🇺🇸
United States · US · US:0078-0674_e6e4f66b-e398-44d3-a832-e5a809f3e861
HYCAMTIN
Orange BookUNIISPLATC L01CE01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNovartis Pharmaceuticals Corporation
CountryUS (United States)
ATC codeL01CE01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1100780674611 VIAL, SINGLE-DOSE in 1 CARTON (0078-0674-61) / 4 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
956S425ZCY
TOPOTECAN HYDROCHLORIDE
RxCUI 266573
Orange Book
N020671
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": {
"b23b46f5-c276-47f5-8bbd-940680b3f579": {
"match": "brand_token",
"title": "HYCAMTIN (TOPOTECAN) CAPSULE [SANDOZ INC]",
"spl_version": "1",
"published_date": "2024-10-31"
}
},
"productid": "0078-0674_e6e4f66b-e398-44d3-a832-e5a809f3e861",
"productndc": "0078-0674",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "020671",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "EQ 4MG BASE/VIAL",
"product_no": "001",
"approval_date": "May 28, 1996"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TOPOTECAN HYDROCHLORIDE",
"proprietary_name": "HYCAMTIN",
"active_ingred_unit": "mg/4mL",
"application_number": "NDA020671",
"marketing_category": "NDA",
"nonproprietary_name": "topotecan hydrochloride",
"start_marketing_date": "20161221",
"active_numerator_strength": "4"
}Related drugs
Other records sharing ATC code L01CE01.
Access this data programmatically
Query HYCAMTIN 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.