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United States · US · US:66758-102_b23b46f5-c276-47f5-8bbd-940680b3f579
HYCAMTIN
Orange BookUNIISPLATC L01CE01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSandoz Inc
CountryUS (United States)
ATC codeL01CE01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11667581021110 CAPSULE in 1 BOTTLE (66758-102-11)
Annotations
UNII (FDA Substance ID)
956S425ZCY
TOPOTECAN HYDROCHLORIDE
RxCUI 266573
Orange Book
N020981
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "956S425ZCY",
"rxcui": "266573",
"inchikey": "DGHHQBMTXTWTJV-BQAIUKQQSA-N",
"display_name": "TOPOTECAN HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"b23b46f5-c276-47f5-8bbd-940680b3f579": {
"match": "brand_token",
"title": "HYCAMTIN (TOPOTECAN) CAPSULE [SANDOZ INC]",
"spl_version": "1",
"published_date": "2024-10-31"
}
},
"productid": "66758-102_b23b46f5-c276-47f5-8bbd-940680b3f579",
"productndc": "66758-102",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "020981",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 0.25MG BASE",
"product_no": "001",
"approval_date": "Oct 11, 2007"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 1MG BASE",
"product_no": "002",
"approval_date": "Oct 11, 2007"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TOPOTECAN HYDROCHLORIDE",
"proprietary_name": "HYCAMTIN",
"active_ingred_unit": "mg/1",
"application_number": "NDA020981",
"marketing_category": "NDA",
"nonproprietary_name": "topotecan",
"start_marketing_date": "20170224",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code L01CE01.
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