lubiprostone

Generic: lubiprostone

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

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

lubiprostone 8 ug/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-906
Product ID 76420-906_2cbe759e-e896-7ada-e063-6394a90a6cc5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021908
Listing Expiration 2026-12-31
Marketing Start 2023-01-01

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 76420906
Hyphenated Format 76420-906

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 NDA021908 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 ug/1
source: ndc
Packaging
  • 100 CAPSULE, GELATIN COATED in 1 BOTTLE (76420-906-01)
  • 30 CAPSULE, GELATIN COATED in 1 BOTTLE (76420-906-30)
  • 60 CAPSULE, GELATIN COATED in 1 BOTTLE (76420-906-60)
  • 90 CAPSULE, GELATIN COATED in 1 BOTTLE (76420-906-90)
source: ndc

Packages (4)

76420-906-01 100 CAPSULE, GELATIN COATED in 1 BOTTLE (76420-906-01) 76420-906-30 30 CAPSULE, GELATIN COATED in 1 BOTTLE (76420-906-30) 76420-906-60 60 CAPSULE, GELATIN COATED in 1 BOTTLE (76420-906-60) 76420-906-90 90 CAPSULE, GELATIN COATED in 1 BOTTLE (76420-906-90)

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": "2cbe759e-e896-7ada-e063-6394a90a6cc5", "openfda": {"nui": ["N0000175573", "N0000175456"], "unii": ["7662KG2R6K"], "rxcui": ["616578", "794639"], "spl_set_id": ["f5653f3b-c3c8-487c-bc00-3770985aa5ee"], "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, GELATIN COATED in 1 BOTTLE (76420-906-01)", "package_ndc": "76420-906-01", "marketing_start_date": "20250128"}, {"sample": false, "description": "30 CAPSULE, GELATIN COATED in 1 BOTTLE (76420-906-30)", "package_ndc": "76420-906-30", "marketing_start_date": "20250128"}, {"sample": false, "description": "60 CAPSULE, GELATIN COATED in 1 BOTTLE (76420-906-60)", "package_ndc": "76420-906-60", "marketing_start_date": "20250128"}, {"sample": false, "description": "90 CAPSULE, GELATIN COATED in 1 BOTTLE (76420-906-90)", "package_ndc": "76420-906-90", "marketing_start_date": "20250128"}], "brand_name": "Lubiprostone", "product_id": "76420-906_2cbe759e-e896-7ada-e063-6394a90a6cc5", "dosage_form": "CAPSULE, GELATIN COATED", "pharm_class": ["Chloride Channel Activator [EPC]", "Chloride Channel Activators [MoA]"], "product_ndc": "76420-906", "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": "NDA021908", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20230101", "listing_expiration_date": "20261231"}