lubiprostone

Generic: lubiprostone

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lubiprostone
Generic Name lubiprostone
Labeler zydus pharmaceuticals usa inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

lubiprostone 8 ug/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 70710-1641
Product ID 70710-1641_f06e99fa-9894-48ab-99d8-914987dbb73f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214131
Listing Expiration 2026-12-31
Marketing Start 2023-03-23

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 707101641
Hyphenated Format 70710-1641

Supplemental Identifiers

RxCUI
616578 794639
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 ANDA214131 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 ug/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (70710-1641-1)
  • 60 CAPSULE in 1 BOTTLE (70710-1641-6)
source: ndc

Packages (2)

70710-1641-1 100 CAPSULE in 1 BOTTLE (70710-1641-1) 70710-1641-6 60 CAPSULE in 1 BOTTLE (70710-1641-6)

Ingredients (1)

lubiprostone (8 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": "f06e99fa-9894-48ab-99d8-914987dbb73f", "openfda": {"nui": ["N0000175573", "N0000175456"], "unii": ["7662KG2R6K"], "rxcui": ["616578", "794639"], "spl_set_id": ["6c11a204-6831-4269-a3c4-1702ed83f74b"], "pharm_class_epc": ["Chloride Channel Activator [EPC]"], "pharm_class_moa": ["Chloride Channel Activators [MoA]"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (70710-1641-1)", "package_ndc": "70710-1641-1", "marketing_start_date": "20230323"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (70710-1641-6)", "package_ndc": "70710-1641-6", "marketing_start_date": "20230323"}], "brand_name": "Lubiprostone", "product_id": "70710-1641_f06e99fa-9894-48ab-99d8-914987dbb73f", "dosage_form": "CAPSULE", "pharm_class": ["Chloride Channel Activator [EPC]", "Chloride Channel Activators [MoA]"], "product_ndc": "70710-1641", "generic_name": "Lubiprostone", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lubiprostone", "active_ingredients": [{"name": "LUBIPROSTONE", "strength": "8 ug/1"}], "application_number": "ANDA214131", "marketing_category": "ANDA", "marketing_start_date": "20230323", "listing_expiration_date": "20261231"}