🇺🇸
United States · US · US:42658-008_1b25a447-d782-5889-e063-6294a90aebe5
Dactinomycin
Orange BookUNIISPLATC L01DA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHisun Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeL01DA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1142658008011 VIAL in 1 CARTON (42658-008-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
Annotations
UNII (FDA Substance ID)
1CC1JFE158
DACTINOMYCIN
RxCUI 3100
Orange Book
A207232
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "1CC1JFE158",
"rxcui": "3100",
"inchikey": "RJURFGZVJUQBHK-IIXSONLDSA-N",
"display_name": "DACTINOMYCIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"5da55538-2602-4704-a9da-603c9f7ff7dc": {
"match": "brand_token",
"title": "DACTINOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [EUGIA US LLC]",
"spl_version": "2",
"published_date": "2024-06-19"
}
},
"productid": "42658-008_1b25a447-d782-5889-e063-6294a90aebe5",
"productndc": "42658-008",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "207232",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "0.5MG/VIAL",
"product_no": "001",
"approval_date": "Jul 16, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DACTINOMYCIN",
"proprietary_name": "Dactinomycin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA207232",
"marketing_category": "ANDA",
"nonproprietary_name": "dactinomycin",
"start_marketing_date": "20240508",
"active_numerator_strength": ".5"
}Related drugs
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