Duloxetine hydrochloride

Product NDC
0615-8290
11-digit product format
006158290
Labeler code
0615
Product ID
0615-8290_f89d6671-190a-488d-81f9-98c5cddcaa7c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetin hydrochloride
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA090774
Marketing category
ANDA
Marketing start
2013-12-11
Marketing end
0000-00-00
Substance
DULOXETINE HYDROCHLORIDE
Active strength
20 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
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0615-8290-390061582903930 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8290-39) 2019-06-100000-00-00NoNoCurrent