lubiprostone

Generic: lubiprostone

Labeler: teva pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lubiprostone
Generic Name lubiprostone
Labeler teva pharmaceuticals, inc.
Dosage Form CAPSULE, GELATIN COATED
Routes
ORAL
Active Ingredients

lubiprostone 24 ug/1

Manufacturer
Teva Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0480-4138
Product ID 0480-4138_22f53da2-2fb9-411d-baad-fef011383f6f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209920
Listing Expiration 2026-12-31
Marketing Start 2023-01-03

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 04804138
Hyphenated Format 0480-4138

Supplemental Identifiers

RxCUI
616578 794639
UPC
0304804138069 0304803479064
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 ANDA209920 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 24 ug/1
source: ndc
Packaging
  • 60 CAPSULE, GELATIN COATED in 1 BOTTLE (0480-4138-06)
source: ndc

Packages (1)

0480-4138-06 60 CAPSULE, GELATIN COATED in 1 BOTTLE (0480-4138-06)

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": "22f53da2-2fb9-411d-baad-fef011383f6f", "openfda": {"nui": ["N0000175573", "N0000175456"], "upc": ["0304804138069", "0304803479064"], "unii": ["7662KG2R6K"], "rxcui": ["616578", "794639"], "spl_set_id": ["e17b521e-2c25-4bef-82f9-7916fa79bca4"], "pharm_class_epc": ["Chloride Channel Activator [EPC]"], "pharm_class_moa": ["Chloride Channel Activators [MoA]"], "manufacturer_name": ["Teva Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE, GELATIN COATED in 1 BOTTLE (0480-4138-06)", "package_ndc": "0480-4138-06", "marketing_start_date": "20230103"}], "brand_name": "Lubiprostone", "product_id": "0480-4138_22f53da2-2fb9-411d-baad-fef011383f6f", "dosage_form": "CAPSULE, GELATIN COATED", "pharm_class": ["Chloride Channel Activator [EPC]", "Chloride Channel Activators [MoA]"], "product_ndc": "0480-4138", "generic_name": "Lubiprostone", "labeler_name": "Teva Pharmaceuticals, Inc.", "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": "20230103", "listing_expiration_date": "20261231"}