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United States · US · US:65649-003_154842e6-a919-ba71-e063-6394a90aebd4
Trulance
Orange BookUNIISPLATC A06AX07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSalix Pharmaceuticals Inc.
CountryUS (United States)
ATC codeA06AX07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc1165649003011 BOTTLE in 1 CARTON (65649-003-01) / 1 TABLET in 1 BOTTLE
- ndc1165649003031 BOTTLE in 1 CARTON (65649-003-03) / 3 TABLET in 1 BOTTLE
- ndc1165649003071 BOTTLE in 1 CARTON (65649-003-07) / 7 TABLET in 1 BOTTLE
- ndc11656490033030 TABLET in 1 BOTTLE (65649-003-30)
Annotations
UNII (FDA Substance ID)
7IK8Z952OK
PLECANATIDE
RxCUI 1873752
Orange Book
N208745
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "7IK8Z952OK",
"rxcui": "1873752",
"inchikey": null,
"display_name": "PLECANATIDE",
"substance_type": "protein",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"fe2895bf-71a6-493a-b0ca-e06b2dfefc82": {
"match": "brand_token",
"title": "TRULANCE IMMEDIATE RELEASE (PLECANATIDE) TABLET [SALIX PHARMACEUTICALS INC.]",
"spl_version": "15",
"published_date": "2024-04-05"
}
},
"productid": "65649-003_154842e6-a919-ba71-e063-6394a90aebd4",
"productndc": "65649-003",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "208745",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "3MG",
"product_no": "001",
"approval_date": "Jan 19, 2017"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PLECANATIDE",
"proprietary_name": "Trulance",
"active_ingred_unit": "mg/1",
"application_number": "NDA208745",
"marketing_category": "NDA",
"nonproprietary_name": "Plecanatide",
"start_marketing_date": "20170221",
"active_numerator_strength": "3"
}Related drugs
Other records sharing ATC code A06AX07.
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