NDC 25000-610

Duloxetine

Duloxetine Hydrochloride

Duloxetine is a Oral Capsule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Marksans Pharma Limited. The primary component is Duloxetine Hydrochloride.

Product ID25000-610_922e6be8-2bd2-464c-8bf5-a208c9201cb1
NDC25000-610
Product TypeHuman Prescription Drug
Proprietary NameDuloxetine
Generic NameDuloxetine Hydrochloride
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2022-05-27
Marketing CategoryANDA /
Application NumberANDA090723
Labeler NameMARKSANS PHARMA LIMITED
Substance NameDULOXETINE HYDROCHLORIDE
Active Ingredient Strength60 mg/1
Pharm ClassesNorepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 25000-610-03

30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (25000-610-03)
Marketing Start Date2022-05-27
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Duloxetine" or generic name "Duloxetine Hydrochloride"

NDCBrand NameGeneric Name
0093-7542DuloxetineDuloxetine
0093-7543DuloxetineDuloxetine
0093-7544DuloxetineDuloxetine
0228-2890DuloxetineDuloxetine
0228-2891DuloxetineDuloxetine
0228-2892DuloxetineDuloxetine
67877-264DuloxetineDuloxetine
67877-265DuloxetineDuloxetine
67877-263DuloxetineDuloxetine
68001-255DuloxetineDuloxetine
68001-256DuloxetineDuloxetine
68001-257DuloxetineDuloxetine
68071-4700DuloxetineDuloxetine
68084-692DuloxetineDuloxetine
68084-675DuloxetineDuloxetine
68084-683DuloxetineDuloxetine
68151-4727DuloxetineDuloxetine
68180-294DuloxetineDuloxetine
68180-297DuloxetineDuloxetine
68180-295DuloxetineDuloxetine
68180-296DuloxetineDuloxetine
68382-385DuloxetineDuloxetine
68382-386DuloxetineDuloxetine
68382-387DuloxetineDuloxetine
68788-6427duloxetineduloxetine
68788-9262DuloxetineDuloxetine
68788-9266DuloxetineDuloxetine
69097-298duloxetineduloxetine
69097-297duloxetineduloxetine
69097-299duloxetineduloxetine
70518-0491DuloxetineDuloxetine
70518-1066DuloxetineDuloxetine
70518-0937DuloxetineDuloxetine
70518-1054DuloxetineDuloxetine
70518-1139DuloxetineDuloxetine
70518-0685DuloxetineDuloxetine
70518-1128DULOXETINEDULOXETINE
70518-1011DuloxetineDuloxetine
70518-1244DuloxetineDuloxetine
70518-1137DuloxetineDuloxetine
70518-1765DuloxetineDuloxetine
70710-1537DuloxetineDuloxetine
70518-1891DuloxetineDuloxetine
70710-1538DuloxetineDuloxetine
70771-1344DuloxetineDuloxetine
70710-1539DuloxetineDuloxetine
70771-1346DuloxetineDuloxetine
70771-1345DuloxetineDuloxetine
71205-005DuloxetineDuloxetine
71335-0367DuloxetineDuloxetine
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.