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United States · US · US:16729-295_35cf6068-f31a-211b-e063-6294a90a6b53

Carboplatin

In shortageOrange BookUNIISPLATC L01XA02

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

Identification

ManufacturerAccord Healthcare, Inc.
CountryUS (United States)
ATC codeL01XA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    1672929512
    1 VIAL, MULTI-DOSE in 1 CARTON (16729-295-12) / 60 mL in 1 VIAL, MULTI-DOSE
  • ndc11
    1672929531
    1 VIAL, MULTI-DOSE in 1 CARTON (16729-295-31) / 5 mL in 1 VIAL, MULTI-DOSE
  • ndc11
    1672929533
    1 VIAL, MULTI-DOSE in 1 CARTON (16729-295-33) / 15 mL in 1 VIAL, MULTI-DOSE
  • ndc11
    1672929534
    1 VIAL, MULTI-DOSE in 1 CARTON (16729-295-34) / 45 mL in 1 VIAL, MULTI-DOSE

Annotations

UNII (FDA Substance ID)
BG3F62OND5
CARBOPLATIN
RxCUI 40048
Orange Book
A206775
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": "16729-295_35cf6068-f31a-211b-e063-6294a90a6b53",
  "productndc": "16729-295",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "206775",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "50MG/5ML (10MG/ML)",
        "product_no": "001",
        "approval_date": "Feb 9, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "150MG/15ML (10MG/ML)",
        "product_no": "002",
        "approval_date": "Feb 9, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "450MG/45ML (10MG/ML)",
        "product_no": "003",
        "approval_date": "Feb 9, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "600MG/60ML (10MG/ML)",
        "product_no": "004",
        "approval_date": "Feb 9, 2017"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "1GM/100ML (10MG/ML)",
        "product_no": "005",
        "approval_date": "Apr 6, 2020"
      }
    ],
    "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": "ANDA206775",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Carboplatin",
  "start_marketing_date": "20170919",
  "active_numerator_strength": "10"
}

Related drugs

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