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United States · US · US:67457-386_4c643876-2577-4197-ac9b-81bab65d1362
Mycophenolate Mofetil
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Institutional LLC
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1167457386814 VIAL in 1 CARTON (67457-386-81) / 20 mL in 1 VIAL (67457-386-00)
Annotations
UNII (FDA Substance ID)
9242ECW6R0
MYCOPHENOLATE MOFETIL
RxCUI 68149
Orange Book
A203859
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "9242ECW6R0",
"rxcui": "68149",
"inchikey": "RTGDFNSFWBGLEC-SYZQJQIISA-N",
"display_name": "MYCOPHENOLATE MOFETIL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"21ff53b0-b4ba-4473-91e4-76ef41681064": {
"match": "brand_token",
"title": "MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION [ASCEND LABORATORIES, LLC]",
"spl_version": "30",
"published_date": "2026-05-28"
}
},
"productid": "67457-386_4c643876-2577-4197-ac9b-81bab65d1362",
"productndc": "67457-386",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "203859",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "500MG/VIAL",
"product_no": "001",
"approval_date": "Mar 31, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MYCOPHENOLATE MOFETIL",
"proprietary_name": "Mycophenolate Mofetil",
"active_ingred_unit": "mg/20mL",
"application_number": "ANDA203859",
"marketing_category": "ANDA",
"nonproprietary_name": "Mycophenolate Mofetil",
"start_marketing_date": "20210126",
"active_numerator_strength": "500"
}Access this data programmatically
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