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United States · US · US:0904-7466_ee7d4d25-3ca2-4937-9c91-ef7961ce3fe6
mycophenolate mofetil
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMajor Pharmaceuticals
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc110904746661100 BLISTER PACK in 1 CARTON (0904-7466-61) / 1 CAPSULE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
9242ECW6R0
MYCOPHENOLATE MOFETIL
RxCUI 68149
Orange Book
A200197
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": "0904-7466_ee7d4d25-3ca2-4937-9c91-ef7961ce3fe6",
"productndc": "0904-7466",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "200197",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MG",
"product_no": "001",
"approval_date": "Jun 13, 2013"
}
],
"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": "ANDA200197",
"marketing_category": "ANDA",
"nonproprietary_name": "mycophenolate mofetil",
"start_marketing_date": "20251211",
"active_numerator_strength": "250"
}Access this data programmatically
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