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United States · US · US:0409-0302_293334d4-88f2-4ec2-9eed-20975ff65c0a
Topotecan
Orange BookUNIISPLATC L01CE01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHospira, Inc.
CountryUS (United States)
ATC codeL01CE01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1104090302011 VIAL, SINGLE-DOSE in 1 CARTON (0409-0302-01) / 4 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
956S425ZCY
TOPOTECAN HYDROCHLORIDE
RxCUI 266573
Orange Book
N200582
AP
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": "INTRAVENOUS",
"spl_meta": {
"b6019088-cd94-43b4-b5ce-ba20b6b8021e": {
"match": "brand_token",
"title": "TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]",
"spl_version": "15",
"published_date": "2026-02-09"
}
},
"productid": "0409-0302_293334d4-88f2-4ec2-9eed-20975ff65c0a",
"productndc": "0409-0302",
"dosage_form": "INJECTION, SOLUTION, CONCENTRATE",
"orange_book": {
"appl_no": "200582",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "EQ 4MG BASE/4ML (EQ 1MG BASE/ML)",
"product_no": "001",
"approval_date": "Feb 2, 2011"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TOPOTECAN HYDROCHLORIDE",
"proprietary_name": "Topotecan",
"active_ingred_unit": "mg/mL",
"application_number": "NDA200582",
"marketing_category": "NDA",
"nonproprietary_name": "TOPOTECAN",
"start_marketing_date": "20110221",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code L01CE01.
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