SUNITINIB MALATE

Orange BookUNIISPLATC L01EX

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

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeL01EX

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5965146528
28 CAPSULE in 1 BOTTLE (59651-465-28)
ndc11
5965146529
4 BLISTER PACK in 1 CARTON (59651-465-29) / 7 CAPSULE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

LVX8N1UT73

SUNITINIB MALATE

RxCUI 616275

Orange Book

A218615

ABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "LVX8N1UT73",
    "rxcui": "616275",
    "inchikey": "LBWFXVZLPYTWQI-IPOVEDGCSA-N",
    "display_name": "SUNITINIB MALATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "0772eb61-ca42-39de-e063-6294a90a6632": {
      "match": "brand_token",
      "title": "SUNITINIB MALATE CAPSULE [AVKARE]",
      "spl_version": "2",
      "published_date": "2026-01-19"
    }
  },
  "productid": "59651-465_a3d2b07e-f9d2-4f17-9a80-025d77ff8f7e",
  "productndc": "59651-465",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "218615",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 12.5MG BASE",
        "product_no": "001",
        "approval_date": "Mar 14, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "002",
        "approval_date": "Mar 14, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 37.5MG BASE",
        "product_no": "003",
        "approval_date": "Mar 14, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "004",
        "approval_date": "Mar 14, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SUNITINIB MALATE",
  "proprietary_name": "SUNITINIB MALATE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA218615",
  "marketing_category": "ANDA",
  "nonproprietary_name": "SUNITINIB MALATE",
  "start_marketing_date": "20240314",
  "active_numerator_strength": "25"
}

Related drugs

Other records sharing ATC code L01EX.

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