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United States · US · US:72485-415_42edff88-f01d-0908-e063-6294a90a3b0f
mycophenolate mofetil
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerARMAS PHARMACEUTICALS INC
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1172485415044 VIAL in 1 CARTON (72485-415-04) / 20 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
9242ECW6R0
MYCOPHENOLATE MOFETIL
RxCUI 68149
Orange Book
A216390
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": "72485-415_42edff88-f01d-0908-e063-6294a90a3b0f",
"productndc": "72485-415",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "216390",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "500MG/VIAL",
"product_no": "001",
"approval_date": "Dec 23, 2022"
}
],
"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": "ANDA216390",
"marketing_category": "ANDA",
"nonproprietary_name": "mycophenolate mofetil",
"start_marketing_date": "20230706",
"active_numerator_strength": "500"
}Access this data programmatically
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