🇺🇸
United States · US · US:83090-009_d95da146-99a2-491f-be7e-28e5fd86928f
ARSENIC TRIOXIDE
In shortageOrange BookUNIISPLATC L01XX27
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSintetica US LLC
CountryUS (United States)
ATC codeL01XX27
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1183090009011 VIAL, SINGLE-DOSE in 1 CARTON (83090-009-01) / 10 mL in 1 VIAL, SINGLE-DOSE (83090-009-05)
- ndc11830900091010 VIAL, SINGLE-DOSE in 1 CARTON (83090-009-10) / 10 mL in 1 VIAL, SINGLE-DOSE (83090-009-05)
Annotations
UNII (FDA Substance ID)
S7V92P67HO
ARSENIC TRIOXIDE
RxCUI 18330
Orange Book
A217413
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": "83090-009_d95da146-99a2-491f-be7e-28e5fd86928f",
"productndc": "83090-009",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "217413",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "1MG/ML",
"product_no": "001",
"approval_date": "Apr 20, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "2MG/ML",
"product_no": "002",
"approval_date": "Apr 20, 2023"
}
],
"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": "ANDA217413",
"marketing_category": "ANDA",
"nonproprietary_name": "arsenic trioxide",
"start_marketing_date": "20231109",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code L01XX27.
- 🇺🇸Ars AlbEnergique, Inc.
- NLArseentrioxide CF 1 mg/ml, concentraat voor oplossing voor infusieCentrafarm B.V.
- 🇺🇸ARSENIC ALBRxhomeo Private Limited d.b.a. Rxhomeo, Inc
- 🇺🇸Arsenic trioxideZydus Pharmaceuticals USA Inc.
- 🇺🇸Arsenic trioxideZydus Pharmaceuticals USA Inc.
- 🇺🇸Arsenic trioxideZydus Pharmaceuticals USA Inc.
- 🇺🇸Arsenic trioxideZydus Lifesciences Limited
- 🇺🇸Arsenic trioxideZydus Pharmaceuticals USA Inc.
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