amitza

Generic: lubiprostone

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amitza
Generic Name lubiprostone
Labeler direct_rx
Dosage Form CAPSULE, GELATIN COATED
Routes
ORAL
Active Ingredients

lubiprostone 8 ug/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-410
Product ID 72189-410_2c4cfec2-fedf-e007-e063-6294a90a3cf9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209920
Listing Expiration 2026-12-31
Marketing Start 2023-01-12

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 72189410
Hyphenated Format 72189-410

Supplemental Identifiers

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 amitza (source: ndc)
Generic Name lubiprostone (source: ndc)
Application Number ANDA209920 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 ug/1
source: ndc
Packaging
  • 60 CAPSULE, GELATIN COATED in 1 BOTTLE (72189-410-60)
source: ndc

Packages (1)

72189-410-60 60 CAPSULE, GELATIN COATED in 1 BOTTLE (72189-410-60)

Ingredients (1)

lubiprostone (8 ug/1)

Linked Drug Pages (1)

Amitza ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2c4cfec2-fedf-e007-e063-6294a90a3cf9", "openfda": {"nui": ["N0000175573", "N0000175456"], "unii": ["7662KG2R6K"], "spl_set_id": ["f2121338-9586-161d-e053-2995a90af908"], "pharm_class_epc": ["Chloride Channel Activator [EPC]"], "pharm_class_moa": ["Chloride Channel Activators [MoA]"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE, GELATIN COATED in 1 BOTTLE (72189-410-60)", "package_ndc": "72189-410-60", "marketing_start_date": "20230112"}], "brand_name": "Amitza", "product_id": "72189-410_2c4cfec2-fedf-e007-e063-6294a90a3cf9", "dosage_form": "CAPSULE, GELATIN COATED", "pharm_class": ["Chloride Channel Activator [EPC]", "Chloride Channel Activators [MoA]"], "product_ndc": "72189-410", "generic_name": "Lubiprostone", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amitza", "active_ingredients": [{"name": "LUBIPROSTONE", "strength": "8 ug/1"}], "application_number": "ANDA209920", "marketing_category": "ANDA", "marketing_start_date": "20230112", "listing_expiration_date": "20261231"}