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United States · US · US:73077-010_889accaa-7f62-4da4-84ea-80ecfb144209

PEDMARK

In shortageOrange BookUNIISPLATC V03AB

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

Identification

ManufacturerFennec Pharmaceuticals Inc.
CountryUS (United States)
ATC codeV03AB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7307701001
    1 VIAL, SINGLE-DOSE in 1 BOX, UNIT-DOSE (73077-010-01) / 100 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
HX1032V43M
SODIUM THIOSULFATE
RxCUI 36726
Orange Book
N212937
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Sodium Chloride 0.9% Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "HX1032V43M",
    "rxcui": "36726",
    "inchikey": "PODWXQQNRWNDGD-UHFFFAOYSA-L",
    "display_name": "SODIUM THIOSULFATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "f98c7076-2a7b-4fd7-ab90-eed5e9137bae": {
      "match": "brand_token",
      "title": "PEDMARK (SODIUM THIOSULFATE) INJECTION, SOLUTION [FENNEC PHARMACEUTICALS INC.]",
      "spl_version": "7",
      "published_date": "2025-11-17"
    }
  },
  "productid": "73077-010_889accaa-7f62-4da4-84ea-80ecfb144209",
  "productndc": "73077-010",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "212937",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "12.5GM/100ML (125MG/ML)",
        "product_no": "001",
        "approval_date": "Sep 20, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SODIUM THIOSULFATE",
  "shortage_reason": "Sodium Chloride 0.9% Injection",
  "shortage_status": "current",
  "proprietary_name": "PEDMARK",
  "active_ingred_unit": "g/100mL",
  "application_number": "NDA212937",
  "marketing_category": "NDA",
  "nonproprietary_name": "SODIUM THIOSULFATE",
  "start_marketing_date": "20221003",
  "active_numerator_strength": "12.5"
}

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