Duloxetine hydrochloride

Product NDC
70518-0363
11-digit product format
705180363
Labeler code
70518
Product ID
70518-0363_7f9a0062-0e89-1deb-e053-2a91aa0a9188
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetin hydrochloride
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090774
Marketing category
ANDA
Marketing start
2017-03-24
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record