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United States · US · US:72189-410_2c4cfec2-fedf-e007-e063-6294a90a3cf9
Amitza
Orange BookUNIISPLATC A06AX03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDirect_Rx
CountryUS (United States)
ATC codeA06AX03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11721894106060 CAPSULE, GELATIN COATED in 1 BOTTLE (72189-410-60)
Annotations
UNII (FDA Substance ID)
7662KG2R6K
LUBIPROSTONE
RxCUI 623033
Orange Book
A209920
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": {
"f2121338-9586-161d-e053-2995a90af908": {
"match": "brand_token",
"title": "AMITZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [DIRECT_RX]",
"spl_version": "2",
"published_date": "2025-01-23"
}
},
"productid": "72189-410_2c4cfec2-fedf-e007-e063-6294a90a3cf9",
"productndc": "72189-410",
"dosage_form": "CAPSULE, GELATIN COATED",
"orange_book": {
"appl_no": "209920",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "8MCG",
"product_no": "001",
"approval_date": "Jan 18, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "24MCG",
"product_no": "002",
"approval_date": "Jan 18, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LUBIPROSTONE",
"proprietary_name": "Amitza",
"active_ingred_unit": "ug/1",
"application_number": "ANDA209920",
"marketing_category": "ANDA",
"nonproprietary_name": "Lubiprostone",
"start_marketing_date": "20230112",
"active_numerator_strength": "8"
}Related drugs
Other records sharing ATC code A06AX03.
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