Sunitinib Malate

Orange BookUNIISPLATC L01EX

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

Identification

ManufacturerNovugen Pharma (USA) LLC.

CountryUS (United States)

ATC codeL01EX

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8229301710
28 CAPSULE in 1 BOTTLE (82293-017-10)

Annotations

UNII (FDA Substance ID)

LVX8N1UT73

SUNITINIB MALATE

RxCUI 616275

Orange Book

A218012

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": "82293-017_21d0ff80-d937-abb3-e063-6394a90af4b7",
  "productndc": "82293-017",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "218012",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 12.5MG BASE",
        "product_no": "001",
        "approval_date": "Aug 21, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "002",
        "approval_date": "Aug 21, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 37.5MG BASE",
        "product_no": "003",
        "approval_date": "Aug 21, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "004",
        "approval_date": "Aug 21, 2023"
      }
    ],
    "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": "ANDA218012",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sunitinib Malate",
  "start_marketing_date": "20240501",
  "active_numerator_strength": "50"
}

Related drugs

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