DULOXETINE

Product NDC
48792-7896
11-digit product format
487927896
Labeler code
48792
Product ID
48792-7896_bbc151fd-32ab-5639-e053-2a95a90a3d0e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine hydrochloride
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Sunshine Lake Pharma Co., Ltd.
Application
ANDA212328
Marketing category
ANDA
Marketing start
2004-08-24
Marketing end
0000-00-00
Substance
DULOXETINE HYDROCHLORIDE
Active strength
30 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
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
48792-7896-14879278960130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (48792-7896-1) 2021-02-110000-00-00NoNoCurrent
48792-7896-24879278960290 CAPSULE, DELAYED RELEASE in 1 BOTTLE (48792-7896-2) 2021-02-110000-00-00NoNoCurrent