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United States · US · US:59651-646_83531645-459d-4746-bc46-2d32928e9417
MYCOPHENOLATE MOFETIL
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1159651646261 BOTTLE in 1 CARTON (59651-646-26) / 225 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
9242ECW6R0
MYCOPHENOLATE MOFETIL
RxCUI 68149
Orange Book
A218227
AB
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": "ORAL",
"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": "59651-646_83531645-459d-4746-bc46-2d32928e9417",
"productndc": "59651-646",
"dosage_form": "POWDER, FOR SUSPENSION",
"orange_book": {
"appl_no": "218227",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG/ML",
"product_no": "001",
"approval_date": "Sep 26, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MYCOPHENOLATE MOFETIL",
"proprietary_name": "MYCOPHENOLATE MOFETIL",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA218227",
"marketing_category": "ANDA",
"nonproprietary_name": "mycophenolate mofetil",
"start_marketing_date": "20240926",
"active_numerator_strength": "200"
}Access this data programmatically
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