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United States · US · US:61269-410_656f0cdd-f6bf-444d-ade9-f1703a31da58
ETOPOPHOS
Orange BookUNIISPLATC L01CB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerH2-Pharma, LLC
CountryUS (United States)
ATC codeL01CB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1161269410201 VIAL, SINGLE-DOSE in 1 CARTON (61269-410-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
528XYJ8L1N
ETOPOSIDE PHOSPHATE
RxCUI 24614
Orange Book
N020457
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "528XYJ8L1N",
"rxcui": "24614",
"inchikey": "LIQODXNTTZAGID-OCBXBXKTSA-N",
"display_name": "ETOPOSIDE PHOSPHATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"7499fc35-fae8-44ad-bbab-9a1a589bf3ee": {
"match": "brand_token",
"title": "ETOPOPHOS (ETOPOSIDE PHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [H2-PHARMA, LLC]",
"spl_version": "22",
"published_date": "2025-11-26"
}
},
"productid": "61269-410_656f0cdd-f6bf-444d-ade9-f1703a31da58",
"productndc": "61269-410",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "020457",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 100MG BASE/VIAL",
"product_no": "001",
"approval_date": "May 17, 1996"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ETOPOSIDE PHOSPHATE",
"proprietary_name": "ETOPOPHOS",
"active_ingred_unit": "mg/1",
"application_number": "NDA020457",
"marketing_category": "NDA",
"nonproprietary_name": "etoposide phosphate",
"start_marketing_date": "20090601",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code L01CB01.
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