KYXATA

In shortageOrange BookUNIISPLATC L01XA02

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

Identification

ManufacturerAvyxa Pharma, LLC

CountryUS (United States)

ATC codeL01XA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8383114108
1 VIAL, MULTI-DOSE in 1 CARTON (83831-141-08) / 8 mL in 1 VIAL, MULTI-DOSE

Annotations

UNII (FDA Substance ID)

BG3F62OND5

CARBOPLATIN

RxCUI 40048

Orange Book

N219921

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Carboplatin Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "BG3F62OND5",
    "rxcui": "40048",
    "inchikey": "OLESAACUTLOWQZ-UHFFFAOYSA-L",
    "display_name": "CARBOPLATIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "f91c48da-68d1-4aa7-89b8-d84a3e8b629b": {
      "match": "brand_token",
      "title": "KYXATA (CARBOPLATIN) INJECTION [AVYXA PHARMA, LLC]",
      "spl_version": "6",
      "published_date": "2025-09-11"
    }
  },
  "productid": "83831-141_5c711945-70be-42f4-b153-e1459dd9929c",
  "productndc": "83831-141",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "219921",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "20MG/2ML (10MG/ML)",
        "product_no": "001",
        "approval_date": "Aug 8, 2025"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "80MG/8ML (10MG/ML)",
        "product_no": "002",
        "approval_date": "Aug 8, 2025"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "500MG/50ML (10MG/ML)",
        "product_no": "003",
        "approval_date": "Aug 8, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CARBOPLATIN",
  "shortage_reason": "Carboplatin Injection",
  "shortage_status": "current",
  "proprietary_name": "KYXATA",
  "active_ingred_unit": "mg/8mL",
  "application_number": "NDA219921",
  "marketing_category": "NDA",
  "nonproprietary_name": "CARBOplatin",
  "start_marketing_date": "20250910",
  "active_numerator_strength": "80"
}

Related drugs

Other records sharing ATC code L01XA02.

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