🇺🇸
United States · US · US:68083-462_dbad2610-ef0d-4733-a28a-3428ff59f56a
Arsenic Trioxide
In shortageOrange BookUNIISPLATC L01XX27
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGland Pharma Limited
CountryUS (United States)
ATC codeL01XX27
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11680834621010 VIAL, SINGLE-DOSE in 1 CARTON (68083-462-10) / 6 mL in 1 VIAL, SINGLE-DOSE (68083-462-01)
Annotations
UNII (FDA Substance ID)
S7V92P67HO
ARSENIC TRIOXIDE
RxCUI 18330
Orange Book
A215059
APAP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Arsenic Trioxide Injection
Raw payload (JSON)
{
"unii": {
"unii": "S7V92P67HO",
"rxcui": "18330",
"inchikey": "IKWTVSLWAPBBKU-UHFFFAOYSA-N",
"display_name": "ARSENIC TRIOXIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"c99b01b4-67ff-4793-8375-fe3a21c6c9be": {
"match": "brand_token",
"title": "ARSENIC TRIOXIDE INJECTION [INGENUS PHARMACEUTICALS, LLC]",
"spl_version": "11",
"published_date": "2025-12-11"
}
},
"productid": "68083-462_dbad2610-ef0d-4733-a28a-3428ff59f56a",
"productndc": "68083-462",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "215059",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "2MG/ML",
"product_no": "001",
"approval_date": "Oct 7, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "1MG/ML",
"product_no": "002",
"approval_date": "Apr 22, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ARSENIC TRIOXIDE",
"shortage_reason": "Arsenic Trioxide Injection",
"shortage_status": "current",
"proprietary_name": "Arsenic Trioxide",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA215059",
"marketing_category": "ANDA",
"nonproprietary_name": "Arsenic Trioxide",
"start_marketing_date": "20211007",
"active_numerator_strength": "2"
}Related drugs
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