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United States · US · US:60687-438_45762f11-5cf6-b346-e063-6394a90a6199
Mycophenolate mofetil
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmerican Health Packaging
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116068743801100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-438-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-438-11)
Annotations
UNII (FDA Substance ID)
9242ECW6R0
MYCOPHENOLATE MOFETIL
RxCUI 68149
Orange Book
A090456
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": "60687-438_45762f11-5cf6-b346-e063-6394a90a6199",
"productndc": "60687-438",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "090456",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"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": "ANDA090456",
"marketing_category": "ANDA",
"nonproprietary_name": "Mycophenolate Mofetil",
"start_marketing_date": "20190614",
"active_numerator_strength": "500"
}Access this data programmatically
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