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United States · US · US:84230-551_2a019a0b-29c4-d5ef-e063-6394a90ad52f

Mulpleta

Orange BookUNIISPLATC B02BX07

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerVANCOCIN ITALIA SRL
CountryUS (United States)
ATC codeB02BX07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8423055107
    1 DOSE PACK in 1 CARTON (84230-551-07) / 7 TABLET, FILM COATED in 1 DOSE PACK

Annotations

UNII (FDA Substance ID)
6LL5JFU42F
LUSUTROMBOPAG
RxCUI 2054984
Orange Book
N210923
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "6LL5JFU42F",
    "rxcui": "2054984",
    "inchikey": "NOZIJMHMKORZBA-KJCUYJGMSA-N",
    "display_name": "LUSUTROMBOPAG",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "a390aec3-6e77-45f8-95d3-d4b8c2eeee40": {
      "match": "brand_token",
      "title": "MULPLETA (LUSUTROMBOPAG) TABLET, FILM COATED [VANCOCIN ITALIA SRL]",
      "spl_version": "6",
      "published_date": "2025-12-10"
    }
  },
  "productid": "84230-551_2a019a0b-29c4-d5ef-e063-6394a90ad52f",
  "productndc": "84230-551",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "210923",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "3MG",
        "product_no": "001",
        "approval_date": "Jul 31, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LUSUTROMBOPAG",
  "proprietary_name": "Mulpleta",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA210923",
  "marketing_category": "NDA",
  "nonproprietary_name": "Lusutrombopag",
  "start_marketing_date": "20251209",
  "active_numerator_strength": "3"
}

Related drugs

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