PROMACTA

Orange BookUNIISPLATC B02BX

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerNovartis Pharmaceuticals Corporation

CountryUS (United States)

ATC codeB02BX

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0078097261
1 CARTON in 1 KIT (0078-0972-61) / 30 PACKET in 1 CARTON (0078-0972-23) / 1 POWDER, FOR SUSPENSION in 1 PACKET (0078-0972-19)

Annotations

UNII (FDA Substance ID)

4U07F515LG

ELTROMBOPAG OLAMINE

RxCUI 735651

Orange Book

N207027

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "4U07F515LG",
    "rxcui": "735651",
    "inchikey": "PLILLUUXAVKBPY-SBIAVEDLSA-N",
    "display_name": "ELTROMBOPAG OLAMINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "7714a0ed-34bb-46e6-a0a5-b363908b22c2": {
      "match": "brand_token",
      "title": "PROMACTA (ELTROMBOPAG OLAMINE) TABLET, FILM COATED PROMACTA (ELTROMBOPAG OLAMINE) POWDER, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]",
      "spl_version": "31",
      "published_date": "2025-12-19"
    }
  },
  "productid": "0078-0972_b8a1cc48-9aaf-486a-9305-090acccb5c02",
  "productndc": "0078-0972",
  "dosage_form": "POWDER, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "207027",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 25MG ACID/PACKET",
        "product_no": "001",
        "approval_date": "Aug 24, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 12.5MG ACID/PACKET",
        "product_no": "002",
        "approval_date": "Sep 27, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ELTROMBOPAG OLAMINE",
  "proprietary_name": "PROMACTA",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA207027",
  "marketing_category": "NDA",
  "nonproprietary_name": "eltrombopag olamine",
  "start_marketing_date": "20180927",
  "active_numerator_strength": "12.5"
}

Related drugs

Other records sharing ATC code B02BX.

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