🇺🇸
United States · US · US:68083-502_5a0916d0-90cc-4ac2-82ba-e44138161853
MITOMYCIN
Orange BookUNIISPLATC L01DC03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGland Pharma Limited
CountryUS (United States)
ATC codeL01DC03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168083502011 VIAL, SINGLE-DOSE in 1 CARTON (68083-502-01) / 80 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
50SG953SK6
MITOMYCIN
RxCUI 632
Orange Book
A216648
AP
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": "68083-502_5a0916d0-90cc-4ac2-82ba-e44138161853",
"productndc": "68083-502",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "216648",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "40MG/VIAL",
"product_no": "001",
"approval_date": "Nov 22, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MITOMYCIN",
"proprietary_name": "MITOMYCIN",
"active_ingred_unit": "mg/80mL",
"application_number": "ANDA216648",
"marketing_category": "ANDA",
"nonproprietary_name": "MITOMYCIN",
"start_marketing_date": "20221122",
"active_numerator_strength": "40"
}Related drugs
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