SUTENT

Orange BookUNIISPLATC L01EX

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

Identification

ManufacturerPfizer Laboratories Div Pfizer Inc

CountryUS (United States)

ATC codeL01EX

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0069083038
28 CAPSULE in 1 BOTTLE (0069-0830-38)

Annotations

UNII (FDA Substance ID)

LVX8N1UT73

SUNITINIB MALATE

RxCUI 616275

Orange Book

N021938

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": {
    "43a4d7f8-48ae-4a63-9108-2fa8e3ea9d9c": {
      "match": "brand_token",
      "title": "SUTENT (SUNITINIB MALATE) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]",
      "spl_version": "50",
      "published_date": "2026-02-23"
    }
  },
  "productid": "0069-0830_530eef58-b5ab-49f1-8d73-a2dae0356f24",
  "productndc": "0069-0830",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "021938",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 12.5MG BASE",
        "product_no": "001",
        "approval_date": "Jan 26, 2006"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "002",
        "approval_date": "Jan 26, 2006"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "003",
        "approval_date": "Jan 26, 2006"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 37.5MG BASE",
        "product_no": "004",
        "approval_date": "Mar 31, 2009"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SUNITINIB MALATE",
  "proprietary_name": "SUTENT",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021938",
  "marketing_category": "NDA",
  "nonproprietary_name": "Sunitinib malate",
  "start_marketing_date": "20140712",
  "active_numerator_strength": "37.5"
}

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