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United States · US · US:69238-1595_62350c79-05dc-4568-bd51-489f8221136a
Mycophenolate Mofetil
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals NY LLC
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1169238159521 BOTTLE, PLASTIC in 1 CARTON (69238-1595-2) / 225 mL in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
9242ECW6R0
MYCOPHENOLATE MOFETIL
RxCUI 68149
Orange Book
A214871
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": "69238-1595_62350c79-05dc-4568-bd51-489f8221136a",
"productndc": "69238-1595",
"dosage_form": "POWDER, FOR SUSPENSION",
"orange_book": {
"appl_no": "214871",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG/ML",
"product_no": "001",
"approval_date": "Nov 2, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MYCOPHENOLATE MOFETIL",
"proprietary_name": "Mycophenolate Mofetil",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA214871",
"marketing_category": "ANDA",
"nonproprietary_name": "Mycophenolate Mofetil",
"start_marketing_date": "20211105",
"active_numerator_strength": "200"
}Access this data programmatically
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