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United States · US · US:76420-777_2d872107-0284-f85f-e063-6394a90a6258
Lubiprostone
Orange BookUNIISPLATC A06AX03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAsclemed USA, Inc.
CountryUS (United States)
ATC codeA06AX03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc117642077701100 CAPSULE in 1 BOTTLE (76420-777-01)
- ndc11764207773030 CAPSULE in 1 BOTTLE (76420-777-30)
- ndc11764207776060 CAPSULE in 1 BOTTLE (76420-777-60)
- ndc11764207779090 CAPSULE in 1 BOTTLE (76420-777-90)
Annotations
UNII (FDA Substance ID)
7662KG2R6K
LUBIPROSTONE
RxCUI 623033
Orange Book
A214131
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": "76420-777_2d872107-0284-f85f-e063-6394a90a6258",
"productndc": "76420-777",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "214131",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "8MCG",
"product_no": "001",
"approval_date": "Mar 23, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "24MCG",
"product_no": "002",
"approval_date": "Mar 23, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LUBIPROSTONE",
"proprietary_name": "Lubiprostone",
"active_ingred_unit": "ug/1",
"application_number": "ANDA214131",
"marketing_category": "ANDA",
"nonproprietary_name": "Lubiprostone",
"start_marketing_date": "20230323",
"active_numerator_strength": "8"
}Related drugs
Other records sharing ATC code A06AX03.
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