lubiprostone

Generic: lubiprostone

Labeler: quality care products, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name lubiprostone
Generic Name lubiprostone
Labeler quality care products, llc
Dosage Form CAPSULE, GELATIN COATED
Routes
ORAL
Active Ingredients

lubiprostone 24 ug/1

Manufacturer
Quality Care Products, LLC

Identifiers & Regulatory

Product NDC 83008-001
Product ID 83008-001_fd3c99bd-7841-472f-bb74-abe1dc15ee8a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021908
Marketing Start 2023-03-14
Marketing End 2026-08-31

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 83008001
Hyphenated Format 83008-001

Supplemental Identifiers

RxCUI
616578
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
  • 60 CAPSULE, GELATIN COATED in 1 BOTTLE (83008-001-60)
source: ndc

Packages (1)

83008-001-60 60 CAPSULE, GELATIN COATED in 1 BOTTLE (83008-001-60)

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": "fd3c99bd-7841-472f-bb74-abe1dc15ee8a", "openfda": {"nui": ["N0000175573", "N0000175456"], "unii": ["7662KG2R6K"], "rxcui": ["616578"], "spl_set_id": ["9bffe7c4-40f2-4490-a32f-15d525000928"], "pharm_class_epc": ["Chloride Channel Activator [EPC]"], "pharm_class_moa": ["Chloride Channel Activators [MoA]"], "manufacturer_name": ["Quality Care Products, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE, GELATIN COATED in 1 BOTTLE (83008-001-60)", "package_ndc": "83008-001-60", "marketing_end_date": "20260831", "marketing_start_date": "20230314"}], "brand_name": "Lubiprostone", "product_id": "83008-001_fd3c99bd-7841-472f-bb74-abe1dc15ee8a", "dosage_form": "CAPSULE, GELATIN COATED", "pharm_class": ["Chloride Channel Activator [EPC]", "Chloride Channel Activators [MoA]"], "product_ndc": "83008-001", "generic_name": "lubiprostone", "labeler_name": "Quality Care Products, LLC", "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_end_date": "20260831", "marketing_start_date": "20230314"}