🇺🇸
United States · US · US:72205-248_bdcb7617-046b-4db9-94ba-b10102565868
Dexrazoxane
Orange BookUNIISPLATC V03AF02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNovadoz Pharmaceuticals LLC
CountryUS (United States)
ATC codeV03AF02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1172205248011 VIAL, SINGLE-DOSE in 1 CARTON (72205-248-01) / 50 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
5346058Q7S
DEXRAZOXANE HYDROCHLORIDE
RxCUI 1294534
Orange Book
A216748
APAP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "5346058Q7S",
"rxcui": "1294534",
"inchikey": "BIFMNMPSIYHKDN-FJXQXJEOSA-N",
"display_name": "DEXRAZOXANE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"9cbd2987-10bb-eceb-153d-ee7be1ed0c84": {
"match": "brand_token",
"title": "DEXRAZOXANE (DEXRAZOXANE FOR INJECTION) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ALMAJECT, INC.]",
"spl_version": "4",
"published_date": "2025-12-16"
}
},
"productid": "72205-248_bdcb7617-046b-4db9-94ba-b10102565868",
"productndc": "72205-248",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "216748",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 250MG BASE/VIAL",
"product_no": "001",
"approval_date": "Mar 26, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 500MG BASE/VIAL",
"product_no": "002",
"approval_date": "Mar 26, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DEXRAZOXANE HYDROCHLORIDE",
"proprietary_name": "Dexrazoxane",
"active_ingred_unit": "mg/50mL",
"application_number": "ANDA216748",
"marketing_category": "ANDA",
"nonproprietary_name": "Dexrazoxane",
"start_marketing_date": "20250326",
"active_numerator_strength": "500"
}Related drugs
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- 🇫🇷CARDIOXANE 500 mg, poudre pour solution pour perfusionCNX THERAPEUTICS IRELAND LIMITED (IRLANDE)
- GBCardioxane 500mg powder for solution for infusion vialsCNX Therapeutics Ltd
- PLCyrdanaxPharmaselect International Beteiligungs GmbH
- 🇺🇸DexrazoxaneGland Pharma Limited
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