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United States · US · US:23635-524_8b815df4-ea84-46ca-9f53-fe89011d259e
Amitiza
Orange BookUNIISPLATC A06AX03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSpecGx LLC
CountryUS (United States)
ATC codeA06AX03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11236355246060 CAPSULE, GELATIN COATED in 1 BOTTLE (23635-524-60)
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": {
"164a2b47-0a52-4bb4-9e71-5342c2e951f4": {
"match": "brand_token",
"title": "AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [SPECGX LLC]",
"spl_version": "3",
"published_date": "2025-09-22"
}
},
"productid": "23635-524_8b815df4-ea84-46ca-9f53-fe89011d259e",
"productndc": "23635-524",
"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": "Amitiza",
"active_ingred_unit": "ug/1",
"application_number": "NDA021908",
"marketing_category": "NDA",
"nonproprietary_name": "lubiprostone",
"start_marketing_date": "20240401",
"active_numerator_strength": "24"
}Related drugs
Other records sharing ATC code A06AX03.
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