DULOXETINE HYDROCHLORIDE
Active strength
20 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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-106-16EA - Each43353-106d4c93b30-8f4b-453b-a2b9-b7605d4e36e312024-05-16
43353-106-33EA - Each43353-106bd4d50d7-c5c1-4148-8e18-e1fd32b600d112024-06-10
43353-106-83EA - Each43353-1065a13b85f-b535-4dd0-98a1-42233e59895212016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-106DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]7Legacy NDC20240410_c94339ab-3aaf-4cc9-b770-650b433bcce8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-106-83433530106833600 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (43353-106-83) 2015-10-130000-00-00NoNoCurrent