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United States · US · US:63323-762_7f91362f-6b55-4518-b034-b54aa5881204
Topotecan Hydrochloride
Orange BookUNIISPLATC L01CE01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeL01CE01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1163323762101 VIAL in 1 BOX (63323-762-10) / 4 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
956S425ZCY
TOPOTECAN HYDROCHLORIDE
RxCUI 266573
Orange Book
A091089
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": "63323-762_7f91362f-6b55-4518-b034-b54aa5881204",
"productndc": "63323-762",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "091089",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 4MG BASE/VIAL",
"product_no": "001",
"approval_date": "Nov 29, 2010"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TOPOTECAN HYDROCHLORIDE",
"proprietary_name": "Topotecan Hydrochloride",
"active_ingred_unit": "mg/4mL",
"application_number": "ANDA091089",
"marketing_category": "ANDA",
"nonproprietary_name": "TOPOTECAN HYDROCHLORIDE",
"start_marketing_date": "20101130",
"active_numerator_strength": "4"
}Related drugs
Other records sharing ATC code L01CE01.
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