Isosulfan Blue

Orange BookUNIISPL

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

Identification

ManufacturerMylan Institutional LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7207806901
1 SYRINGE in 1 CARTON (72078-069-01) / 1 mL in 1 SYRINGE

Annotations

UNII (FDA Substance ID)

39N9K8S2A4

ISOSULFAN BLUE

RxCUI 27863

Orange Book

A090874

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "39N9K8S2A4",
    "rxcui": "27863",
    "inchikey": "NLUFDZBOHMOBOE-UHFFFAOYSA-M",
    "display_name": "ISOSULFAN BLUE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "0391e544-3633-48df-9f3a-ed16183125b1": {
      "match": "brand_token",
      "title": "ISOSULFAN BLUE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]",
      "spl_version": "2",
      "published_date": "2026-05-25"
    }
  },
  "productid": "72078-069_17faad04-f361-4b65-8f37-964efd5c74e0",
  "productndc": "72078-069",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "090874",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "50MG/5ML (10MG/ML)",
        "product_no": "001",
        "approval_date": "Jul 20, 2010"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "10MG/ML (10MG/ML)",
        "product_no": "002",
        "approval_date": "Jan 28, 2026"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "30MG/3ML (10MG/ML)",
        "product_no": "003",
        "approval_date": "Jan 28, 2026"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ISOSULFAN BLUE",
  "proprietary_name": "Isosulfan Blue",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA090874",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Isosulfan Blue",
  "start_marketing_date": "20260201",
  "active_numerator_strength": "10"
}

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