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United States · US · US:0143-9247_032583c8-f4e7-4105-b92e-b5c3f96ca80e
Dexrazoxane
Orange BookUNIISPLATC V03AF02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeV03AF02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1101439247011 VIAL in 1 BOX (0143-9247-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
Annotations
UNII (FDA Substance ID)
5346058Q7S
DEXRAZOXANE HYDROCHLORIDE
RxCUI 1294534
Orange Book
A076068
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": "0143-9247_032583c8-f4e7-4105-b92e-b5c3f96ca80e",
"productndc": "0143-9247",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "076068",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 250MG BASE/VIAL",
"product_no": "001",
"approval_date": "Sep 28, 2004"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 500MG BASE/VIAL",
"product_no": "002",
"approval_date": "Sep 28, 2004"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DEXRAZOXANE HYDROCHLORIDE",
"proprietary_name": "Dexrazoxane",
"active_ingred_unit": "mg/1",
"application_number": "ANDA076068",
"marketing_category": "ANDA",
"nonproprietary_name": "Dexrazoxane",
"start_marketing_date": "20050331",
"active_numerator_strength": "250"
}Related drugs
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- 🇺🇸DexrazoxaneGland Pharma Limited
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