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United States · US · US:54288-167_c0a7463c-d90f-4060-a54e-6a4888e8af0e

CARBOPLATIN

In shortageOrange BookUNIISPLATC L01XA02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerBPI Labs LLC
CountryUS (United States)
ATC codeL01XA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5428816701
    1 VIAL, MULTI-DOSE in 1 CARTON (54288-167-01) / 60 mL in 1 VIAL, MULTI-DOSE

Annotations

UNII (FDA Substance ID)
BG3F62OND5
CARBOPLATIN
RxCUI 40048
Orange Book
A207324
APAPAPAP
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": {
    "5484d2f0-0cc2-4bba-8f26-c7f6539a9606": {
      "match": "brand_token",
      "title": "CARBOPLATIN INJECTION, SOLUTION [BPI LABS LLC]",
      "spl_version": "5",
      "published_date": "2025-12-29"
    }
  },
  "productid": "54288-167_c0a7463c-d90f-4060-a54e-6a4888e8af0e",
  "productndc": "54288-167",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "207324",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "50MG/5ML (10MG/ML)",
        "product_no": "001",
        "approval_date": "Feb 15, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "150MG/15ML (10MG/ML)",
        "product_no": "002",
        "approval_date": "Feb 15, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "450MG/45ML (10MG/ML)",
        "product_no": "003",
        "approval_date": "Feb 15, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "600MG/60ML (10MG/ML)",
        "product_no": "004",
        "approval_date": "Feb 15, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CARBOPLATIN",
  "shortage_reason": "Carboplatin Injection",
  "shortage_status": "current",
  "proprietary_name": "CARBOPLATIN",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA207324",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Carboplatin",
  "start_marketing_date": "20230731",
  "active_numerator_strength": "10"
}

Related drugs

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