lubiprostone

Generic: lubiprostone

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lubiprostone
Generic Name lubiprostone
Labeler american health packaging
Dosage Form CAPSULE, GELATIN COATED
Routes
ORAL
Active Ingredients

lubiprostone 24 ug/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-827
Product ID 60687-827_48604627-792c-1889-e063-6294a90ab1b5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209920
Listing Expiration 2027-12-31
Marketing Start 2025-11-26

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 60687827
Hyphenated Format 60687-827

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 ANDA209920 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 24 ug/1
source: ndc
Packaging
  • 20 BLISTER PACK in 1 CARTON (60687-827-32) / 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK (60687-827-33)
source: ndc

Packages (1)

60687-827-32 20 BLISTER PACK in 1 CARTON (60687-827-32) / 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK (60687-827-33)

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": "48604627-792c-1889-e063-6294a90ab1b5", "openfda": {"nui": ["N0000175573", "N0000175456"], "unii": ["7662KG2R6K"], "rxcui": ["616578", "794639"], "spl_set_id": ["3014dd6d-9c05-479d-b79d-7a49f78a1ce5"], "pharm_class_epc": ["Chloride Channel Activator [EPC]"], "pharm_class_moa": ["Chloride Channel Activators [MoA]"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "20 BLISTER PACK in 1 CARTON (60687-827-32)  / 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK (60687-827-33)", "package_ndc": "60687-827-32", "marketing_start_date": "20251126"}], "brand_name": "Lubiprostone", "product_id": "60687-827_48604627-792c-1889-e063-6294a90ab1b5", "dosage_form": "CAPSULE, GELATIN COATED", "pharm_class": ["Chloride Channel Activator [EPC]", "Chloride Channel Activators [MoA]"], "product_ndc": "60687-827", "generic_name": "Lubiprostone", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lubiprostone", "active_ingredients": [{"name": "LUBIPROSTONE", "strength": "24 ug/1"}], "application_number": "ANDA209920", "marketing_category": "ANDA", "marketing_start_date": "20251126", "listing_expiration_date": "20271231"}