United States· US:70069-221_ed436868-8729-4a79-b5b5-15c1b12bde81

Isosulfan Blue

A medicinal product containing isosulfan blue, registered in United States by Somerset Therapeutics, LLC.

Orange BookUS label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedIsosulfan BlueATC—REGISTER NO.US:70069-221_ed436868…PACKS LISTED1CHECKEDJune 3, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
Isosulfan Blue
Manufacturer
Somerset Therapeutics, LLC
Country
United States (US)
ATC code
—
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
June 3, 2026

Packs & prices · 1

  • ndc11
    7006922106
    6 VIAL in 1 CARTON (70069-221-06) / 5 mL in 1 VIAL (70069-221-01)

Regulatory notes

UNII (FDA substance ID)
39N9K8S2A4
ISOSULFAN BLUE
RxCUI 27863
Orange Book
A210558
DailyMed SPL labels
1 version tracked

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/f03469ec-4d35-4ffd-b9a3-853d5f60dd98
GET /v1/drugs/f03469ec-4d35-4ffd-b9a3-853d5f60dd98?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "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": "70069-221_ed436868-8729-4a79-b5b5-15c1b12bde81",
  "productndc": "70069-221",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "210558",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "50MG/5ML (10MG/ML)",
        "product_no": "001",
        "approval_date": "Jul 12, 2019"
      }
    ],
    "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": "ANDA210558",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Isosulfan Blue",
  "start_marketing_date": "20190723",
  "active_numerator_strength": "10"
}

See everything about isosulfan blue.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.