Duloxetine Hydrochloride

Product NDC
0904-6452
11-digit product format
009046452
Labeler code
0904
Product ID
0904-6452_82377a50-3f4a-41e7-a30e-e36d366e7d5b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine Hydrochloride
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA202045
Marketing category
ANDA
Marketing start
2014-06-13
Marketing end
2022-03-31
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
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
0904-6452-04EA - Each0904-645297c0c6fa-7d60-48ca-9311-3601cb09607312016-10-06
0904-6452-61EA - Each0904-64522115dc4e-da62-4bc9-9c8e-fde2e108206412016-01-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6452-040090464520430 BLISTER PACK in 1 CARTON (0904-6452-04) > 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK30 blister pack2014-06-132022-03-31NoNoCurrent
0904-6452-6100904645261100 BLISTER PACK in 1 CARTON (0904-6452-61) > 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK100 blister pack2014-06-132022-03-31NoNoCurrent