🇺🇸
United States · US · US:45963-615_0edbf531-9ae9-4f9d-a606-f8f56768ce9d
Topotecan hydrochloride
Orange BookUNIISPLATC L01CE01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerActavis Pharma, Inc.
CountryUS (United States)
ATC codeL01CE01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1145963615561 VIAL in 1 CARTON (45963-615-56) / 4 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
956S425ZCY
TOPOTECAN HYDROCHLORIDE
RxCUI 266573
Orange Book
A090620
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": "45963-615_0edbf531-9ae9-4f9d-a606-f8f56768ce9d",
"productndc": "45963-615",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "090620",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 4MG BASE/VIAL",
"product_no": "001",
"approval_date": "Dec 2, 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": "ANDA090620",
"marketing_category": "ANDA",
"nonproprietary_name": "Topotecan hydrochloride",
"start_marketing_date": "20150105",
"active_numerator_strength": "4"
}Related drugs
Other records sharing ATC code L01CE01.
Access this data programmatically
Query Topotecan hydrochloride 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.