lubiprostone

Generic: lubiprostone

Labeler: natco pharma usa llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name lubiprostone
Generic Name lubiprostone
Labeler natco pharma usa llc
Dosage Form CAPSULE, GELATIN COATED
Routes
ORAL
Active Ingredients

lubiprostone 8 ug/1

Manufacturer
Natco Pharma USA LLC

Identifiers & Regulatory

Product NDC 69339-162
Product ID 69339-162_8eaefb22-646d-468c-9b62-a1c8585440e2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021908
Listing Expiration 2026-12-31
Marketing Start 2022-10-17

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 69339162
Hyphenated Format 69339-162

Supplemental Identifiers

RxCUI
616578 794639
UPC
0369339163177
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
  • 40 BLISTER PACK in 1 CARTON (69339-162-17) / 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK (69339-162-98)
source: ndc

Packages (1)

69339-162-17 40 BLISTER PACK in 1 CARTON (69339-162-17) / 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK (69339-162-98)

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": "8eaefb22-646d-468c-9b62-a1c8585440e2", "openfda": {"nui": ["N0000175573", "N0000175456"], "upc": ["0369339163177"], "unii": ["7662KG2R6K"], "rxcui": ["616578", "794639"], "spl_set_id": ["10c7b62d-6c39-453c-8d9a-2f441725bc3b"], "pharm_class_epc": ["Chloride Channel Activator [EPC]"], "pharm_class_moa": ["Chloride Channel Activators [MoA]"], "manufacturer_name": ["Natco Pharma USA LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "40 BLISTER PACK in 1 CARTON (69339-162-17)  / 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK (69339-162-98)", "package_ndc": "69339-162-17", "marketing_start_date": "20221017"}], "brand_name": "LUBIPROSTONE", "product_id": "69339-162_8eaefb22-646d-468c-9b62-a1c8585440e2", "dosage_form": "CAPSULE, GELATIN COATED", "pharm_class": ["Chloride Channel Activator [EPC]", "Chloride Channel Activators [MoA]"], "product_ndc": "69339-162", "generic_name": "LUBIPROSTONE", "labeler_name": "Natco Pharma USA LLC", "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": "20221017", "listing_expiration_date": "20261231"}