🇺🇸
United States · US · US:0054-0166_d938a1b7-eed3-4e23-bfef-f88c443d9267
Mycophenolate Mofetil
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc110054016629500 TABLET in 1 BOTTLE (0054-0166-29)
- ndc110054016625100 TABLET in 1 BOTTLE (0054-0166-25)
Annotations
UNII (FDA Substance ID)
9242ECW6R0
MYCOPHENOLATE MOFETIL
RxCUI 68149
Orange Book
A065413
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": "0054-0166_d938a1b7-eed3-4e23-bfef-f88c443d9267",
"productndc": "0054-0166",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "065413",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "001",
"approval_date": "Jul 29, 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": "ANDA065413",
"marketing_category": "ANDA",
"nonproprietary_name": "Mycophenolate Mofetil",
"start_marketing_date": "20080729",
"active_numerator_strength": "500"
}Access this data programmatically
Query Mycophenolate Mofetil and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.