lubiprostone

Generic: lubiprostone

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name lubiprostone
Generic Name lubiprostone
Labeler proficient rx lp
Dosage Form CAPSULE, GELATIN COATED
Routes
ORAL
Active Ingredients

lubiprostone 8 ug/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-831
Product ID 71205-831_4aed57d0-99d8-424e-a1c7-0cd8a31a66cf
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 71205831
Hyphenated Format 71205-831

Supplemental Identifiers

RxCUI
794639
UPC
0371205831301
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 (71205-831-00)
  • 1000 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-11)
  • 30 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-30)
  • 500 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-55)
  • 60 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-60)
  • 240 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-64)
  • 270 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-67)
  • 120 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-72)
  • 180 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-78)
  • 90 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-90)
source: ndc

Packages (10)

71205-831-00 100 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-00) 71205-831-11 1000 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-11) 71205-831-30 30 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-30) 71205-831-55 500 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-55) 71205-831-60 60 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-60) 71205-831-64 240 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-64) 71205-831-67 270 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-67) 71205-831-72 120 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-72) 71205-831-78 180 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-78) 71205-831-90 90 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-90)

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": "4aed57d0-99d8-424e-a1c7-0cd8a31a66cf", "openfda": {"nui": ["N0000175573", "N0000175456"], "upc": ["0371205831301"], "unii": ["7662KG2R6K"], "rxcui": ["794639"], "spl_set_id": ["4aed57d0-99d8-424e-a1c7-0cd8a31a66cf"], "pharm_class_epc": ["Chloride Channel Activator [EPC]"], "pharm_class_moa": ["Chloride Channel Activators [MoA]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-00)", "package_ndc": "71205-831-00", "marketing_start_date": "20231018"}, {"sample": false, "description": "1000 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-11)", "package_ndc": "71205-831-11", "marketing_start_date": "20231018"}, {"sample": false, "description": "30 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-30)", "package_ndc": "71205-831-30", "marketing_start_date": "20231018"}, {"sample": false, "description": "500 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-55)", "package_ndc": "71205-831-55", "marketing_start_date": "20231018"}, {"sample": false, "description": "60 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-60)", "package_ndc": "71205-831-60", "marketing_start_date": "20231018"}, {"sample": false, "description": "240 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-64)", "package_ndc": "71205-831-64", "marketing_start_date": "20231018"}, {"sample": false, "description": "270 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-67)", "package_ndc": "71205-831-67", "marketing_start_date": "20231018"}, {"sample": false, "description": "120 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-72)", "package_ndc": "71205-831-72", "marketing_start_date": "20231018"}, {"sample": false, "description": "180 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-78)", "package_ndc": "71205-831-78", "marketing_start_date": "20231018"}, {"sample": false, "description": "90 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-90)", "package_ndc": "71205-831-90", "marketing_start_date": "20231018"}], "brand_name": "Lubiprostone", "product_id": "71205-831_4aed57d0-99d8-424e-a1c7-0cd8a31a66cf", "dosage_form": "CAPSULE, GELATIN COATED", "pharm_class": ["Chloride Channel Activator [EPC]", "Chloride Channel Activators [MoA]"], "product_ndc": "71205-831", "generic_name": "lubiprostone", "labeler_name": "Proficient Rx LP", "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"}