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United States · US · US:80425-0355_2a999573-102f-813a-e063-6294a90a49b1
Lubiprostone
Orange BookUNIISPLATC A06AX03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAdvanced Rx of Tennessee, LLC
CountryUS (United States)
ATC codeA06AX03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11804250355260 CAPSULE, GELATIN COATED in 1 BOTTLE (80425-0355-2)
Annotations
UNII (FDA Substance ID)
7662KG2R6K
LUBIPROSTONE
RxCUI 623033
Orange Book
N021908
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "7662KG2R6K",
"rxcui": "623033",
"inchikey": "WGFOBBZOWHGYQH-MXHNKVEKSA-N",
"display_name": "LUBIPROSTONE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"f4d506e0-1322-4fc4-e053-2995a90ac880": {
"match": "brand_token",
"title": "LUBIPROSTONE CAPSULE, GELATIN COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]",
"spl_version": "5",
"published_date": "2026-05-11"
}
},
"productid": "80425-0355_2a999573-102f-813a-e063-6294a90a49b1",
"productndc": "80425-0355",
"dosage_form": "CAPSULE, GELATIN COATED",
"orange_book": {
"appl_no": "021908",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "24MCG",
"product_no": "001",
"approval_date": "Jan 31, 2006"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "8MCG",
"product_no": "002",
"approval_date": "Apr 29, 2008"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LUBIPROSTONE",
"proprietary_name": "Lubiprostone",
"active_ingred_unit": "ug/1",
"application_number": "NDA021908",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "lubiprostone",
"start_marketing_date": "20230816",
"active_numerator_strength": "24"
}Related drugs
Other records sharing ATC code A06AX03.
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