ELTROMBOPAG

Orange BookUNIISPLATC B02BX

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

Identification

ManufacturerZydus Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeB02BX

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7071013953
30 TABLET in 1 BOTTLE (70710-1395-3)

Annotations

UNII (FDA Substance ID)

4U07F515LG

ELTROMBOPAG OLAMINE

RxCUI 735651

Orange Book

A216281

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": "70710-1395_8f8b3109-d174-4138-b14f-f956a4578ca9",
  "productndc": "70710-1395",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "216281",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 12.5MG ACID",
        "product_no": "001",
        "approval_date": "Jan 14, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG ACID",
        "product_no": "002",
        "approval_date": "Jan 14, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG ACID",
        "product_no": "003",
        "approval_date": "Jan 14, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 75MG ACID",
        "product_no": "004",
        "approval_date": "Jan 14, 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": "ANDA216281",
  "marketing_category": "ANDA",
  "nonproprietary_name": "eltrombopag",
  "start_marketing_date": "20260114",
  "active_numerator_strength": "12.5"
}

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