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United States · US · US:71288-129_d9bb02eb-3f9e-4932-bdcd-53b5bd6392b6
Dactinomycin
Orange BookUNIISPLATC L01DA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMeitheal Pharmaceuticals Inc.
CountryUS (United States)
ATC codeL01DA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1171288129021 VIAL, SINGLE-DOSE in 1 CARTON (71288-129-02) / 1 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
1CC1JFE158
DACTINOMYCIN
RxCUI 3100
Orange Book
A213463
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": "71288-129_d9bb02eb-3f9e-4932-bdcd-53b5bd6392b6",
"productndc": "71288-129",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "213463",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "0.5MG/VIAL",
"product_no": "001",
"approval_date": "Nov 13, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DACTINOMYCIN",
"proprietary_name": "Dactinomycin",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA213463",
"marketing_category": "ANDA",
"nonproprietary_name": "Dactinomycin",
"start_marketing_date": "20201113",
"active_numerator_strength": ".5"
}Related drugs
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