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United States · US · US:0781-5175_8d255117-cfa8-4893-8e2e-945eee7b12c4
Mycophenolate Mofetil
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSandoz Inc
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc110781517501100 TABLET, FILM COATED in 1 BOTTLE (0781-5175-01)
- ndc110781517505500 TABLET, FILM COATED in 1 BOTTLE (0781-5175-05)
- ndc1107815175101000 TABLET, FILM COATED in 1 BOTTLE (0781-5175-10)
Annotations
UNII (FDA Substance ID)
9242ECW6R0
MYCOPHENOLATE MOFETIL
RxCUI 68149
Orange Book
A065451
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": "0781-5175_8d255117-cfa8-4893-8e2e-945eee7b12c4",
"productndc": "0781-5175",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "065451",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "001",
"approval_date": "Oct 15, 2008"
}
],
"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": "ANDA065451",
"marketing_category": "ANDA",
"nonproprietary_name": "Mycophenolate Mofetil",
"start_marketing_date": "20081015",
"active_numerator_strength": "500"
}Access this data programmatically
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