🇺🇸
United States · US · US:68083-388_31a8c608-3ad6-44fe-aec8-621a8b991677
Dexrazoxane
Orange BookUNIISPLATC V03AF02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGland Pharma Limited
CountryUS (United States)
ATC codeV03AF02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168083388011 VIAL in 1 CARTON (68083-388-01) / 25 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
5346058Q7S
DEXRAZOXANE HYDROCHLORIDE
RxCUI 1294534
Orange Book
A207321
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": "68083-388_31a8c608-3ad6-44fe-aec8-621a8b991677",
"productndc": "68083-388",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "207321",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 500MG BASE/VIAL",
"product_no": "001",
"approval_date": "Nov 28, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 250MG BASE/VIAL",
"product_no": "002",
"approval_date": "Dec 16, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DEXRAZOXANE HYDROCHLORIDE",
"proprietary_name": "Dexrazoxane",
"active_ingred_unit": "mg/25mL",
"application_number": "ANDA207321",
"marketing_category": "ANDA",
"nonproprietary_name": "Dexrazoxane for Injection",
"start_marketing_date": "20191216",
"active_numerator_strength": "250"
}Related drugs
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