eltrombopag

Orange BookUNIISPLATC B02BX

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

Identification

ManufacturerDr. Reddy's Laboratories Inc.,

CountryUS (United States)

ATC codeB02BX

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4359873130
30 TABLET, FILM COATED in 1 BOTTLE (43598-731-30)

Annotations

UNII (FDA Substance ID)

4U07F515LG

ELTROMBOPAG OLAMINE

RxCUI 735651

Orange Book

A219121

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": "43598-731_5d914575-d83d-4930-26f4-c8bd10500921",
  "productndc": "43598-731",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "219121",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 12.5MG ACID",
        "product_no": "001",
        "approval_date": "Mar 16, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG ACID",
        "product_no": "002",
        "approval_date": "Mar 16, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG ACID",
        "product_no": "003",
        "approval_date": "Mar 16, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 75MG ACID",
        "product_no": "004",
        "approval_date": "Mar 16, 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": "ANDA219121",
  "marketing_category": "ANDA",
  "nonproprietary_name": "eltrombopag",
  "start_marketing_date": "20260317",
  "active_numerator_strength": "50"
}

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