🇺🇸
United States · US · US:55150-928_f7cacd7d-479f-4a00-8db6-f11ad039b314
DACTINOMYCIN
Orange BookUNIISPLATC L01DA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEugia US LLC
CountryUS (United States)
ATC codeL01DA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1155150928021 VIAL, SINGLE-DOSE in 1 CARTON (55150-928-02) / 1 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
1CC1JFE158
DACTINOMYCIN
RxCUI 3100
Orange Book
A203385
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": "55150-928_f7cacd7d-479f-4a00-8db6-f11ad039b314",
"productndc": "55150-928",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "203385",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "0.5MG/VIAL",
"product_no": "001",
"approval_date": "Nov 9, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DACTINOMYCIN",
"proprietary_name": "DACTINOMYCIN",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA203385",
"marketing_category": "ANDA",
"nonproprietary_name": "DACTINOMYCIN",
"start_marketing_date": "20210315",
"active_numerator_strength": ".5"
}Related drugs
Other records sharing ATC code L01DA01.
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- 🇺🇸dactinomycinXGen Pharmaceuticals DJB, Inc.
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- 🇺🇸DACTINOMYCINEugia US LLC
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