NDC 72189-410

Amitza

Lubiprostone

Amitza is a Oral Capsule, Gelatin Coated in the Human Prescription Drug category. It is labeled and distributed by Direct_rx. The primary component is Lubiprostone.

Product ID72189-410_f2121338-9587-161d-e053-2995a90af908
NDC72189-410
Product TypeHuman Prescription Drug
Proprietary NameAmitza
Generic NameLubiprostone
Dosage FormCapsule, Gelatin Coated
Route of AdministrationORAL
Marketing Start Date2023-01-12
Marketing CategoryANDA /
Application NumberANDA209920
Labeler NameDirect_Rx
Substance NameLUBIPROSTONE
Active Ingredient Strength8 ug/1
Pharm ClassesChloride Channel Activator [EPC], Chloride Channel Activators [MoA]
NDC Exclude FlagN
Listing Certified Through2024-12-31

Packaging

NDC 72189-410-60

60 CAPSULE, GELATIN COATED in 1 BOTTLE (72189-410-60)
Marketing Start Date2023-01-12
NDC Exclude FlagN
Sample Package?N

Drug Details

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

NDCBrand NameGeneric Name
72189-410AmitzaLubiprostone
35356-500Amitizalubiprostone
63629-6398Amitizalubiprostone
64764-080Amitizalubiprostone
64764-240Amitizalubiprostone
68151-5003Amitizalubiprostone
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

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