Sunitinib malate

Orange BookUNIISPLATC L01EX

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

Identification

ManufacturerSun Pharmaceutical Industries Inc.

CountryUS (United States)

ATC codeL01EX

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6330409127
28 CAPSULE in 1 BOTTLE (63304-091-27)
ndc11
6330409186
4 BLISTER PACK in 1 BOX (63304-091-86) / 7 CAPSULE in 1 BLISTER PACK (63304-091-11)

Annotations

UNII (FDA Substance ID)

LVX8N1UT73

SUNITINIB MALATE

RxCUI 616275

Orange Book

A213914

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": "63304-091_2971c7ca-50dc-e36c-e063-6294a90a4b7d",
  "productndc": "63304-091",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "213914",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 12.5MG BASE",
        "product_no": "001",
        "approval_date": "Aug 16, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "002",
        "approval_date": "Aug 16, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 37.5MG BASE",
        "product_no": "003",
        "approval_date": "Aug 16, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "004",
        "approval_date": "Aug 16, 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": "ANDA213914",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sunitinib malate",
  "start_marketing_date": "20191225",
  "active_numerator_strength": "12.5"
}

Related drugs

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