Eltrombopag

Orange BookUNIISPLATC B02BX

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeB02BX

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0054096313
30 TABLET in 1 BOTTLE (0054-0963-13)

Annotations

UNII (FDA Substance ID)

4U07F515LG

ELTROMBOPAG OLAMINE

RxCUI 735651

Orange Book

A220033

ABABABAB

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": {
    "4af8f855-f710-e96f-e063-6294a90abb46": {
      "match": "brand_token",
      "title": "ELTROMBOPAG OLAMINE (ELTROMBOPAG) TABLET, FILM COATED [AVKARE]",
      "spl_version": "2",
      "published_date": "2026-05-22"
    }
  },
  "productid": "0054-0963_64b1a316-d824-44b2-a0c6-785001e11c82",
  "productndc": "0054-0963",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "220033",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 12.5MG ACID",
        "product_no": "001",
        "approval_date": "Apr 8, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG ACID",
        "product_no": "002",
        "approval_date": "Apr 8, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG ACID",
        "product_no": "003",
        "approval_date": "Apr 8, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 75MG ACID",
        "product_no": "004",
        "approval_date": "Apr 8, 2026"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ELTROMBOPAG OLAMINE",
  "proprietary_name": "Eltrombopag",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA220033",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Eltrombopag Olamine",
  "start_marketing_date": "20260424",
  "active_numerator_strength": "25"
}

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