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United States · US · US:85320-551_450774dd-f9dc-b934-e063-6294a90a9a6e

Mulpleta

Orange BookUNIISPLATC B02BX07

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

Identification

ManufacturerEddingpharm (U. S. ) Inc.
CountryUS (United States)
ATC codeB02BX07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8532055107
    1 DOSE PACK in 1 CARTON (85320-551-07) / 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": "85320-551_450774dd-f9dc-b934-e063-6294a90a9a6e",
  "productndc": "85320-551",
  "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": "20251124",
  "active_numerator_strength": "3"
}

Related drugs

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