Idarubicin Hydrochloride

Orange BookUNIISPLATC L01DB06

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

Identification

ManufacturerMeitheal Pharmaceuticals Inc.

CountryUS (United States)

ATC codeL01DB06

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7128818510
1 VIAL, SINGLE-DOSE in 1 CARTON (71288-185-10) / 10 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

5VV3MDU5IE

IDARUBICIN HYDROCHLORIDE

RxCUI 82124

Orange Book

A065036

APAPAP

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "5VV3MDU5IE",
    "rxcui": "82124",
    "inchikey": "JVHPTYWUBOQMBP-RVFAQHLVSA-N",
    "display_name": "IDARUBICIN HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "d31254be-6bd2-4ac1-acab-bc00e2209d28": {
      "match": "brand_token",
      "title": "IDARUBICIN HYDROCHLORIDE INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.]",
      "spl_version": "1",
      "published_date": "2025-06-02"
    }
  },
  "productid": "71288-185_677002b4-7b30-4d32-ae99-5ee630c5b5fb",
  "productndc": "71288-185",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "065036",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "5MG/5ML (1MG/ML)",
        "product_no": "001",
        "approval_date": "May 1, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "10MG/10ML (1MG/ML)",
        "product_no": "002",
        "approval_date": "May 1, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "20MG/20ML (1MG/ML)",
        "product_no": "003",
        "approval_date": "May 1, 2002"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IDARUBICIN HYDROCHLORIDE",
  "proprietary_name": "Idarubicin Hydrochloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA065036",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Idarubicin Hydrochloride",
  "start_marketing_date": "20250601",
  "active_numerator_strength": "1"
}

Related drugs

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