Duloxetine

Product NDC
68001-257
11-digit product format
680010257
Labeler code
68001
Product ID
68001-257_c7179eef-e09a-2f0f-e053-2995a90a6309
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA090739
Marketing category
ANDA
Marketing start
2014-03-14
Marketing end
2021-11-30
Substance
DULOXETINE HYDROCHLORIDE
Active strength
60 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
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-257-04EA - Each68001-2578b0351a4-6370-44fe-9040-a8764957f25812014-07-02
68001-257-08EA - Each68001-257be5dd70f-564e-4d9d-acde-d5f5974dc26112017-03-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68001-257-046800102570430 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68001-257-04) 2014-03-140000-00-00NoNoCurrent
68001-257-08680010257081000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68001-257-08) 2017-01-310000-00-00NoNoCurrent