lubiprostone

Generic: lubiprostone

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

Drug Facts

Product Profile

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

lubiprostone .008 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-403
Product ID 31722-403_5008a4ec-08c5-4d06-bac9-e7239620a07d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218640
Listing Expiration 2026-12-31
Marketing Start 2025-05-27

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 31722403
Hyphenated Format 31722-403

Supplemental Identifiers

RxCUI
616578 794639
UPC
0331722404600 0331722403603
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 (31722-403-60)
source: ndc

Packages (1)

31722-403-60 60 CAPSULE in 1 BOTTLE (31722-403-60)

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": "5008a4ec-08c5-4d06-bac9-e7239620a07d", "openfda": {"nui": ["N0000175573", "N0000175456"], "upc": ["0331722404600", "0331722403603"], "unii": ["7662KG2R6K"], "rxcui": ["616578", "794639"], "spl_set_id": ["6d973d7d-a43e-4495-b618-a8ad3142683d"], "pharm_class_epc": ["Chloride Channel Activator [EPC]"], "pharm_class_moa": ["Chloride Channel Activators [MoA]"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE (31722-403-60)", "package_ndc": "31722-403-60", "marketing_start_date": "20250527"}], "brand_name": "Lubiprostone", "product_id": "31722-403_5008a4ec-08c5-4d06-bac9-e7239620a07d", "dosage_form": "CAPSULE", "pharm_class": ["Chloride Channel Activator [EPC]", "Chloride Channel Activators [MoA]"], "product_ndc": "31722-403", "generic_name": "lubiprostone", "labeler_name": "Camber Pharmaceuticals, Inc.", "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": "20250527", "listing_expiration_date": "20261231"}