NDC 65162-841

Lubiprostone

Lubiprostone

Lubiprostone is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Llc. The primary component is Lubiprostone.

Product ID65162-841_46db0194-b960-401e-a885-ccb545b72f51
NDC65162-841
Product TypeHuman Prescription Drug
Proprietary NameLubiprostone
Generic NameLubiprostone
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2021-12-03
Marketing CategoryANDA /
Application NumberANDA209450
Labeler NameAmneal Pharmaceuticals LLC
Substance NameLUBIPROSTONE
Active Ingredient Strength8 ug/1
Pharm ClassesChloride Channel Activator [EPC], Chloride Channel Activators [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 65162-841-06

60 CAPSULE in 1 BOTTLE (65162-841-06)
Marketing Start Date2021-12-03
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Lubiprostone" or generic name "Lubiprostone"

NDCBrand NameGeneric Name
0254-3028LubiprostoneLubiprostone
0254-3029LubiprostoneLubiprostone
0480-3479LubiprostoneLubiprostone
0480-4138LubiprostoneLubiprostone
10370-266LubiprostoneLubiprostone
10370-267LubiprostoneLubiprostone
42291-475LubiprostoneLubiprostone
42291-476LubiprostoneLubiprostone
43598-163LubiprostoneLubiprostone
43598-168LubiprostoneLubiprostone
55700-963LubiprostoneLubiprostone
63304-351Lubiprostonelubiprostone
63304-352Lubiprostonelubiprostone
65162-841LubiprostoneLubiprostone
65162-842LubiprostoneLubiprostone
69339-162LUBIPROSTONELUBIPROSTONE
69339-163LUBIPROSTONELUBIPROSTONE
35356-500Amitizalubiprostone
63629-6398Amitizalubiprostone
64764-080Amitizalubiprostone
64764-240Amitizalubiprostone
68151-5003Amitizalubiprostone
72189-410AmitzaLubiprostone

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.