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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

  • ndc11
    6564900301
    1 BOTTLE in 1 CARTON (65649-003-01) / 1 TABLET in 1 BOTTLE
  • ndc11
    6564900303
    1 BOTTLE in 1 CARTON (65649-003-03) / 3 TABLET in 1 BOTTLE
  • ndc11
    6564900307
    1 BOTTLE in 1 CARTON (65649-003-07) / 7 TABLET in 1 BOTTLE
  • ndc11
    6564900330
    30 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

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