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United States · US · US:68254-5003_6eb2ddd0-ab23-44ae-a1ce-acc44e4f7e29
MYCOPHENOLATE MOFETIL
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCONCORD BIOTECH LIMITED
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11682545003130 TABLET in 1 BOTTLE (68254-5003-1)
- ndc116825450032100 TABLET in 1 BOTTLE (68254-5003-2)
- ndc116825450033500 TABLET in 1 BOTTLE (68254-5003-3)
Annotations
UNII (FDA Substance ID)
9242ECW6R0
MYCOPHENOLATE MOFETIL
RxCUI 68149
Orange Book
A212087
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": "68254-5003_6eb2ddd0-ab23-44ae-a1ce-acc44e4f7e29",
"productndc": "68254-5003",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "212087",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "001",
"approval_date": "Jul 31, 2020"
}
],
"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": "ANDA212087",
"marketing_category": "ANDA",
"nonproprietary_name": "MYCOPHENOLATE MOFETIL",
"start_marketing_date": "20201221",
"active_numerator_strength": "500"
}Access this data programmatically
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