NDC 64764-080

Amitiza

Lubiprostone

Amitiza is a Oral Capsule, Gelatin Coated in the Human Prescription Drug category. It is labeled and distributed by Takeda Pharmaceuticals America, Inc.. The primary component is Lubiprostone.

• Product ID: 64764-080_13cd7c3a-6e60-4f2d-a588-eb452fc711d0
• NDC: 64764-080
• Product Type: Human Prescription Drug
• Proprietary Name: Amitiza
• Generic Name: Lubiprostone
• Dosage Form: Capsule, Gelatin Coated
• Route of Administration: ORAL
• Marketing Start Date: 2006-01-31
• Marketing Category: NDA / NDA
• Application Number: NDA021908
• Labeler Name: Takeda Pharmaceuticals America, Inc.
• Substance Name: LUBIPROSTONE
• Active Ingredient Strength: 8 ug/1
• Pharm Classes: Chloride Channel Activator [EPC],Chloride Channel Activators [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 64764-080-60

60 CAPSULE, GELATIN COATED in 1 BOTTLE (64764-080-60)

• Marketing Start Date: 2006-01-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 64764-080-60 [64764008060]

Amitiza CAPSULE, GELATIN COATED

• Marketing Category: NDA
• Application Number: NDA021908
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2006-01-31

Drug Details

Active Ingredients

Ingredient	Strength
LUBIPROSTONE	8 ug/1

OpenFDA Data

• SPL SET ID: d474ac6a-444d-4aa6-9986-24be6fcf811d
• Manufacturer:
  • Takeda Pharmaceuticals America, Inc.
• UNII:
  • 7662KG2R6K
• RxNorm Concept Unique ID - RxCUI:
  • 616578
  • 794639
  • 617768
  • 794641
• UPC Code:
  • 0364764240608

Pharmacological Class

• Chloride Channel Activator [EPC]
• Chloride Channel Activators [MoA]

Medicade Reported Pricing

64764080530 ROZEREM 8 MG TABLET

Pricing Unit: EA | Drug Type:

64764080510 ROZEREM 8 MG TABLET

Pricing Unit: EA | Drug Type:

64764008060 AMITIZA 8 MCG CAPSULE

Pricing Unit: EA | Drug Type:

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

NDC	Brand Name	Generic Name
35356-500	Amitiza	lubiprostone
63629-6398	Amitiza	lubiprostone
64764-080	Amitiza	lubiprostone
64764-240	Amitiza	lubiprostone
68151-5003	Amitiza	lubiprostone
72189-410	Amitza	Lubiprostone
0254-3028	Lubiprostone	Lubiprostone
0254-3029	Lubiprostone	Lubiprostone
0480-3479	Lubiprostone	Lubiprostone
0480-4138	Lubiprostone	Lubiprostone
10370-266	Lubiprostone	Lubiprostone
10370-267	Lubiprostone	Lubiprostone
42291-475	Lubiprostone	Lubiprostone
42291-476	Lubiprostone	Lubiprostone
43598-163	Lubiprostone	Lubiprostone
43598-168	Lubiprostone	Lubiprostone
55700-963	Lubiprostone	Lubiprostone
63304-351	Lubiprostone	lubiprostone
63304-352	Lubiprostone	lubiprostone
65162-841	Lubiprostone	Lubiprostone
65162-842	Lubiprostone	Lubiprostone
69339-162	LUBIPROSTONE	LUBIPROSTONE
69339-163	LUBIPROSTONE	LUBIPROSTONE