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United States · US · US:72819-153_fd60f15a-95d0-b4ae-e053-6394a90a355c
Mitomycin
Orange BookUNIISPLATC L01DC03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerArchis Pharma LLC
CountryUS (United States)
ATC codeL01DC03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1172819153021 VIAL in 1 CARTON (72819-153-02) / 40 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
50SG953SK6
MITOMYCIN
RxCUI 632
Orange Book
A202670
APAP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "50SG953SK6",
"rxcui": "632",
"inchikey": "NWIBSHFKIJFRCO-WUDYKRTCSA-N",
"display_name": "MITOMYCIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"5917f7a7-cd20-407b-8dda-9fd58c5f47a6": {
"match": "brand_token",
"title": "MITOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]",
"spl_version": "5",
"published_date": "2026-06-01"
}
},
"productid": "72819-153_fd60f15a-95d0-b4ae-e053-6394a90a355c",
"productndc": "72819-153",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "202670",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "5MG/VIAL",
"product_no": "001",
"approval_date": "Oct 13, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "20MG/VIAL",
"product_no": "002",
"approval_date": "Oct 13, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MITOMYCIN",
"proprietary_name": "Mitomycin",
"active_ingred_unit": "mg/40mL",
"application_number": "ANDA202670",
"marketing_category": "ANDA",
"nonproprietary_name": "Mitomycin",
"start_marketing_date": "20220425",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code L01DC03.
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