🇺🇸
United States · US · US:71288-138_a78f4900-61e4-4e22-bfcb-6b5210c94c57
MITOMYCIN
Orange BookUNIISPLATC L01DC03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMeitheal Pharmaceuticals Inc.
CountryUS (United States)
ATC codeL01DC03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1171288138501 VIAL, SINGLE-DOSE in 1 CARTON (71288-138-50) / 40 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
50SG953SK6
MITOMYCIN
RxCUI 632
Orange Book
A214505
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": "71288-138_a78f4900-61e4-4e22-bfcb-6b5210c94c57",
"productndc": "71288-138",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "214505",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "5MG/VIAL",
"product_no": "001",
"approval_date": "Sep 8, 2022"
},
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "20MG/VIAL",
"product_no": "002",
"approval_date": "Sep 8, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MITOMYCIN",
"proprietary_name": "MITOMYCIN",
"active_ingred_unit": "mg/40mL",
"application_number": "ANDA214505",
"marketing_category": "ANDA",
"nonproprietary_name": "MITOMYCIN",
"start_marketing_date": "20220908",
"active_numerator_strength": "20"
}Related drugs
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