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 24 ug/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-001
Product ID 82804-001_34c547c4-4c29-45a9-97c7-a828bf2ecde0
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 82804001
Hyphenated Format 82804-001

Supplemental Identifiers

RxCUI
616578
UPC
0382804001606
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
  • 24 ug/1
source: ndc
Packaging
  • 30 CAPSULE, GELATIN COATED in 1 BOTTLE (82804-001-30)
  • 60 CAPSULE, GELATIN COATED in 1 BOTTLE (82804-001-60)
  • 90 CAPSULE, GELATIN COATED in 1 BOTTLE (82804-001-90)
source: ndc

Packages (3)

82804-001-30 30 CAPSULE, GELATIN COATED in 1 BOTTLE (82804-001-30) 82804-001-60 60 CAPSULE, GELATIN COATED in 1 BOTTLE (82804-001-60) 82804-001-90 90 CAPSULE, GELATIN COATED in 1 BOTTLE (82804-001-90)

Ingredients (1)

lubiprostone (24 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": "34c547c4-4c29-45a9-97c7-a828bf2ecde0", "openfda": {"nui": ["N0000175573", "N0000175456"], "upc": ["0382804001606"], "unii": ["7662KG2R6K"], "rxcui": ["616578"], "spl_set_id": ["34c547c4-4c29-45a9-97c7-a828bf2ecde0"], "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": "30 CAPSULE, GELATIN COATED in 1 BOTTLE (82804-001-30)", "package_ndc": "82804-001-30", "marketing_start_date": "20230824"}, {"sample": false, "description": "60 CAPSULE, GELATIN COATED in 1 BOTTLE (82804-001-60)", "package_ndc": "82804-001-60", "marketing_start_date": "20230824"}, {"sample": false, "description": "90 CAPSULE, GELATIN COATED in 1 BOTTLE (82804-001-90)", "package_ndc": "82804-001-90", "marketing_start_date": "20230824"}], "brand_name": "Lubiprostone", "product_id": "82804-001_34c547c4-4c29-45a9-97c7-a828bf2ecde0", "dosage_form": "CAPSULE, GELATIN COATED", "pharm_class": ["Chloride Channel Activator [EPC]", "Chloride Channel Activators [MoA]"], "product_ndc": "82804-001", "generic_name": "Lubiprostone", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lubiprostone", "active_ingredients": [{"name": "LUBIPROSTONE", "strength": "24 ug/1"}], "application_number": "NDA021908", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20230101", "listing_expiration_date": "20261231"}