lubiprostone

Generic: lubiprostone

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name lubiprostone
Generic Name lubiprostone
Labeler advanced rx of tennessee, llc
Dosage Form CAPSULE, GELATIN COATED
Routes
ORAL
Active Ingredients

lubiprostone 8 ug/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0354
Product ID 80425-0354_2a99a670-af29-299d-e063-6294a90a05d2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021908
Listing Expiration 2026-12-31
Marketing Start 2023-08-16

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 804250354
Hyphenated Format 80425-0354

Supplemental Identifiers

RxCUI
794639
UNII
7662KG2R6K
NUI
N0000175573 N0000175456

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

Resolved Composition

Strengths
  • 8 ug/1
source: ndc
Packaging
  • 60 CAPSULE, GELATIN COATED in 1 BOTTLE (80425-0354-2)
source: ndc

Packages (1)

80425-0354-2 60 CAPSULE, GELATIN COATED in 1 BOTTLE (80425-0354-2)

Ingredients (1)

lubiprostone (8 ug/1)

Linked Drug Pages (1)

Lubiprostone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2a99a670-af29-299d-e063-6294a90a05d2", "openfda": {"nui": ["N0000175573", "N0000175456"], "unii": ["7662KG2R6K"], "rxcui": ["794639"], "spl_set_id": ["031170a4-5f7d-b371-e063-6394a90ae21d"], "pharm_class_epc": ["Chloride Channel Activator [EPC]"], "pharm_class_moa": ["Chloride Channel Activators [MoA]"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE, GELATIN COATED in 1 BOTTLE (80425-0354-2)", "package_ndc": "80425-0354-2", "marketing_start_date": "20230816"}], "brand_name": "Lubiprostone", "product_id": "80425-0354_2a99a670-af29-299d-e063-6294a90a05d2", "dosage_form": "CAPSULE, GELATIN COATED", "pharm_class": ["Chloride Channel Activator [EPC]", "Chloride Channel Activators [MoA]"], "product_ndc": "80425-0354", "generic_name": "lubiprostone", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lubiprostone", "active_ingredients": [{"name": "LUBIPROSTONE", "strength": "8 ug/1"}], "application_number": "NDA021908", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20230816", "listing_expiration_date": "20261231"}