🇺🇸
United States · US · US:16729-243_46296320-1014-df71-e063-6294a90ac862
Topotecan
Orange BookUNIISPLATC L01CE01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAccord Healthcare Inc.
CountryUS (United States)
ATC codeL01CE01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1116729243311 VIAL, MULTI-DOSE in 1 CARTON (16729-243-31) / 4 mL in 1 VIAL, MULTI-DOSE
Annotations
UNII (FDA Substance ID)
7M7YKX2N15
TOPOTECAN
RxCUI 57308
Orange Book
A204406
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "7M7YKX2N15",
"rxcui": "57308",
"inchikey": "UCFGDBYHRUNTLO-QHCPKHFHSA-N",
"display_name": "TOPOTECAN",
"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": "16729-243_46296320-1014-df71-e063-6294a90ac862",
"productndc": "16729-243",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "204406",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 1MG BASE/ML (EQ 1MG BASE/ML)",
"product_no": "001",
"approval_date": "Jul 6, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 4MG BASE/4ML (EQ 1MG BASE/ML)",
"product_no": "002",
"approval_date": "Jul 6, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TOPOTECAN",
"proprietary_name": "Topotecan",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA204406",
"marketing_category": "ANDA",
"nonproprietary_name": "Topotecan",
"start_marketing_date": "20200708",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code L01CE01.
Access this data programmatically
Query Topotecan and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.