lubiprostone

Generic: lubiprostone

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lubiprostone
Generic Name lubiprostone
Labeler northstar rx llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

lubiprostone .008 mg/1

Manufacturer
Northstar Rx LLC

Identifiers & Regulatory

Product NDC 72603-288
Product ID 72603-288_4d72c56c-4948-4cd4-afc4-e1e0d59622a5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218640
Listing Expiration 2026-12-31
Marketing Start 2025-07-01

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 72603288
Hyphenated Format 72603-288

Supplemental Identifiers

RxCUI
616578 794639
UPC
0372603289015 0372603288018
UNII
7662KG2R6K
NUI
N0000175573 N0000175456

Packaging Origin

Original Packager
true

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 ANDA218640 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .008 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE (72603-288-01)
source: ndc

Packages (1)

72603-288-01 60 CAPSULE in 1 BOTTLE (72603-288-01)

Ingredients (1)

lubiprostone (.008 mg/1)

Linked Drug Pages (1)

Lubiprostone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4d72c56c-4948-4cd4-afc4-e1e0d59622a5", "openfda": {"nui": ["N0000175573", "N0000175456"], "upc": ["0372603289015", "0372603288018"], "unii": ["7662KG2R6K"], "rxcui": ["616578", "794639"], "spl_set_id": ["1626ac65-ea12-421b-9780-bfdb50a39e1a"], "pharm_class_epc": ["Chloride Channel Activator [EPC]"], "pharm_class_moa": ["Chloride Channel Activators [MoA]"], "manufacturer_name": ["Northstar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE (72603-288-01)", "package_ndc": "72603-288-01", "marketing_start_date": "20250701"}], "brand_name": "Lubiprostone", "product_id": "72603-288_4d72c56c-4948-4cd4-afc4-e1e0d59622a5", "dosage_form": "CAPSULE", "pharm_class": ["Chloride Channel Activator [EPC]", "Chloride Channel Activators [MoA]"], "product_ndc": "72603-288", "generic_name": "lubiprostone", "labeler_name": "Northstar Rx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lubiprostone", "active_ingredients": [{"name": "LUBIPROSTONE", "strength": ".008 mg/1"}], "application_number": "ANDA218640", "marketing_category": "ANDA", "marketing_start_date": "20250701", "listing_expiration_date": "20261231"}