SUNITINIB MALATE

Orange BookUNIISPLATC L01EX

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

Identification

ManufacturerDr.Reddys Laboratories Inc

CountryUS (United States)

ATC codeL01EX

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
4359804528
4 BLISTER PACK in 1 CARTON (43598-045-28) / 7 CAPSULE in 1 BLISTER PACK (43598-045-70)
ndc11
4359804563
28 CAPSULE in 1 BOTTLE (43598-045-63)

Annotations

UNII (FDA Substance ID)

LVX8N1UT73

SUNITINIB MALATE

RxCUI 616275

Orange Book

A215843

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": "43598-045_664e6a61-82ff-5756-1fc1-9266090d901e",
  "productndc": "43598-045",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "215843",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 12.5MG BASE",
        "product_no": "001",
        "approval_date": "Apr 11, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "002",
        "approval_date": "Apr 11, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 37.5MG BASE",
        "product_no": "003",
        "approval_date": "Apr 11, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "004",
        "approval_date": "Apr 11, 2022"
      }
    ],
    "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": "ANDA215843",
  "marketing_category": "ANDA",
  "nonproprietary_name": "SUNITINIB MALATE",
  "start_marketing_date": "20221130",
  "active_numerator_strength": "12.5"
}

Related drugs

Other records sharing ATC code L01EX.

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