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United States · US · US:68083-484_64496224-9cec-48bb-a750-db192dd7780c
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
- ndc1168083484011 VIAL in 1 CARTON (68083-484-01) / 40 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
50SG953SK6
MITOMYCIN
RxCUI 632
Orange Book
A215687
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": "68083-484_64496224-9cec-48bb-a750-db192dd7780c",
"productndc": "68083-484",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "215687",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "5MG/VIAL",
"product_no": "001",
"approval_date": "Oct 20, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "20MG/VIAL",
"product_no": "002",
"approval_date": "Oct 20, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MITOMYCIN",
"proprietary_name": "MITOMYCIN",
"active_ingred_unit": "mg/40mL",
"application_number": "ANDA215687",
"marketing_category": "ANDA",
"nonproprietary_name": "MITOMYCIN",
"start_marketing_date": "20211020",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code L01DC03.
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