NITHIODOTE

Orange BookSPL

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

Identification

ManufacturerHope Pharmaceuticals

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6026781200
1 KIT in 1 CARTON (60267-812-00) * 10 mL in 1 VIAL, SINGLE-USE (60267-311-10) * 50 mL in 1 VIAL, SINGLE-DOSE (60267-705-50)

Annotations

Orange Book

N201444

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "ff4941b3-9901-4aab-adcf-c5327bede34e": {
      "match": "brand_token",
      "title": "NITHIODOTE (SODIUM NITRITE AND SODIUM THIOSULFATE) KIT [HOPE PHARMACEUTICALS]",
      "spl_version": "10",
      "published_date": "2025-11-17"
    }
  },
  "productid": "60267-812_74809468-0182-485a-bf62-e09489756a36",
  "productndc": "60267-812",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "201444",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)",
        "product_no": "001",
        "approval_date": "Jan 14, 2011"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "NITHIODOTE",
  "active_ingred_unit": null,
  "application_number": "NDA201444",
  "marketing_category": "NDA",
  "nonproprietary_name": "Sodium Nitrite and Sodium Thiosulfate",
  "start_marketing_date": "20110114",
  "active_numerator_strength": null
}

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