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United States · US · US:39822-2100_19853d49-64c6-f1cd-e063-6294a90a9c95
dactinomycin
Orange BookUNIISPLATC L01DA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerXGen Pharmaceuticals DJB, Inc.
CountryUS (United States)
ATC codeL01DA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1139822210021 VIAL, SINGLE-DOSE in 1 CARTON (39822-2100-2) / 1 mL in 1 VIAL, SINGLE-DOSE (39822-2100-1)
Annotations
UNII (FDA Substance ID)
1CC1JFE158
DACTINOMYCIN
RxCUI 3100
Orange Book
A203999
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": "39822-2100_19853d49-64c6-f1cd-e063-6294a90a9c95",
"productndc": "39822-2100",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "203999",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "0.5MG/VIAL",
"product_no": "001",
"approval_date": "May 20, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DACTINOMYCIN",
"proprietary_name": "dactinomycin",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA203999",
"marketing_category": "ANDA",
"nonproprietary_name": "dactinomycin",
"start_marketing_date": "20190731",
"active_numerator_strength": ".5"
}Related drugs
Other records sharing ATC code L01DA01.
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- 🇫🇷COSMEGEN 0,5 mg, poudre pour solution injectableRECORDATI RARE DISEASES
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- 🇺🇸DactinomycinMeitheal Pharmaceuticals Inc.
- 🇺🇸DactinomycinHisun Pharmaceuticals USA, Inc.
- 🇺🇸DACTINOMYCINEugia US LLC
- 🇺🇸DACTINOMYCINEugia US LLC
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