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United States · US · US:64380-726_51752987-c49c-40b6-8fe2-1d1c99554312
Mycophenolate mofetil
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerStrides Pharma Science Limited
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116438072606100 CAPSULE in 1 BOTTLE, PLASTIC (64380-726-06)
- ndc116438072607500 CAPSULE in 1 BOTTLE, PLASTIC (64380-726-07)
Annotations
UNII (FDA Substance ID)
9242ECW6R0
MYCOPHENOLATE MOFETIL
RxCUI 68149
Orange Book
A090055
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": "64380-726_51752987-c49c-40b6-8fe2-1d1c99554312",
"productndc": "64380-726",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "090055",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MG",
"product_no": "001",
"approval_date": "Jun 10, 2010"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MYCOPHENOLATE MOFETIL",
"proprietary_name": "Mycophenolate mofetil",
"active_ingred_unit": "mg/1",
"application_number": "ANDA090055",
"marketing_category": "ANDA",
"nonproprietary_name": "Mycophenolate mofetil",
"start_marketing_date": "20101106",
"active_numerator_strength": "250"
}Access this data programmatically
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