amitiza

Generic: lubiprostone

Labeler: takeda pharmaceuticals america, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name amitiza
Generic Name lubiprostone
Labeler takeda pharmaceuticals america, inc.
Dosage Form CAPSULE, GELATIN COATED
Routes
ORAL
Active Ingredients

lubiprostone 24 ug/1

Manufacturer
Takeda Pharmaceuticals America, Inc.

Identifiers & Regulatory

Product NDC 64764-240
Product ID 64764-240_c2ca8178-4da1-42d1-a8b9-ff66dca82649
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021908
Marketing Start 2006-01-31
Marketing End 2027-03-31

Pharmacologic Class

Established (EPC)
chloride channel activator [epc]
Mechanism of Action
chloride channel activators [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64764240
Hyphenated Format 64764-240

Supplemental Identifiers

RxCUI
616578 617768 794639 794641
UNII
7662KG2R6K
NUI
N0000175573 N0000175456

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name amitiza (source: ndc)
Generic Name lubiprostone (source: ndc)
Application Number NDA021908 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 24 ug/1
source: ndc
Packaging
  • 60 CAPSULE, GELATIN COATED in 1 BOTTLE (64764-240-60)
source: ndc

Packages (1)

64764-240-60 60 CAPSULE, GELATIN COATED in 1 BOTTLE (64764-240-60)

Ingredients (1)

lubiprostone (24 ug/1)

Linked Drug Pages (1)

Amitiza ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c2ca8178-4da1-42d1-a8b9-ff66dca82649", "openfda": {"nui": ["N0000175573", "N0000175456"], "unii": ["7662KG2R6K"], "rxcui": ["616578", "617768", "794639", "794641"], "spl_set_id": ["d474ac6a-444d-4aa6-9986-24be6fcf811d"], "pharm_class_epc": ["Chloride Channel Activator [EPC]"], "pharm_class_moa": ["Chloride Channel Activators [MoA]"], "manufacturer_name": ["Takeda Pharmaceuticals America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE, GELATIN COATED in 1 BOTTLE (64764-240-60)", "package_ndc": "64764-240-60", "marketing_end_date": "20270331", "marketing_start_date": "20060131"}], "brand_name": "Amitiza", "product_id": "64764-240_c2ca8178-4da1-42d1-a8b9-ff66dca82649", "dosage_form": "CAPSULE, GELATIN COATED", "pharm_class": ["Chloride Channel Activator [EPC]", "Chloride Channel Activators [MoA]"], "product_ndc": "64764-240", "generic_name": "lubiprostone", "labeler_name": "Takeda Pharmaceuticals America, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amitiza", "active_ingredients": [{"name": "LUBIPROSTONE", "strength": "24 ug/1"}], "application_number": "NDA021908", "marketing_category": "NDA", "marketing_end_date": "20270331", "marketing_start_date": "20060131"}