🇺🇸
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
- ndc1173077010011 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"
}Related drugs
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