Sunitinib Malate

Orange BookUNIISPLATC L01EX

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

Identification

ManufacturerAvKARE

CountryUS (United States)

ATC codeL01EX

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4229190428
28 CAPSULE in 1 BOTTLE (42291-904-28)

Annotations

UNII (FDA Substance ID)

LVX8N1UT73

SUNITINIB MALATE

RxCUI 616275

Orange Book

A213803

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": "42291-904_4884360d-03d2-1af6-e063-6294a90aedf6",
  "productndc": "42291-904",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "213803",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 12.5MG BASE",
        "product_no": "001",
        "approval_date": "Nov 30, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "002",
        "approval_date": "Nov 30, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 37.5MG BASE",
        "product_no": "003",
        "approval_date": "Nov 30, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "004",
        "approval_date": "Nov 30, 2021"
      }
    ],
    "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": "ANDA213803",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sunitinib Malate",
  "start_marketing_date": "20231011",
  "active_numerator_strength": "50"
}

Related drugs

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