ALVAIZ

Orange BookUNIISPLATC B02BX

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

Identification

ManufacturerTeva Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeB02BX

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0480327456
30 TABLET, FILM COATED in 1 BOTTLE (0480-3274-56)

Annotations

UNII (FDA Substance ID)

F9G8XE24IB

ELTROMBOPAG CHOLINE

Orange Book

N216774

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "F9G8XE24IB",
    "rxcui": null,
    "inchikey": "XSHFVAAXJHNDKZ-OUFJFOJPSA-M",
    "display_name": "ELTROMBOPAG CHOLINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "ed51e463-7a03-4858-bbd2-882ce4753d5a": {
      "match": "brand_token",
      "title": "ALVAIZ (ELTROMBOPAG) TABLET, FILM COATED [TEVA PHARMACEUTICALS, INC.]",
      "spl_version": "7",
      "published_date": "2026-02-04"
    }
  },
  "productid": "0480-3274_a573cf28-59db-4cb3-84db-af7b77200b66",
  "productndc": "0480-3274",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "216774",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 9MG BASE",
        "product_no": "001",
        "approval_date": "Nov 29, 2023"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 18MG BASE",
        "product_no": "002",
        "approval_date": "Nov 29, 2023"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 36MG BASE",
        "product_no": "003",
        "approval_date": "Nov 29, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 54MG BASE",
        "product_no": "004",
        "approval_date": "Nov 29, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ELTROMBOPAG CHOLINE",
  "proprietary_name": "ALVAIZ",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA216774",
  "marketing_category": "NDA",
  "nonproprietary_name": "Eltrombopag",
  "start_marketing_date": "20240213",
  "active_numerator_strength": "18"
}

Related drugs

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