Duloxetine Hydrochloride

Product NDC
0904-6453
11-digit product format
009046453
Labeler code
0904
Product ID
0904-6453_6566e7d5-91c3-4a9d-9680-7e3c8f6eae87
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
2022-10-31
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
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
0904-6453-61EA - Each0904-6453fa7a4ba8-0057-4707-b753-966d9eda9e9d12016-02-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6453-6100904645361100 BLISTER PACK in 1 CARTON (0904-6453-61) > 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK100 blister pack2014-06-132022-10-31NoNoCurrent