lubiprostone

Generic: lubiprostone

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lubiprostone
Generic Name lubiprostone
Labeler asclemed usa, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

lubiprostone 8 ug/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-777
Product ID 76420-777_2d872107-0284-f85f-e063-6394a90a6258
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214131
Listing Expiration 2026-12-31
Marketing Start 2023-03-23

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 76420777
Hyphenated Format 76420-777

Supplemental Identifiers

RxCUI
616578 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 ANDA214131 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 ug/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (76420-777-01)
  • 30 CAPSULE in 1 BOTTLE (76420-777-30)
  • 60 CAPSULE in 1 BOTTLE (76420-777-60)
  • 90 CAPSULE in 1 BOTTLE (76420-777-90)
source: ndc

Packages (4)

76420-777-01 100 CAPSULE in 1 BOTTLE (76420-777-01) 76420-777-30 30 CAPSULE in 1 BOTTLE (76420-777-30) 76420-777-60 60 CAPSULE in 1 BOTTLE (76420-777-60) 76420-777-90 90 CAPSULE in 1 BOTTLE (76420-777-90)

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": "2d872107-0284-f85f-e063-6394a90a6258", "openfda": {"nui": ["N0000175573", "N0000175456"], "unii": ["7662KG2R6K"], "rxcui": ["616578", "794639"], "spl_set_id": ["5797e57c-4e87-48d9-b16d-992f64db594f"], "pharm_class_epc": ["Chloride Channel Activator [EPC]"], "pharm_class_moa": ["Chloride Channel Activators [MoA]"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (76420-777-01)", "package_ndc": "76420-777-01", "marketing_start_date": "20250207"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (76420-777-30)", "package_ndc": "76420-777-30", "marketing_start_date": "20250207"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (76420-777-60)", "package_ndc": "76420-777-60", "marketing_start_date": "20250207"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (76420-777-90)", "package_ndc": "76420-777-90", "marketing_start_date": "20250207"}], "brand_name": "Lubiprostone", "product_id": "76420-777_2d872107-0284-f85f-e063-6394a90a6258", "dosage_form": "CAPSULE", "pharm_class": ["Chloride Channel Activator [EPC]", "Chloride Channel Activators [MoA]"], "product_ndc": "76420-777", "generic_name": "Lubiprostone", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lubiprostone", "active_ingredients": [{"name": "LUBIPROSTONE", "strength": "8 ug/1"}], "application_number": "ANDA214131", "marketing_category": "ANDA", "marketing_start_date": "20230323", "listing_expiration_date": "20261231"}