amitiza

Generic: lubiprostone

Labeler: specgx llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name amitiza
Generic Name lubiprostone
Labeler specgx llc
Dosage Form CAPSULE, GELATIN COATED
Routes
ORAL
Active Ingredients

lubiprostone 24 ug/1

Manufacturer
SpecGx LLC

Identifiers & Regulatory

Product NDC 23635-524
Product ID 23635-524_8b815df4-ea84-46ca-9f53-fe89011d259e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021908
Listing Expiration 2026-12-31
Marketing Start 2024-04-01

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 23635524
Hyphenated Format 23635-524

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 (23635-524-60)
source: ndc

Packages (1)

23635-524-60 60 CAPSULE, GELATIN COATED in 1 BOTTLE (23635-524-60)

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": "8b815df4-ea84-46ca-9f53-fe89011d259e", "openfda": {"nui": ["N0000175573", "N0000175456"], "unii": ["7662KG2R6K"], "rxcui": ["616578", "617768", "794639", "794641"], "spl_set_id": ["164a2b47-0a52-4bb4-9e71-5342c2e951f4"], "pharm_class_epc": ["Chloride Channel Activator [EPC]"], "pharm_class_moa": ["Chloride Channel Activators [MoA]"], "manufacturer_name": ["SpecGx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE, GELATIN COATED in 1 BOTTLE (23635-524-60)", "package_ndc": "23635-524-60", "marketing_start_date": "20240401"}], "brand_name": "Amitiza", "product_id": "23635-524_8b815df4-ea84-46ca-9f53-fe89011d259e", "dosage_form": "CAPSULE, GELATIN COATED", "pharm_class": ["Chloride Channel Activator [EPC]", "Chloride Channel Activators [MoA]"], "product_ndc": "23635-524", "generic_name": "lubiprostone", "labeler_name": "SpecGx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amitiza", "active_ingredients": [{"name": "LUBIPROSTONE", "strength": "24 ug/1"}], "application_number": "NDA021908", "marketing_category": "NDA", "marketing_start_date": "20240401", "listing_expiration_date": "20261231"}